Diabetic NephropathyPhase 2NCT01447147
A Study to Evaluate the Safety and Efficacy of CCX140-B in Subjects With Diabetic Nephropathy
A Phase 2 study testing CCX140-B in people with Diabetic Nephropathy and Type 2 Diabetes Mellitus, run by Amgen at 83 sites in 6 countries.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of treatment with CCX140-B in subjects with diabetic nephropathy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetic Nephropathy, Type 2 Diabetes Mellitus
- 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
- 332 participants
- Where
- 83 sitesin 6 countries
- Study dates
- Oct 2011to Dec 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Aged 18-75 years inclusive, with documented previously diagnosed type 2 diabetes mellitus (per American Diabetes Association [ADA] criteria)
- Residual albuminuria despite stable treatment with an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin receptor blocker (ARB) for at least 8 weeks prior to screening (Albumin:creatinine ratio [ACR] of 100 to 3000 mg/g creatinine, inclusive)
- Estimated glomerular filtration rate based on serum creatinine (eGFR, determined by Modification of Diet in Renal Disease [MDRD] equation) of ≥ 25 mL/min/1.73 m(2)
- Must be on a stable dose of an ACE inhibitor or ARB for at least 8 weeks prior to screening, but subjects must not be on both an ACE inhibitor and an ARB
- Hemoglobin A1c (HbA1c) > 6.0% but not > 10.0% and fasting plasma glucose less than 270 mg/dL at screening
Who cannot join
- Type 1 diabetes mellitus or history of diabetic ketoacidosis
- Previous renal transplant or known non-diabetic renal disease, except related to hypertension
- Undergone renal dialysis at any time in the past
- Received chronic (more than 7 days continuously) systemic glucocorticoid or other immunosuppressive treatment within 8 weeks of screening
- Use of bardoxolone, atrasentan or other endothelin antagonist within 8 weeks of screening
- Received chronic (more than 7 days continuously) non-steroidal anti-inflammatory drug (NSAID) treatment within 2 weeks of screening
- Cardiac failure (class III or IV), history of unstable angina, symptomatic coronary artery disease, myocardial infarction or stroke within 12 weeks of screening
- Poorly-controlled blood pressure (systolic blood pressure >155 or diastolic blood pressure >95, with blood pressure measured in the seated position after at least 5 minutes of rest)
Trial locations and contacts
83 sites in 6 countries.
83 sites in 6 countries
United Kingdom20 sites
Study site
Bath
Study site
Belfast
Study site
Birmingham
Study site
Bristol
Study site
Chester
Study site
Coventry
Study site
Doncaster
Study site
Edmonton
Study site
Liverpool
Study site
Livingston
Study site
London
Study site
Londonderry
Study site
Manchester
Study site
Middlesbrough
Study site
Norfolk
Study site
Preston
Study site
Salford
Study site
Sheffield
Study site
Swansea
Study site
Welwyn Garden City
Germany18 sites
Study site
Berlin
Study site
Bosenheim
Study site
Cologne
Study site
Deggingen
Study site
Dresden
Study site
Erlangen
Study site
Hanover
Study site
Heidelberg
Study site
Heilbronn
Study site
Hoyerswerda
Study site
Munich
Study site
Neuwied
Study site
Nuremberg
Study site
Pirna
Study site
Potsdam
Study site
Saarlouis
Study site
Speyer
Study site
Wiesbaden
Czechia14 sites
Study site
Beroun
Study site
Brno
Study site
Hlučín
Study site
Neratovice
Study site
Nový Jičín
Study site
NZdar Nad Sazavou
Study site
Pardubice
Study site
Prague
Study site
Přelouč
Study site
Rakovník
Study site
Slaný
Study site
Třebíč
Study site
Uherský Brod
Study site
Uničov
Hungary13 sites
Study site
Baja
Study site
Balatonfüred
Study site
Békéscsaba
Study site
Budapest
Study site
Debrecen
Study site
Eger
Study site
Gyula
Study site
Hatvan
Study site
Kaposvár
Study site
Kisvárda
Study site
Sátoraljaújhely
Study site
Szekszard, Tolna
Study site
Szikszó
Poland11 sites
Study site
Bialystok
Study site
Ciechanów
Study site
Gdansk
Study site
Grodzisk Mazowiecki
Study site
Krakow
Study site
Poznan
Study site
Radom
Study site
Rzeszów
Study site
Szczecin
Study site
Warsaw
Study site
Wroclaw
Belgium7 sites
Study site
Antwerp
Study site
Brussels
Study site
Edegem
Study site
Ghent
Study site
Leuven
Study site
Liège
Study site
Roeselare
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of CCX140-B in Diabetic Nephropathy
The purpose of this study is to evaluate the safety and efficacy of treatment with CCX140-B in subjects with diabetic nephropathy.
Read the detailed description
The primary objective of this study is to evaluate the safety and tolerability of CCX140-B in subjects with diabetic nephropathy based on subject incidence of adverse events.
The secondary objectives of this study include evaluation of the effect of CCX140-B on several measures of effectiveness commonly used in the evaluation of diabetes and renal medications.
Study acquired by Amgen and all disclosures were done by previous sponsor ChemoCentryx.
- Conditions
- Diabetic Nephropathy, Type 2 Diabetes Mellitus
- Being tested
- Placebo, CCX140-B
- Medical subject headings
- Diabetic Nephropathies, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo capsules once daily
CCX140-BDrug
CCX140-B capsules once daily (Group B)
CCX140-BDrug
CCX140-B capsules once daily (Group C)
| Study group | Role | What they receive |
|---|---|---|
| Placebo (Group A) | Placebo comparator | Not described Receives: Drug: Placebo |
| CCX140-B (Group B) | Experimental | Not described Receives: Drug: CCX140-B |
| CCX140-B (Group C) | Experimental | Not described Receives: Drug: CCX140-B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject incidence of adverse events
The primary objective of this study is to evaluate the safety and tolerability of CCX140-B in subjects with diabetic nephropathy.
Measured: Up to 365 days
Secondary outcomes (1)
Change from baseline in first morning urinary albumin:creatinine ratio (ACR)
Measured: Up to 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionAug 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetic NephropathyStudies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 332 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01447147
- Sponsor's protocol ID
- CL005_140
- Status last verified
- Feb 2025
- First submitted
- 4 Oct 2011
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
de Zeeuw D, Bekker P, Henkel E, Hasslacher C, Gouni-Berthold I, Mehling H, Potarca A, Tesar V, Heerspink HJ, Schall TJ; CCX140-B Diabetic Nephropathy Study Group. The effect of CCR2 inhibitor CCX140-B on residual albuminuria in patients with type 2 diabetes and nephropathy: a randomised trial. Lancet Diabetes Endocrinol. 2015 Sep;3(9):687-96. doi: 10.1016/S2213-8587(15)00261-2. Epub 2015 Aug 9.
PubMed 26268910Sullivan T, Miao Z, Dairaghi DJ, Krasinski A, Wang Y, Zhao BN, Baumgart T, Ertl LS, Pennell A, Seitz L, Powers J, Zhao R, Ungashe S, Wei Z, Boring L, Tsou CL, Charo I, Berahovich RD, Schall TJ, Jaen JC. CCR2 antagonist CCX140-B provides renal and glycemic benefits in diabetic transgenic human CCR2 knockin mice. Am J Physiol Renal Physiol. 2013 Nov 1;305(9):F1288-97. doi: 10.1152/ajprenal.00316.2013. Epub 2013 Aug 28.
PubMed 23986513
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of CCX140-B in Diabetic Nephropathy
- ClinicalTrials.gov ID
- NCT01447147
- Acronym / sponsor ID
- CL005_140
- Conditions
- Diabetic Nephropathy, Type 2 Diabetes Mellitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 332 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Aug 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 6 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and efficacy of treatment with CCX140-B in subjects with diabetic nephropathy.
Detailed description
The primary objective of this study is to evaluate the safety and tolerability of CCX140-B in subjects with diabetic nephropathy based on subject incidence of adverse events.
The secondary objectives of this study include evaluation of the effect of CCX140-B on several measures of effectiveness commonly used in the evaluation of diabetes and renal medications.
Study acquired by Amgen and all disclosures were done by previous sponsor ChemoCentryx.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo (Group A) | Placebo comparator | Drug: Placebo |
| CCX140-B (Group B) | Experimental | Drug: CCX140-B |
| CCX140-B (Group C) | Experimental | Drug: CCX140-B |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 18-75 years inclusive, with documented previously diagnosed type 2 diabetes mellitus (per American Diabetes Association [ADA] criteria)
- Residual albuminuria despite stable treatment with an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin receptor blocker (ARB) for at least 8 weeks prior to screening (Albumin:creatinine ratio [ACR] of 100 to 3000 mg/g creatinine, inclusive)
- Estimated glomerular filtration rate based on serum creatinine (eGFR, determined by Modification of Diet in Renal Disease [MDRD] equation) of ≥ 25 mL/min/1.73 m(2)
- Must be on a stable dose of an ACE inhibitor or ARB for at least 8 weeks prior to screening, but subjects must not be on both an ACE inhibitor and an ARB
- Hemoglobin A1c (HbA1c) > 6.0% but not > 10.0% and fasting plasma glucose less than 270 mg/dL at screening
Key exclusion criteria (8 listed)
- Type 1 diabetes mellitus or history of diabetic ketoacidosis
- Previous renal transplant or known non-diabetic renal disease, except related to hypertension
- Undergone renal dialysis at any time in the past
- Received chronic (more than 7 days continuously) systemic glucocorticoid or other immunosuppressive treatment within 8 weeks of screening
- Use of bardoxolone, atrasentan or other endothelin antagonist within 8 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 |
|---|---|---|
| PlaceboPlacebo capsules once daily | Drug | Placebo (Group A) |
| CCX140-BCCX140-B capsules once daily (Group B) | Drug | CCX140-B (Group B) |
| CCX140-BCCX140-B capsules once daily (Group C) | Drug | CCX140-B (Group C) |
Primary outcome
Subject incidence of adverse events
Time frame: Up to 365 days
The primary objective of this study is to evaluate the safety and tolerability of CCX140-B in subjects with diabetic nephropathy.
1 secondary outcome
Change from baseline in first morning urinary albumin:creatinine ratio (ACR)
Time frame: Up to 365 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- Derived from this study: PubMed 26268910de Zeeuw D, Bekker P, Henkel E, Hasslacher C, Gouni-Berthold I, Mehling H, Potarca A, Tesar V, Heerspink HJ, Schall TJ; CCX140-B Diabetic Nephropathy Study Group. The effect of CCR2 inhibitor CCX140-B on residual albuminuria in patients with type 2 diabetes and nephropathy: a randomised trial. Lancet Diabetes Endocrinol. 2015 Sep;3(9):687-96. doi: 10.1016/S2213-8587(15)00261-2. Epub 2015 Aug 9.
- Derived from this study: PubMed 23986513Sullivan T, Miao Z, Dairaghi DJ, Krasinski A, Wang Y, Zhao BN, Baumgart T, Ertl LS, Pennell A, Seitz L, Powers J, Zhao R, Ungashe S, Wei Z, Boring L, Tsou CL, Charo I, Berahovich RD, Schall TJ, Jaen JC. CCR2 antagonist CCX140-B provides renal and glycemic benefits in diabetic transgenic human CCR2 knockin mice. Am J Physiol Renal Physiol. 2013 Nov 1;305(9):F1288-97. doi: 10.1152/ajprenal.00316.2013. Epub 2013 Aug 28.
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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
83 sites in 6 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 Diabetic Nephropathy and Type 2 Diabetes Mellitus, run by Amgen at 83 sites in 6 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 5 inclusion and 8 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 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 83 sites in United Kingdom, Germany, Czechia, Hungary, Poland and 1 more country. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Subject incidence of adverse events (time frame: Up to 365 days). 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 NCT01447147, 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 27 Feb 2025.