FSGSPhase 2NCT03536754

A Study of CCX140-B in Subjects With FSGS

A Phase 2 study testing CCX140-B in people with FSGS and Focal Segmental Glomerulosclerosis, run by Amgen at 37 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate the Safety and Efficacy of CCX140-B in Subjects with FSGS to be conducted in the North America, Europe and Australia Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: FSGS, Focal Segmental Glomerulosclerosis, Glomerulosclerosis
What is being tested?: CCX140-B
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 46 participants
Where: 37 sitesin 8 countries
Study dates: 17 May 2018to 19 Feb 2020
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female subjects aged 18-75
UPCR ≥ 1 g protein/g creatinine (or at 113 mg.mmol) at screening
Diagnosis of FSGS based on renal biopsy or high risk genetic variant
Diagnosis of one of primary FSGS based on characteristic histopathology, medical history and clinical course or FSGS secondary to genetic variants associated with increased risk or severity.
Estimated glomerular filtration rate (eGFR) >30 mL/min/1.73m2
Clinical stable blood pressure not to exceed 145/95 mmHg

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RAAS blockers must be stable for at least 4 weeks prior to screening and projected to remain stable through week 12, unless adjustments are required for management of hypertension.
Immunosuppressive or immunomodulatory therapy must be stable for at least 4 weeks prior to screening and projected to remain stable through study week 12
Glucocorticoids must be stable for at least 4 weeks prior to screening and projected to remain stable through study week 12.
Both genders of childbearing potential must agree to use adequate contraception during and for at least 3 months after the last dose of study drug.
Subjects must be willing and able to give written Informed Consent and to comply with protocol requirements.
Subjects must be judged to be otherwise fit for the study by the Investigator. -

Who cannot join

Pregnant or nursing
History of organ transplantation
On an organ transplant waiting list or anticipated organ transplant within 6 months of screening
Anti-CD20 monoclonal antibodies within 20 months of screening are exclusionary. Subjects that used anti CD20 monoclonal antibodies prior to week 20 are allowed with confirmed recovery of CD20+ B cell population to within normal range
Plasmapheresis within 12 weeks of screening
BMI ≥40

Show all 24Show fewer

Participation in any clinical study of an investigational product within 12 weeks or 5 half-lives of screening
Currently on dialysis or likely to require dialysis during the blinded treatment phase of the study.
History or presence of any form of cancer within 5 years of screening except excised basal cell or squamous cell carcinoma or carcinoma in situ such as cervical or breast carcinoma in situ that has been excised or completed resected without evidence or recurrence.
Positive HBV, HCV, or HIV viral screening test. Subjects who have received highly effective therapy for HCV demonstrated to have negative viral titers for at least 6 months following discontinuation of treatment, will be considered to have a negative HCV screening test
Renal disease associated with disorders other than FSGS that is active or has significant risk of progressing during the course of the study.
Disorders that are associated with FSGS lesions.
Evidence of tuberculosis.
Evidence of hepatic disease with the exception that isolated INR elevation in the absence of other significant liver enzyme abnormalities is explained by anticoagulant therapy, (e.g. warfarin)
Hematologic abnormalities as follows: Hb <8 g/dL, platelets <50,000, ANC <1000 cells/µL) at baseline.
QTcF greater than 450 msec.
History of alcohol or illicit drug abuse or of lithium, pamidronate and interferon. Recreational use of cannabis is not excluded where legal.
History of gastrointestinal conditions that may interfere with study medication compliance.
Known hypersensitivity to CCX140-B or inactive ingredients of the CCX140-B tablets (including microcrystalline cellulose, starch, crospovidone, magnesium stearate, or silicon dioxide).
History or presence of systemic disorder other than FSGS that requires, or is expected to require, systemic glucocorticoids or immune modulators during the study; topical or inhaled glucocorticoids and immune modulators are not excluded.
History or presence of any medical condition or disease which, in the opinion of the Investigator, may place the subject at unacceptable risk for study participation.
Subjects taking strong CYP3A4 inducers or strong CYP3A4 inhibitors within two weeks prior to screening.
Subjects taking lithium or interferon; subjects taking non-steroidal anti-inflammatory agents (NSAIDS) chronically (intermittent, i.e. occasional NSAIDS for pain or fever is discouraged, but is not excluded).
-

Trial locations and contacts

37 sites in 8 countries.

Country

City, postcode or hospital

37 sites in 8 countries

United States9 sites

MGH
Boston, Massachusetts, 02114
East Carolina University
Greenville, North Carolina, 27834
University of Texas Health Sciences Center
Houston, Texas, 77030
University of Minnesota
Minneapolis, Minnesota, 55414
AKDHC
Phoenix, Arizona, 85016
Rhode Island Hospital
Providence, Rhode Island, 02903
Utah Kidney Research Institute
Salt Lake City, Utah, 84115
Northwest Louisiana Nephrology
Shreveport, Louisiana, 71101
Los Angeles Biomedical Research Institute
Torrance, California, 90502

Other trials in United States

France5 sites

CHU Bordeaux- Hospital Pellegrin
Bordeaux, 33076
CHU Henri Mondor
Créteil, 94010
CHU de Grenoble
Grenoble, 38043
APHM - Hopital de la Conception
Marseille, 13385
Hopitaux Prives de Metz
Metz, 57045

Other trials in France

Italy5 sites

Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
Bergamo, 24127
IRCCS Azienda Ospedaliera Universitaria San Martino IST
Genova, 16132
Presidio Ospedaliero di Montichiari-A.O. Spedali Civili di Brescia
Montichiari, 25018
Fondazione S. Maugeri IRCCS
Pavia, 27100
Fondazione Policlinico Universitario A. Gemelli - Universita Cattolica del Sacro Cuore
Rome, 00168

Other trials in Italy

Poland5 sites

Uniwersytecki Szpital Kliniczny w Bialymstoku - II Klinika Nefrologii z Oddzialem Leczenia Nadcisnienia Tetniczego i Pododdzialem Dializoterapii
Bialystok, 15-276
SCM Sp. Zo.o.
Krakow
Samodzielny Publiczny Zaklad Opieki Zdrowotnez Centralny Szpital
Lodz
Samodzielny Publiczny Szpital Kliniczny
Szczecin
Uniwersytecki Szpital Kliniczny Klinika Nefrologii i Medycyny Transplantacyjnej
Wroclaw, 50-556

Other trials in Poland

Canada4 sites

CISSS de la Monteregie-Centre - Hopital Charles LeMoyne
Greenfield Park, Quebec, J4V2H1
St. Josephs Healthcare - Hamilton
Hamilton, Ontario, L8N4A6
Sunnybrook Health Sciences Centre (Odette Cancer Center)
Toronto, Ontario, M4G 3E8
Toronto General Hospital
Toronto, Ontario, M5G2C4

Other trials in Canada

United Kingdom4 sites

Cambridge University - Addenbrooke's Hospital
Cambridge, CB2 0OQ
University Hospital of Wales
Cardiff, CF14 4XW
Salford Royal NHS Foundation Trust Manchester
Salford, M6 8HD
Morriston Hospital
Swansea, SA6 6NL

Other trials in United Kingdom

Australia3 sites

Monash Medical Centre
Clayton, Victoria, 3168
Austin Health
Heidelberg, Victoria, 3084
Royal Melbourne Hospital
Parkville

Other trials in Australia

New Zealand2 sites

Taranaki Base Hospital
New Plymouth, 4310
North Shore Hospital
Takapuna, Auckland, 0622

Other trials in New Zealand

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate the Safety and Efficacy of CCX140-B in Subjects With Focal Segmental Glomerulosclerosis (FSGS)

Read the detailed description

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate the Safety and Efficacy of CCX140-B in Subjects with Focal Segmental Glomerulosclerosis (FSGS) to be conducted in the North America, Europe and Australia. The aim of this study is to evaluate the effect of treatment with CCX140-B, a selective antagonist of C-C chemokine receptor type 2 in subjects with focal segmental glomerulosclerosis on urinary protein excretion as assessed by changes in urine protein to creatinine ratio (UPCR).

Study acquired by Amgen and all disclosures were done by previous sponsor ChemoCentryx.

Conditions: FSGS, Focal Segmental Glomerulosclerosis, Glomerulosclerosis
Being tested: Placebo, CCX140-B
Medical subject headings: Glomerulosclerosis, Focal Segmental

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PlaceboOther
Also called CCX140-B Placebo
Three placebo tablets, taken twice daily (BID), per os, for 84 days (12 weeks)
CCX140-BDrug
Also called Group B
One 5 mg CCX140-B tablet and 2 placebo tablets in the morning; 3 placebo tablets in the evening; per os, for 84 days.
CCX140-BDrug
Also called Group C
Two 5 mg CCX140-B tablets and 1 placebo tablet, taken BID; per os, for 84 days.
CCX140-BDrug
Also called Group D
Three 5 mg CCX140-B tablets, taken BID; per os, for 84 days.

Study groups in NCT03536754
Study group	Role	What they receive
Group A	Placebo comparator	Placebo (N=10) Receives: Other: Placebo
Group B	Experimental	CCX140-B 5 mg once daily (N=10) Receives: Drug: CCX140-B
Group C	Experimental	CCX140-B 10 mg twice daily (N=10) Receives: Drug: CCX140-B
Group D	Experimental	CCX140-B 15 mg twice daily (N=10) Receives: Drug: CCX140-B

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in UPCR at Week 12
Least squared mean ratio of UPCR (Urine protein g:creatinine g) compared to baseline at Week 12 in the ITT population. ITT- Intent to treat
Measured: Baseline to Week 12
Number of Participants of Treatment-emergent AEs (TEAE), TEAEs Leading to Study Withdrawal, and Serious Adverse Events (SAEs)
TEAEs leading to study withdrawal means study drug discontinuation in this endpoint.
Measured: Baseline to Week 12, and Week 12 to Week 24
Change From Baseline in Activated Partial Thromboplastin Time
Normal Range: 23.9 - 40.0
Measured: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Plasma Alanine Aminotransferase
Normal Range: 6 - 41 U/L
Measured: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Plasma Alkaline Phosphatase
Measured: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Plasma Amylase
Normal range: 22-123 U/L
Measured: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Plasma Aspartate Aminotransferase
Normal range : 9-34 U/L
Measured: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Plasma Bicarbonate
Normal range: 21-33 mmol/L
Measured: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Plasma Bilirubin
Normal range: 0.1-1.10 mg/dL
Measured: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Plasma C Reactive Protein
Normal range: 0.0-3.0 mg/L
Measured: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Plasma Calcium
Normal range: 8.5-10.5 mg/dL
Measured: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Plasma Chloride
Normal range: 95-110 mmol/L
Measured: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Plasma Cholesterol
Normal range: 100-200 mg/dL
Measured: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Plasma Creatine Kinase
Normal range: 23-210 U/L
Measured: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Plasma Creatinine
Normal range: 0.62-1.44 mg/dL
Measured: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Plasma Cystatin C
Normal range: 0.53-0.95 mg/L
Measured: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Plasma Direct Bilirubin
Measured: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Plasma Glucose
Measured: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Plasma HDL Cholesterol
HDL -High-density lipoprotein
Measured: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Plasma Indirect Bilirubin
Measured: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Plasma LDL Cholesterol
LDL - Low-density lipoprotein
Measured: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Lactate Dehydrogenase
Measured: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Plasma Pancreatic Lipase
Measured: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Plasma Magnesium
Measured: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Plasma Phosphate
Measured: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Plasma Potassium
Measured: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Plasma Protein
Measured: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Prothrombin Intl. Normalised Ratio
Measured: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Prothrombin Time
Measured: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Plasma Sodium
Measured: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Plasma Triglycerides
Measured: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Plasma Urate
Measured: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Plasma Urea Nitrogen
Measured: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Basophils
Measured: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Basophils/Leukocytes
Measured: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Eosinophils
Measured: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Eosinophils/Leukocytes
Measured: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Erythrocyte Mean Corpuscular HGB Concentration
HGB - Hemoglobin
Measured: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin
Measured: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Erythrocyte Mean Corpuscular Volume
Measured: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Erythrocytes
Measured: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Hematocrit
Measured: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Hemoglobin
Measured: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Leukocytes
Measured: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Lymphocytes
Measured: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Lymphocytes/Leukocytes
Measured: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Monocytes/Leukocytes
Measured: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Neutrophils
Measured: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Neutrophils/Leukocytes
Measured: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Platelets
Measured: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Reticulocytes/Erythrocytes
Measured: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Urine Albumin
Measured: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Urine Creatinine
Measured: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Urine Protein
Measured: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

Secondary outcomes (2)

Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 12 and Week 24
Change from baseline in eGFR calculated by the CKD-EPI Cystatin C equation, CKD-EPI Creatinine equation, CKD-EPI Creatinine-Cystatin C equation and MDRD Creatinine equation at Weeks 12 and 24. CKD-EPI: Chronic Kidney Disease Epidemiology Collaboration; MDRD: Modification of Diet in Renal Disease Open label extension covers Baseline to Week 12 and Baseline to Week 24
Measured: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Proportion of Subjects Achieving Complete or Partial Renal Remission at Week 12 and Week 24
1. Proportion of subjects achieving complete renal remission by the following definition at Weeks 12 and 24 o Reduction in UPCR to <0.3 g/g o Serum albumin within normal range (for subjects with abnormal serum creatinine levels at baseline, return to normal levels for that age group; for subjects with normal serum creatinine levels at baseline, final value within 20% of baseline levels) 2. Proportion of subjects achieving partial remission defined as UPCR reduction of ≥50% from baseline and UPCR <3.5 g/g (definition 1), assessed at Weeks 12 and 24 3. Proportion of subjects achieving partial remission defined Decrease in UPCR to less than 1.5 g/g and at least a 40% reduction in proteinuria from baseline (definition 2), assessed at Weeks 12 and 24
Measured: Endpoint at Week 12 for Double-Blind Treatment Period and Endpoint at Week 24 for Open-Label Extension

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 May 201819 Feb 2020

First posted25 May 2018
Study start17 May 2018
Primary completion19 Feb 2020
Study completion19 Feb 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for FSGSStudies of the same condition, open and under way.
More trials run by AmgenThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Model description: Randomized, placebo-controlled, Phase 2
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 46 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03536754
Sponsor's protocol ID: CL011_140
Other IDs: LUMINA-1, NCT03536754, 134007
Status last verified: Mar 2025
First submitted: 28 Mar 2018
Last updated: 13 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Hodson EM, Sinha A, Cooper TE. Interventions for focal segmental glomerulosclerosis in adults. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD003233. doi: 10.1002/14651858.CD003233.pub3.
PubMed 35224732

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate the Safety and Efficacy of CCX140-B in Subjects With Focal Segmental Glomerulosclerosis (FSGS)
ClinicalTrials.gov ID: NCT03536754
Acronym / sponsor ID: CL011_140
Conditions: FSGS, Focal Segmental Glomerulosclerosis, Glomerulosclerosis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 46 participants (actual)
Lead sponsor: AmgenIndustry (pharma, biotech, devices)
Study start: 17 May 2018 (actual)
Primary completion: 19 Feb 2020 (actual)
Study completion: 19 Feb 2020 (actual)
First posted: 25 May 2018 (actual)
Results: Posted 5 Dec 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study acquired by Amgen and all disclosures were done by previous sponsor ChemoCentryx.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 4
Model description: Randomized, placebo-controlled, Phase 2

Arm	Type	Receives
Group A	Placebo comparator	Other: PlaceboPlacebo (N=10)
Group B	Experimental	Drug: CCX140-BCCX140-B 5 mg once daily (N=10)
Group C	Experimental	Drug: CCX140-BCCX140-B 10 mg twice daily (N=10)
Group D	Experimental	Drug: CCX140-BCCX140-B 15 mg twice daily (N=10)

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

Male or female subjects aged 18-75
UPCR ≥ 1 g protein/g creatinine (or at 113 mg.mmol) at screening
Diagnosis of FSGS based on renal biopsy or high risk genetic variant
Diagnosis of one of primary FSGS based on characteristic histopathology, medical history and clinical course or FSGS secondary to genetic variants associated with increased risk or severity.
Estimated glomerular filtration rate (eGFR) >30 mL/min/1.73m2

Key exclusion criteria (24 listed)

Pregnant or nursing
History of organ transplantation
On an organ transplant waiting list or anticipated organ transplant within 6 months of screening
Anti-CD20 monoclonal antibodies within 20 months of screening are exclusionary. Subjects that used anti CD20 monoclonal antibodies prior to week 20 are allowed with confirmed recovery of CD20+ B cell population to within normal range
Plasmapheresis within 12 weeks of screening

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PlaceboAlso: CCX140-B PlaceboThree placebo tablets, taken twice daily (BID), per os, for 84 days (12 weeks)	Other	Group A
CCX140-BAlso: Group BOne 5 mg CCX140-B tablet and 2 placebo tablets in the morning; 3 placebo tablets in the evening; per os, for 84 days.	Drug	Group B
CCX140-BAlso: Group CTwo 5 mg CCX140-B tablets and 1 placebo tablet, taken BID; per os, for 84 days.	Drug	Group C
CCX140-BAlso: Group DThree 5 mg CCX140-B tablets, taken BID; per os, for 84 days.	Drug	Group D

Primary outcome

Change From Baseline in UPCR at Week 12
Time frame: Baseline to Week 12
Least squared mean ratio of UPCR (Urine protein g:creatinine g) compared to baseline at Week 12 in the ITT population. ITT- Intent to treat
Number of Participants of Treatment-emergent AEs (TEAE), TEAEs Leading to Study Withdrawal, and Serious Adverse Events (SAEs)
Time frame: Baseline to Week 12, and Week 12 to Week 24
TEAEs leading to study withdrawal means study drug discontinuation in this endpoint.
Change From Baseline in Activated Partial Thromboplastin Time
Time frame: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Normal Range: 23.9 - 40.0
Change From Baseline in Plasma Alanine Aminotransferase
Time frame: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Normal Range: 6 - 41 U/L
Change From Baseline in Plasma Alkaline Phosphatase
Time frame: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Plasma Amylase
Time frame: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Normal range: 22-123 U/L
Change From Baseline in Plasma Aspartate Aminotransferase
Time frame: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Normal range : 9-34 U/L
Change From Baseline in Plasma Bicarbonate
Time frame: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Normal range: 21-33 mmol/L
Change From Baseline in Plasma Bilirubin
Time frame: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Normal range: 0.1-1.10 mg/dL
Change From Baseline in Plasma C Reactive Protein
Time frame: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Normal range: 0.0-3.0 mg/L
Change From Baseline in Plasma Calcium
Time frame: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Normal range: 8.5-10.5 mg/dL
Change From Baseline in Plasma Chloride
Time frame: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Normal range: 95-110 mmol/L
Change From Baseline in Plasma Cholesterol
Time frame: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Normal range: 100-200 mg/dL
Change From Baseline in Plasma Creatine Kinase
Time frame: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Normal range: 23-210 U/L
Change From Baseline in Plasma Creatinine
Time frame: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Normal range: 0.62-1.44 mg/dL
Change From Baseline in Plasma Cystatin C
Time frame: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Normal range: 0.53-0.95 mg/L
Change From Baseline in Plasma Direct Bilirubin
Time frame: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Plasma Glucose
Time frame: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Plasma HDL Cholesterol
Time frame: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
HDL -High-density lipoprotein
Change From Baseline in Plasma Indirect Bilirubin
Time frame: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Plasma LDL Cholesterol
Time frame: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
LDL - Low-density lipoprotein
Change From Baseline in Lactate Dehydrogenase
Time frame: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Plasma Pancreatic Lipase
Time frame: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Plasma Magnesium
Time frame: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Plasma Phosphate
Time frame: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Plasma Potassium
Time frame: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Plasma Protein
Time frame: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Prothrombin Intl. Normalised Ratio
Time frame: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Prothrombin Time
Time frame: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Plasma Sodium
Time frame: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Plasma Triglycerides
Time frame: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Plasma Urate
Time frame: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Plasma Urea Nitrogen
Time frame: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Basophils
Time frame: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Basophils/Leukocytes
Time frame: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Eosinophils
Time frame: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Eosinophils/Leukocytes
Time frame: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Erythrocyte Mean Corpuscular HGB Concentration
Time frame: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
HGB - Hemoglobin
Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin
Time frame: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Erythrocyte Mean Corpuscular Volume
Time frame: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Erythrocytes
Time frame: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Hematocrit
Time frame: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Hemoglobin
Time frame: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Leukocytes
Time frame: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Lymphocytes
Time frame: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Lymphocytes/Leukocytes
Time frame: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Monocytes/Leukocytes
Time frame: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Neutrophils
Time frame: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Neutrophils/Leukocytes
Time frame: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Platelets
Time frame: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Reticulocytes/Erythrocytes
Time frame: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Urine Albumin
Time frame: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Urine Creatinine
Time frame: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Change From Baseline in Urine Protein
Time frame: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

2 secondary outcomes

Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 12 and Week 24
Time frame: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
Proportion of Subjects Achieving Complete or Partial Renal Remission at Week 12 and Week 24
Time frame: Endpoint at Week 12 for Double-Blind Treatment Period and Endpoint at Week 24 for Open-Label Extension

Results and safety

Results posted to the registry on 5 Dec 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	12	12
CCX140-B 5 mg Once Daily	11	11
CCX140-B 10 mg Twice Daily	12	11
CCX140-B 15 mg Twice Daily	11	11
Open-label Extension	0	0

Primary outcome: Change From Baseline in UPCR at Week 12

Time frame: Baseline to Week 12. Least squares mean (90% Confidence Interval). Unit: g protein/g creatinine

Measure	Placebo n = 12	CCX140-B 5 mg Once Daily n = 11	CCX140-B 10 mg Twice Daily n = 11	CCX140-B 15 mg Twice Daily n = 11
Value	0.83 (0.69 to 0.99)	1.02 (0.84 to 1.23)	1.12 (0.93 to 1.35)	0.87 (0.72 to 1.05)

Placebo vs CCX140-B 5 mg Once Daily: LSM Ratio: 1.23 (90% CI 0.95 to 1.6), p = 0.1924, Mixed effects model for repeated measure
Placebo vs CCX140-B 10 mg Twice Daily: LSM Ratio: 1.35 (90% CI 1.04 to 1.76), p = 0.0612, Mixed effects model for repeated measure
Placebo vs CCX140-B 15 mg Twice Daily: LSM Ratio: 1.05 (90% CI 0.81 to 1.36), p = 0.7653, Mixed effects model for repeated measure

Primary outcome: Number of Participants of Treatment-emergent AEs (TEAE), TEAEs Leading to Study Withdrawal, and Serious Adverse Events (SAEs)

Time frame: Baseline to Week 12, and Week 12 to Week 24. Count of participants. Unit: Participants

Measure	Placebo n = 12	CCX140-B 5 mg Once Daily n = 11	CCX140-B 10 mg Twice Daily n = 12	CCX140-B 15 mg Twice Daily n = 11	Open-label Extension n = 43
TEAEs	10	6	8	7	24
SAEs	0	0	0	0	1
TEAEs leading to study withdrawal	0	0	1	0	2

Primary outcome: Change From Baseline in Activated Partial Thromboplastin Time

Time frame: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension). Mean (Standard Deviation). Unit: second

Measure	Placebo n = 12	CCX140-B 5 mg Once Daily n = 10	CCX140-B 10 mg Twice Daily n = 10	CCX140-B 15 mg Twice Daily n = 10	Open-label Extension n = 40
Week 12	2.40 (4.259)	2.05 (4.396)	2.36 (2.614)	1.28 (2.508)	1.76 (4.332)
Week 24	2.91 (4.132)	1.39 (3.187)	2.34 (6.169)	0.10 (3.223)	1.76 (4.332)

Population analysed: Data is not available for all participants.

Primary outcome: Change From Baseline in Plasma Alanine Aminotransferase

Time frame: Baseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension). Mean (Standard Deviation). Unit: U/L

Measure	Placebo n = 12	CCX140-B 5 mg Once Daily n = 11	CCX140-B 10 mg Twice Daily n = 11	CCX140-B 15 mg Twice Daily n = 11	Open-label Extension n = 41
Value	0.5 (2.70)	0.8 (5.22)	0.3 (3.29)	-1.8 (2.95)	0.0 (3.65)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From Baseline to Week 24. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 11 (0%)	7 of 11 (63.6%)	0 of 11
CCX140-B 5 mg	0 of 11 (0%)	8 of 11 (72.7%)	0 of 11
CCX140-B 10 mg	0 of 12 (0%)	10 of 12 (83.3%)	0 of 12
CCX140-B 15 mg	0 of 11 (0%)	8 of 11 (72.7%)	0 of 11
Placebo Open Label	0 of 11 (0%)	7 of 11 (63.6%)	0 of 11
CCX140-B 5mg Open Label	0 of 11 (0%)	6 of 11 (54.5%)	0 of 11
CCX140-B 10mg Open Label	1 of 11 (9.1%)	6 of 11 (54.5%)	0 of 11
CCX140-B 15mg Open Label	0 of 10 (0%)	5 of 10 (50%)	0 of 10

Limitations and caveats (from the sponsor): Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35224732Hodson EM, Sinha A, Cooper TE. Interventions for focal segmental glomerulosclerosis in adults. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD003233. doi: 10.1002/14651858.CD003233.pub3.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

MD study director

Amgen

37 sites in 8 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CCX140-B in people with FSGS and Focal Segmental Glomerulosclerosis, run by Amgen at 37 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in United States, France, Italy, Poland, Canada and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in UPCR at Week 12 (time frame: Baseline to Week 12). The study lists 54 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03536754, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025; AzTrials last refreshed its copy on 26 Oct 2026.