A Study to Evaluate the Safety and Efficacy of CCX140-B in Subjects With Diabetic Nephropathy
NCT ID: NCT01447147
Last Updated: 2025-02-27
Study Results
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Basic Information
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COMPLETED
PHASE2
332 participants
INTERVENTIONAL
2011-10-31
2014-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo (Group A)
Placebo
Placebo capsules once daily
CCX140-B (Group B)
CCX140-B
CCX140-B capsules once daily (Group B)
CCX140-B (Group C)
CCX140-B
CCX140-B capsules once daily (Group C)
Interventions
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Placebo
Placebo capsules once daily
CCX140-B
CCX140-B capsules once daily (Group B)
CCX140-B
CCX140-B capsules once daily (Group C)
Eligibility Criteria
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Inclusion 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
Exclusion Criteria
* 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)
18 Years
75 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Antwerp, , Belgium
Brussels, , Belgium
Edegem, , Belgium
Ghent, , Belgium
Leuven, , Belgium
Liège, , Belgium
Roeselare, , Belgium
Beroun, , Czechia
Brno, , Czechia
Hlučín, , Czechia
Neratovice, , Czechia
Nový Jičín, , Czechia
NZdar Nad Sazavou, , Czechia
Pardubice, , Czechia
Prague, , Czechia
Přelouč, , Czechia
Rakovník, , Czechia
Slaný, , Czechia
Třebíč, , Czechia
Uherský Brod, , Czechia
Uničov, , Czechia
Berlin, , Germany
Bosenheim, , Germany
Cologne, , Germany
Deggingen, , Germany
Dresden, , Germany
Erlangen, , Germany
Hanover, , Germany
Heidelberg, , Germany
Heilbronn, , Germany
Hoyerswerda, , Germany
Munich, , Germany
Neuwied, , Germany
Nuremberg, , Germany
Pirna, , Germany
Potsdam, , Germany
Saarlouis, , Germany
Speyer, , Germany
Wiesbaden, , Germany
Baja, , Hungary
Balatonfüred, , Hungary
Békéscsaba, , Hungary
Budapest, , Hungary
Debrecen, , Hungary
Eger, , Hungary
Gyula, , Hungary
Hatvan, , Hungary
Kaposvár, , Hungary
Kisvárda, , Hungary
Sátoraljaújhely, , Hungary
Szekszard, Tolna, , Hungary
Szikszó, , Hungary
Bialystok, , Poland
Ciechanów, , Poland
Gdansk, , Poland
Grodzisk Mazowiecki, , Poland
Krakow, , Poland
Poznan, , Poland
Radom, , Poland
Rzeszów, , Poland
Szczecin, , Poland
Warsaw, , Poland
Wroclaw, , Poland
Bath, , United Kingdom
Belfast, , United Kingdom
Birmingham, , United Kingdom
Bristol, , United Kingdom
Chester, , United Kingdom
Coventry, , United Kingdom
Doncaster, , United Kingdom
Edmonton, , United Kingdom
Liverpool, , United Kingdom
Livingston, , United Kingdom
London, , United Kingdom
Londonderry, , United Kingdom
Manchester, , United Kingdom
Middlesbrough, , United Kingdom
Norfolk, , United Kingdom
Preston, , United Kingdom
Salford, , United Kingdom
Sheffield, , United Kingdom
Swansea, , United Kingdom
Welwyn Garden City, , United Kingdom
Countries
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References
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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.
Sullivan 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.
Other Identifiers
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CL005_140
Identifier Type: -
Identifier Source: org_study_id
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