--- title: A Study to Evaluate the Safety and Efficacy of CCX140-B in Subjects With Diabetic Nephropathy nct_id: NCT01447147 overall_status: COMPLETED phase: PHASE2 sponsor: Amgen study_type: INTERVENTIONAL primary_condition: Diabetic Nephropathy countries: Belgium, Czechia, Germany, Hungary, Poland, United Kingdom canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01447147.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01447147" ct_last_update_post_date: 2025-02-27 last_seen_at: "2026-05-12T06:43:07.085Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # A Study to Evaluate the Safety and Efficacy of CCX140-B in Subjects With Diabetic Nephropathy **Official Title:** A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of CCX140-B in Diabetic Nephropathy **NCT ID:** [NCT01447147](https://clinicaltrials.gov/study/NCT01447147) ## Key Facts - **Status:** COMPLETED - **Phase:** PHASE2 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 332 - **Lead Sponsor:** Amgen - **Conditions:** Diabetic Nephropathy, Type 2 Diabetes Mellitus - **Start Date:** 2011-10 - **Completion Date:** 2014-12 - **CT.gov Last Update:** 2025-02-27 ## Brief Summary 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. ## Eligibility - **Minimum age:** 18 Years - **Maximum age:** 75 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` Key Inclusion Criteria: * 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: * 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) ``` ## Arms - **Placebo (Group A)** (PLACEBO_COMPARATOR) - **CCX140-B (Group B)** (EXPERIMENTAL) - **CCX140-B (Group C)** (EXPERIMENTAL) ## Interventions - **Placebo** (DRUG) — Placebo capsules once daily - **CCX140-B** (DRUG) — CCX140-B capsules once daily (Group B) - **CCX140-B** (DRUG) — CCX140-B capsules once daily (Group C) ## Primary Outcomes - **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. ## Secondary Outcomes - **Change from baseline in first morning urinary albumin:creatinine ratio (ACR)** _(time frame: Up to 365 days)_ ## Locations (83) - 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 ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.maxAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.|antwerp||belgium` — added _(2026-05-12)_ - `locations.|brussels||belgium` — added _(2026-05-12)_ - `locations.|edegem||belgium` — added _(2026-05-12)_ - `locations.|ghent||belgium` — added _(2026-05-12)_ - `locations.|leuven||belgium` — added _(2026-05-12)_ - `locations.|liège||belgium` — added _(2026-05-12)_ - `locations.|roeselare||belgium` — added _(2026-05-12)_ - `locations.|beroun||czechia` — added _(2026-05-12)_ - `locations.|brno||czechia` — added _(2026-05-12)_ - `locations.|hlučín||czechia` — added _(2026-05-12)_ - `locations.|neratovice||czechia` — added _(2026-05-12)_ - `locations.|nový jičín||czechia` — added _(2026-05-12)_ - `locations.|nzdar nad sazavou||czechia` — added _(2026-05-12)_ - `locations.|pardubice||czechia` — added _(2026-05-12)_ - `locations.|prague||czechia` — added _(2026-05-12)_ - `locations.|přelouč||czechia` — added _(2026-05-12)_ - `locations.|rakovník||czechia` — added _(2026-05-12)_ - `locations.|slaný||czechia` — added _(2026-05-12)_ - `locations.|třebíč||czechia` — added _(2026-05-12)_ - `locations.|uherský brod||czechia` — added _(2026-05-12)_ - `locations.|uničov||czechia` — added _(2026-05-12)_ - `locations.|berlin||germany` — added _(2026-05-12)_ - `locations.|bosenheim||germany` — added _(2026-05-12)_ - `locations.|cologne||germany` — added _(2026-05-12)_ - `locations.|deggingen||germany` — added _(2026-05-12)_ - `locations.|dresden||germany` — added _(2026-05-12)_ - `locations.|erlangen||germany` — added _(2026-05-12)_ - `locations.|hanover||germany` — added _(2026-05-12)_ - `locations.|heidelberg||germany` — added _(2026-05-12)_ - `locations.|heilbronn||germany` — added _(2026-05-12)_ - `locations.|hoyerswerda||germany` — added _(2026-05-12)_ - `locations.|munich||germany` — added _(2026-05-12)_ - `locations.|neuwied||germany` — added _(2026-05-12)_ - `locations.|nuremberg||germany` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT01447147.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT01447147* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*