A Study to Evaluate the Safety and Efficacy of CCX140-B in Subjects With Diabetic Nephropathy
A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of CCX140-B in Diabetic Nephropathy
1 other identifier
interventional
332
6 countries
83
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of treatment with CCX140-B in subjects with diabetic nephropathy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2011
Typical duration for phase_2
83 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 4, 2011
CompletedFirst Posted
Study publicly available on registry
October 6, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedFebruary 27, 2025
February 1, 2025
2.8 years
October 4, 2011
February 25, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Up to 365 days
Secondary Outcomes (1)
Change from baseline in first morning urinary albumin:creatinine ratio (ACR)
Up to 365 days
Study Arms (3)
Placebo (Group A)
PLACEBO COMPARATORCCX140-B (Group B)
EXPERIMENTALCCX140-B (Group C)
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (83)
Unknown Facility
Antwerp, Belgium
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Brussels, Belgium
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Edegem, Belgium
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Ghent, Belgium
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Leuven, Belgium
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Liège, Belgium
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Roeselare, Belgium
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Beroun, Czechia
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Brno, Czechia
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Hlučín, Czechia
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Neratovice, Czechia
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Nový Jičín, Czechia
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NZdar Nad Sazavou, Czechia
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Pardubice, Czechia
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Prague, Czechia
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Přelouč, Czechia
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Rakovník, Czechia
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Slaný, Czechia
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Třebíč, Czechia
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Uherský Brod, Czechia
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Uničov, Czechia
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Berlin, Germany
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Bosenheim, Germany
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Cologne, Germany
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Deggingen, Germany
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Dresden, Germany
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Erlangen, Germany
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Hanover, Germany
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Heidelberg, Germany
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Heilbronn, Germany
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Hoyerswerda, Germany
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Munich, Germany
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Neuwied, Germany
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Nuremberg, Germany
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Pirna, Germany
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Potsdam, Germany
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Saarlouis, Germany
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Speyer, Germany
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Wiesbaden, Germany
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Baja, Hungary
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Balatonfüred, Hungary
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Békéscsaba, Hungary
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Budapest, Hungary
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Debrecen, Hungary
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Eger, Hungary
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Gyula, Hungary
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Hatvan, Hungary
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Kaposvár, Hungary
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Kisvárda, Hungary
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Sátoraljaújhely, Hungary
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Szekszard, Tolna, Hungary
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Szikszó, Hungary
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Bialystok, Poland
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Ciechanów, Poland
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Gdansk, Poland
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Grodzisk Mazowiecki, Poland
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Krakow, Poland
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Poznan, Poland
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Radom, Poland
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Rzeszów, Poland
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Szczecin, Poland
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Warsaw, Poland
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Wroclaw, Poland
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Bath, United Kingdom
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Belfast, United Kingdom
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Birmingham, United Kingdom
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Bristol, United Kingdom
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Chester, United Kingdom
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Coventry, United Kingdom
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Doncaster, United Kingdom
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Edmonton, United Kingdom
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Liverpool, United Kingdom
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Livingston, United Kingdom
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London, United Kingdom
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Londonderry, United Kingdom
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Manchester, United Kingdom
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Middlesbrough, United Kingdom
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Norfolk, United Kingdom
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Preston, United Kingdom
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Salford, United Kingdom
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Sheffield, United Kingdom
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Swansea, United Kingdom
Unknown Facility
Welwyn Garden City, United Kingdom
Related Publications (2)
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.
PMID: 26268910DERIVEDSullivan 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.
PMID: 23986513DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MD
Amgen
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 4, 2011
First Posted
October 6, 2011
Study Start
October 1, 2011
Primary Completion
August 1, 2014
Study Completion
December 1, 2014
Last Updated
February 27, 2025
Record last verified: 2025-02