Chronic Kidney DiseasePhase 2NCT00761657

Phase 2 Study of Roxadustat in Participants With Anemia and Chronic Kidney Disease Not Requiring Dialysis

A Phase 2 study testing Roxadustat in people with Chronic Kidney Disease and Anemia, run by Kyntra Bio at 34 sites in United States.

Completed

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

Official record

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Trial summary

The primary objective of the study is to evaluate the safety, tolerability, and pharmacodynamic effects of different oral doses of roxadustat administered 2 times a week (BIW) or 3 times a week (TIW) for up to 4 weeks to participants with chronic kidney disease (CKD) not requiring dialysis. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Chronic Kidney Disease, Anemia
What is being tested?: Roxadustat
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 117 participants
Where: 34 sitesUnited States
Study dates: 1 Nov 2006to 21 Jun 2010
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 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

18 to 80 years of age. Participants aged over 75 years but otherwise meet all other participant selection criteria will be evaluated on a case-by-case basis and can be included in this study, per discretion of Sponsor's physician representative such as medical monitor or clinical leader.
Chronic Kidney Disease Stage 3 or 4 with hemoglobin <11.0 grams (g)/deciliter (dL).
Normal iron studies.
Normal folate and vitamin B12 levels.
Liver function tests within normal limits at screening.
Absence of active or chronic rectal bleeding.

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Absence of diagnosis of age-related macular degeneration (AMD), diabetic macular edema, or diabetic proliferative retinopathy that is likely to require treatment during the trial.
Female participants must not be pregnant nor breastfeeding and agree to use acceptable method of contraception.
Male participants with partners who can have children must agree to use a medically acceptable method of contraception.

Who cannot join

Seropositive for HIV.
History of chronic liver disease.
History of polycystic kidney disease (PKD).
Uncontrolled hypertension (diastolic BP >110 millimeter of mercury (mmHg) or systolic BP >170 mmHg at screening).
New York Heart Association Class III or IV congestive heart failure.
Recent myocardial infarction or acute coronary syndrome.

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History of myelodysplastic syndrome.
Any history of malignancy or a known genetic predisposition for developing cancer (for example, with diagnostic markers suggesting a genetic predisposition of cancer) except for curatively resected basal cell carcinoma of skin, squamous cell carcinoma of skin, cervical carcinoma in situ, or resected benign colonic polyps.
Active inflammatory infection or chronic inflammatory disease.
Any clinically significant and uncontrolled medical condition considered a high risk for participation in an investigational study.
Blood clots within 4 weeks.
History of ongoing hemolysis or diagnosis of hemolytic syndrome.
Known history of bone marrow fibrosis.
History of hemosiderosis or hemochromatosis.
Androgen therapy within 12 weeks.
Red blood cell transfusion within 12 weeks.
Therapy with an erythropoiesis stimulating agent (ESA) such as human recombinant erythropoietin within the past 60 days.
Intravenous iron supplementation within the past 60 days.
Currently taking dapsone or acetaminophen >2.6 g/day.
History of prior organ transplantation.
Alcohol consumption greater than 3 or more drinks per day within the past year.
Use of an investigational medication or participation in an investigational study within 4 weeks preceding Day 1.
Positive urine toxicology screen for a substance that has not been prescribed for the participant.

Trial locations and contacts

34 sites in 1 country.

City, postcode or hospital

34 sites in 1 country

United States34 sites

Study site
Arvada, Colorado, 80002
Study site
Augusta, Georgia, 30901
Study site
Baton Rouge, Louisiana, 70809
Study site
Chattanooga, Tennessee, 37404
Study site
Chicago, Illinois, 60616
Study site
Cleveland, Ohio, 44109
Study site
Columbia, South Carolina, 29203
Study site
Detroit, Michigan, 48236
Study site
Evergreen Park, Illinois, 60805
Study site
Flushing, New York, 11355
Study site
Houston, Texas, 77036
Study site
Las Vegas, Nevada, 89106
Study site
Lincoln, Nebraska, 68510
Study site
Los Angeles, California, 90095
Study site
Louisville, Kentucky, 40202
Study site
Medford, Oregon, 97504
Study site
Middlebury, Connecticut, 06762
Study site
Mission Viejo, California, 92691
Study site
Ocala, Florida, 34471
Study site
Orangeburg, South Carolina, 29118
Study site
Panama City, Florida, 32401
Study site
Pembroke Pines, Florida, 33028
Study site
Peoria, Arizona, 85381
Study site
Sacramento, California, 95825
Study site
San Diego, California, 92123
Study site
Shreveport, Louisiana, 71101
Study site
Tampa, Florida, 33614
Study site
Tempe, Arizona, 85284
Study site
Toledo, Ohio, 43606
Study site
Westminster, Colorado, 80031
Study site
Whittier, California, 90603
Study site
Wichita, Kansas, 67214
Study site
Winston-Salem, North Carolina, 27103
Study site
Wynnewood, Pennsylvania, 19096

Other trials in United States

About this study

Official title: A Randomized, Single-blind, Placebo-controlled, 4-Week Treatment Study of the Safety and Biologic Activity of Escalating Multiple Oral Doses of FG-4592 in Subjects With Chronic Kidney Disease Not Requiring Dialysis

Read the detailed description

This study in participants with CKD not requiring dialysis was conducted in 2 parts (designated Part 1 and Part 2). Part 1 evaluated roxadustat doses at 1.0 and 2.0 milligrams/kilograms (mg/kg). Part 2 evaluated roxadustat doses at 0.7, 1.5, and 2.0 mg/kg.

On 08 May 2007, the Food and Drug Administration (FDA) placed a clinical hold on the study until evaluation of a report of a death due to fulminant hepatic failure in a participant with CKD in a FibroGen-sponsored clinical trial of another hypoxia inducible factor-prolyl hydroxylase inhibitor (HIF-PHI) (FG-2216) being investigated for treatment of anemia in participants with CKD and other diseases. The clinical hold resulted in early termination of Part 1 of the study. On 24 March 2008, the FDA lifted the clinical hold and Part 2 of this study started.

Conditions: Chronic Kidney Disease, Anemia
Being tested: Roxadustat, Placebo
Keywords: Kidney, Chronic Kidney Disease, CKD, Stage 3 or 4 Chronic Kidney Disease, Renal, Anemia, Oral anemia treatment, Hemoglobin levels, Blood count, Erythropoietin
Medical subject headings: Renal Insufficiency, Chronic, Anemia

What participants receive

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

RoxadustatDrug
Also called FG-4592
Capsule
PlaceboDrug
Capsule

Study groups in NCT00761657
Study group	Role	What they receive
Roxadustat 0.7 mg/kg BIW	Experimental	Participants will receive roxadustat 0.7 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days. Receives: Drug: Roxadustat
Roxadustat 0.7 mg/kg TIW	Experimental	Participants will receive roxadustat 0.7 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days. Receives: Drug: Roxadustat
Roxadustat 1.0 mg/kg BIW	Experimental	Participants will receive roxadustat 1.0 mg/kg BIW orally with doses administered at least 72 hours apart for 29 days. Receives: Drug: Roxadustat
Roxadustat 1.0 mg/kg TIW	Experimental	Participants will receive roxadustat 1.0 mg/kg TIW orally with doses administered at least 48 hours apart for 26 days. Receives: Drug: Roxadustat
Roxadustat 1.5 mg/kg BIW	Experimental	Participants will receive roxadustat 1.5 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days. Receives: Drug: Roxadustat
Roxadustat 1.5 mg/kg TIW	Experimental	Participants will receive roxadustat 1.5 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days. Receives: Drug: Roxadustat
Roxadustat 2.0 mg/kg BIW	Experimental	Participants will receive roxadustat 2.0 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days. Receives: Drug: Roxadustat
Roxadustat 2.0 mg/kg TIW	Experimental	Participants will receive roxadustat 2.0 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days. Receives: Drug: Roxadustat
Placebo	Placebo comparator	Participants will receive placebo orally, matching to the roxadustat dose, number of days per week, and duration. Receives: Drug: Placebo

What is being measured

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

Primary Safety Outcome Measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Treatment Discontinuation (Parts 1 and 2 Combined)
An adverse event (AE) was any untoward medical event in a participant who received study drug whether or not the event is considered drug related. TEAEs defined as an AE beginning after first dose of study drug until 28 days after last dose of study drug or existing AEs that worsened after first dose of study drug until the participant's last study visit. Severe AEs defined as incapacitating, inability to perform usual activities. Drug-related TEAEs defined as TEAEs with possible, probable, or definite relationship to study drug. Serious AE criteria included death, life-threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed here. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Measured: Baseline up to Week 16 (End of Study (EoS])
Co-Primary Efficacy Outcome Measure: Change From Baseline in Hb at Day 26-29 (End of Treatment)
Mean Hb change from baseline was analyzed by treatment group and study visit. Baseline was defined as the mean of last 3 available values prior to the first dose.
Measured: Baseline, End of Treatment (EoT) (Day 26 for TIW Dosing or Day 29 for BIW Dosing)
Co-Primary Efficacy Outcome Measure: Change From Baseline in Hb at Week 8 (2 Weeks of Follow Up)
Mean Hb change from baseline was analyzed by treatment group and study visit. Baseline is defined as the mean of last 3 available values prior to the first dose.
Measured: Baseline, Week 8 (2 Weeks of Follow Up)

Secondary outcomes (4)

Number of Participants With a Hemoglobin Response (Not Due to a RBC Transfusion or IV Iron Supplementation During Treatment)
Hb response defined as an increase in Hb from baseline by ≥1.0 g/dL (not due to red blood cell transfusion or IV iron supplementation during treatment). The baseline for Hb was defined as the mean of the last 3 available Hb values obtained prior to the first dose.
Measured: Baseline up to Day 26-29 (EoT), up to Week 8 (2 weeks of follow up), and up to Week 16 (EoS, 4 weeks of follow up)
Plasma Roxadustat Concentration (Part 2)
Measured: Predose on Days 3 (TIW dose groups) or 4 (BIW dose groups), 8, 15, 22, and 26 (TIW dose groups) or 29 (BIW dose groups)
Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29
Baseline is defined as the last value obtained prior to the first dose.
Measured: Baseline (Day 1), 1, 2, 3, 4, 6, 8, 12, 18, 24, 48, and 72 hours on Day 26 (TIW Dosing) or Day 29 (BIW Dosing)
Change From Baseline in Plasma Erythropoietin in Part 2 Participants at 4, 8, 12, and 24 Hours on Day 1
Baseline is defined as the last value obtained prior to the first dose.
Measured: Baseline, 4, 8, 12, and 24 hours on Day 1

Timeline

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

1 Nov 200621 Jun 2010

First posted29 Sep 2008 (estimated)
Study start1 Nov 2006
Primary completion21 Jun 2010
Study completion21 Jun 2010

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 (2)Papers the sponsor has linked to this study.
Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
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: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 117 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00761657
Sponsor's protocol ID: FGCL-SM4592-017
Status last verified: Nov 2021
First submitted: 25 Sep 2008
Last updated: 19 Nov 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2.
PubMed 36005278
Besarab A, Provenzano R, Hertel J, Zabaneh R, Klaus SJ, Lee T, Leong R, Hemmerich S, Yu KH, Neff TB. Randomized placebo-controlled dose-ranging and pharmacodynamics study of roxadustat (FG-4592) to treat anemia in nondialysis-dependent chronic kidney disease (NDD-CKD) patients. Nephrol Dial Transplant. 2015 Oct;30(10):1665-73. doi: 10.1093/ndt/gfv302. Epub 2015 Aug 3.
PubMed 26238121

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 19 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Single-blind, Placebo-controlled, 4-Week Treatment Study of the Safety and Biologic Activity of Escalating Multiple Oral Doses of FG-4592 in Subjects With Chronic Kidney Disease Not Requiring Dialysis
ClinicalTrials.gov ID: NCT00761657
Acronym / sponsor ID: FGCL-SM4592-017
Conditions: Chronic Kidney Disease, Anemia
Keywords: Kidney, Chronic Kidney Disease, CKD, Stage 3 or 4 Chronic Kidney Disease, Renal, Anemia, Oral anemia treatment, Hemoglobin levels
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 117 participants (actual)
Lead sponsor: Kyntra BioIndustry (pharma, biotech, devices)
Collaborators: Astellas Pharma Inc
Study start: 1 Nov 2006 (actual)
Primary completion: 21 Jun 2010 (actual)
Study completion: 21 Jun 2010 (actual)
First posted: 29 Sep 2008 (estimated)
Results: Posted 19 Nov 2021

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 9

Arm	Type	Receives
Roxadustat 0.7 mg/kg BIW	Experimental	Drug: RoxadustatParticipants will receive roxadustat 0.7 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days.
Roxadustat 0.7 mg/kg TIW	Experimental	Drug: RoxadustatParticipants will receive roxadustat 0.7 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days.
Roxadustat 1.0 mg/kg BIW	Experimental	Drug: RoxadustatParticipants will receive roxadustat 1.0 mg/kg BIW orally with doses administered at least 72 hours apart for 29 days.
Roxadustat 1.0 mg/kg TIW	Experimental	Drug: RoxadustatParticipants will receive roxadustat 1.0 mg/kg TIW orally with doses administered at least 48 hours apart for 26 days.
Roxadustat 1.5 mg/kg BIW	Experimental	Drug: RoxadustatParticipants will receive roxadustat 1.5 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days.
Roxadustat 1.5 mg/kg TIW	Experimental	Drug: RoxadustatParticipants will receive roxadustat 1.5 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days.
Roxadustat 2.0 mg/kg BIW	Experimental	Drug: RoxadustatParticipants will receive roxadustat 2.0 mg/kg BIW orally with doses administered at least 68 hours apart for 29 days.
Roxadustat 2.0 mg/kg TIW	Experimental	Drug: RoxadustatParticipants will receive roxadustat 2.0 mg/kg TIW orally with doses administered at least 46 hours apart for 26 days.
Placebo	Placebo comparator	Drug: PlaceboParticipants will receive placebo orally, matching to the roxadustat dose, number of days per week, and duration.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

18 to 80 years of age. Participants aged over 75 years but otherwise meet all other participant selection criteria will be evaluated on a case-by-case basis and can be included in this study, per discretion of Sponsor's physician representative such as medical monitor or clinical leader.
Chronic Kidney Disease Stage 3 or 4 with hemoglobin <11.0 grams (g)/deciliter (dL).
Normal iron studies.
Normal folate and vitamin B12 levels.
Liver function tests within normal limits at screening.

Key exclusion criteria (23 listed)

Seropositive for HIV.
History of chronic liver disease.
History of polycystic kidney disease (PKD).
Uncontrolled hypertension (diastolic BP >110 millimeter of mercury (mmHg) or systolic BP >170 mmHg at screening).
New York Heart Association Class III or IV congestive heart failure.

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
RoxadustatAlso: FG-4592Capsule	Drug	Roxadustat 0.7 mg/kg BIW, Roxadustat 0.7 mg/kg TIW, Roxadustat 1.0 mg/kg BIW, Roxadustat 1.0 mg/kg TIW, Roxadustat 1.5 mg/kg BIW, Roxadustat 1.5 mg/kg TIW, Roxadustat 2.0 mg/kg BIW, Roxadustat 2.0 mg/kg TIW
PlaceboCapsule	Drug	Placebo

Primary outcome

Primary Safety Outcome Measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Treatment Discontinuation (Parts 1 and 2 Combined)
Time frame: Baseline up to Week 16 (End of Study (EoS])
An adverse event (AE) was any untoward medical event in a participant who received study drug whether or not the event is considered drug related. TEAEs defined as an AE beginning after first dose of study drug until 28 days after last dose of study drug or existing AEs that worsened after first dose of study drug until the participant's last study visit. Severe AEs defined as incapacitating, inability to perform usual activities. Drug-related TEAEs defined as TEAEs with possible, probable, or definite relationship to study drug. Serious AE criteria included death, life-threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed here. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Co-Primary Efficacy Outcome Measure: Change From Baseline in Hb at Day 26-29 (End of Treatment)
Time frame: Baseline, End of Treatment (EoT) (Day 26 for TIW Dosing or Day 29 for BIW Dosing)
Mean Hb change from baseline was analyzed by treatment group and study visit. Baseline was defined as the mean of last 3 available values prior to the first dose.
Co-Primary Efficacy Outcome Measure: Change From Baseline in Hb at Week 8 (2 Weeks of Follow Up)
Time frame: Baseline, Week 8 (2 Weeks of Follow Up)
Mean Hb change from baseline was analyzed by treatment group and study visit. Baseline is defined as the mean of last 3 available values prior to the first dose.

4 secondary outcomes

Number of Participants With a Hemoglobin Response (Not Due to a RBC Transfusion or IV Iron Supplementation During Treatment)
Time frame: Baseline up to Day 26-29 (EoT), up to Week 8 (2 weeks of follow up), and up to Week 16 (EoS, 4 weeks of follow up)
Plasma Roxadustat Concentration (Part 2)
Time frame: Predose on Days 3 (TIW dose groups) or 4 (BIW dose groups), 8, 15, 22, and 26 (TIW dose groups) or 29 (BIW dose groups)
Change From Baseline in Plasma Erythropoietin in Part 1 Participants at Day 26 or Day 29
Time frame: Baseline (Day 1), 1, 2, 3, 4, 6, 8, 12, 18, 24, 48, and 72 hours on Day 26 (TIW Dosing) or Day 29 (BIW Dosing)
Change From Baseline in Plasma Erythropoietin in Part 2 Participants at 4, 8, 12, and 24 Hours on Day 1
Time frame: Baseline, 4, 8, 12, and 24 hours on Day 1

Results and safety

Results posted to the registry on 19 Nov 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Roxadustat 0.7 Milligrams/Kilograms (mg/kg) BIW	0	0
Roxadustat 0.7 mg/kg TIW	0	0
Roxadustat 1.0 mg/kg BIW	12	8
Roxadustat 1.0 mg/kg TIW	10	4
Roxadustat 1.5 mg/kg BIW	0	0
Roxadustat 1.5 mg/kg TIW	0	0
Roxadustat 2.0 mg/kg BIW	1	0
Roxadustat 2.0 mg/kg TIW	2	1
Placebo	10	9

Primary outcome: Primary Safety Outcome Measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Treatment Discontinuation (Parts 1 and 2 Combined)

Time frame: Baseline up to Week 16 (End of Study (EoS]). Count of participants. Unit: Participants

Measure	Roxadustat 0.7 mg/kg BIW n = 10	Roxadustat 0.7 mg/kg TIW n = 13	Roxadustat 1.0 mg/kg BIW n = 12	Roxadustat 1.0 mg/kg TIW n = 9	Roxadustat 1.5 mg/kg BIW n = 10	Roxadustat 1.5 mg/kg TIW n = 11	Roxadustat 2.0 mg/kg BIW n = 11	Roxadustat 2.0 mg/kg TIW n = 12	Placebo n = 28
Any TEAEs	3	9	7	5	9	7	7	5	13
Serious TEAEs	0	4	0	0	0	0	0	0	1
Severe TEAEs	0	3	1	0	0	1	1	0	1
Drug-Related TEAEs	1	2	2	1	3	3	3	1	3
TEAEs Leading to Treatment Discontinuation	0	0	0	1	0	0	1	0	1

Population analysed: Part 1 and Part 2 Safety Population: Participants who received at least 1 dose of study drug.

Primary outcome: Co-Primary Efficacy Outcome Measure: Change From Baseline in Hb at Day 26-29 (End of Treatment)

Time frame: Baseline, End of Treatment (EoT) (Day 26 for TIW Dosing or Day 29 for BIW Dosing). Mean (Standard Deviation). Unit: g/dL

Measure	Roxadustat 0.7 mg/kg BIW n = 10	Roxadustat 0.7 mg/kg TIW n = 12	Roxadustat 1.0 mg/kg BIW n = 5	Roxadustat 1.0 mg/kg TIW n = 5	Roxadustat 1.5 mg/kg BIW n = 10	Roxadustat 1.5 mg/kg TIW n = 11	Roxadustat 2.0 mg/kg BIW n = 9	Roxadustat 2.0 mg/kg TIW n = 11	Placebo n = 23
Baseline	10.32 (0.678)	10.03 (0.709)	9.18 (0.600)	10.35 (0.849)	10.28 (0.551)	10.08 (0.650)	9.97 (0.430)	9.93 (0.806)	10.10 (0.616)
Change at Day 26-29	0.25 (0.849)	0.60 (0.756)	0.44 (0.781)	0.21 (1.016)	1.22 (1.112)	1.65 (1.033)	1.35 (0.577)	1.75 (1.200)	-0.05 (0.500)

Roxadustat 0.7 mg/kg BIW vs Placebo: p = 0.2073, t-test, 2 sided
Roxadustat 0.7 mg/kg TIW vs Placebo: p = 0.0046, t-test, 2 sided
Roxadustat 1.0 mg/kg BIW vs Placebo: p = 0.0860, t-test, 2 sided

Population analysed: Part 1 and Part 2 EE Population: Participants who were anemic at baseline (Hb ≤11.0 g/dL and were in study treatment for at least 2.5 weeks with corresponding Hb values. Last-observation-carried-forward (LOCF) method was used to impute missing values.

Primary outcome: Co-Primary Efficacy Outcome Measure: Change From Baseline in Hb at Week 8 (2 Weeks of Follow Up)

Time frame: Baseline, Week 8 (2 Weeks of Follow Up). Mean (Standard Deviation). Unit: g/dL

Measure	Roxadustat 0.7 mg/kg BIW n = 10	Roxadustat 0.7 mg/kg TIW n = 12	Roxadustat 1.0 mg/kg BIW n = 5	Roxadustat 1.0 mg/kg TIW n = 5	Roxadustat 1.5 mg/kg BIW n = 10	Roxadustat 1.5 mg/kg TIW n = 11	Roxadustat 2.0 mg/kg BIW n = 9	Roxadustat 2.0 mg/kg TIW n = 11	Placebo n = 23
Baseline	10.32 (0.678)	10.03 (0.709)	9.18 (0.600)	10.35 (0.849)	10.28 (0.551)	10.08 (0.650)	9.97 (0.430)	9.93 (0.806)	10.10 (0.616)
Change at Week 8	0.59 (0.808)	0.24 (0.846)	0.50 (0.356)	0.05 (1.435)	0.79 (0.916)	1.31 (0.743)	1.21 (0.656)	1.52 (0.815)	0.04 (0.684)

Roxadustat 0.7 mg/kg BIW vs Placebo: p = 0.0507, t-test, 2 sided
Roxadustat 0.7 mg/kg TIW vs Placebo: p = 0.4502, t-test, 2 sided
Roxadustat 1.0 mg/kg BIW vs Placebo: p = 0.1603, t-test, 2 sided

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline up to Week 16 (EoS). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Roxadustat 0.7 mg/kg BIW	0 of 10 (0%)	3 of 10 (30%)	Not reported
Roxadustat 0.7 mg/kg TIW	4 of 13 (30.8%)	9 of 13 (69.2%)	Not reported
Roxadustat 1.0 mg/kg BIW	0 of 12 (0%)	7 of 12 (58.3%)	Not reported
Roxadustat 1.0 mg/kg TIW	0 of 9 (0%)	5 of 9 (55.6%)	Not reported
Roxadustat 1.5 mg/kg BIW	0 of 10 (0%)	9 of 10 (90%)	Not reported
Roxadustat 1.5 mg/kg TIW	0 of 11 (0%)	7 of 11 (63.6%)	Not reported
Roxadustat 2.0 mg/kg BIW	0 of 11 (0%)	7 of 11 (63.6%)	Not reported
Roxadustat 2.0 mg/kg TIW	0 of 12 (0%)	5 of 12 (41.7%)	Not reported
Placebo	1 of 28 (3.6%)	12 of 28 (42.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36005278Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2.
Derived from this study: PubMed 26238121Besarab A, Provenzano R, Hertel J, Zabaneh R, Klaus SJ, Lee T, Leong R, Hemmerich S, Yu KH, Neff TB. Randomized placebo-controlled dose-ranging and pharmacodynamics study of roxadustat (FG-4592) to treat anemia in nondialysis-dependent chronic kidney disease (NDD-CKD) patients. Nephrol Dial Transplant. 2015 Oct;30(10):1665-73. doi: 10.1093/ndt/gfv302. Epub 2015 Aug 3.

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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.

The record lists no contact. Use the official record to reach the sponsor.

34 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Roxadustat in people with Chronic Kidney Disease and Anemia, run by Kyntra Bio at 34 sites in United States.

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 9 inclusion and 23 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 19 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in United States. 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 19 Nov 2021). 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?

Primary Safety Outcome Measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Severe TEAEs, Drug-Related TEAEs, and TEAEs Leading to Treatment Discontinuation (Parts 1 and 2 Combined) (time frame: Baseline up to Week 16 (End of Study (EoS])). The study lists 3 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 NCT00761657, which also lists 2 linked publications.

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 19 Nov 2021.