PCS499 - Processa Pharmaceuticals
A phase 2 study to evaluate the safety and efficacy of CTP-499 in type 2 diabetic nephropathy patients (clinicaltrials.gov) - Dec 6, 2011 - P2, N=170; Not yet recruiting; New P2 trial 
New trial • Renal Disease
http://clinicaltrials.gov/ct2/show/NCT01487109
 
Dec 6, 2011
 
This study is not yet open for participant recruitment. Verified on December 2011 by Concert Pharmaceuticals First Received on December 5, 2011.   Last Updated on December 6, 2011   History of Changes Sponsor: Concert Pharmaceuticals Information provided by (Responsible Party): Concert Pharmaceuticals ClinicalTrials.gov Identifier: NCT01487109   Purpose This study is being conducted to evaluate the safety and efficacy of treatment with CTP-499 for 24 weeks in patients with chronic kidney disease, Type 2 diabetic nephropathy and who are currently receiving treatment with an angiotensin converting enzyme inhibitor (ACEI) and/or angiotensin II receptor blocker (ARB). Condition   Type 2 Diabetes Mellitus Chronic Kidney Disease Intervention Drug: CTP-499 Drug: Placebo Phase Phase II Study Type: Interventional Study Design: Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment Official Title: A Phase 2, Randomized, Double Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of CTP-499 in Type 2 Diabetic Nephropathy Patients Currently Treated With ACEI and/or ARB Therapy Resource links provided by NLM: Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus MedlinePlus related topics: Diabetes Diabetes Type 2 Diabetic Kidney Problems Kidney Failure U.S. FDA Resources  Further study details as provided by Concert Pharmaceuticals: Primary Outcome Measures: To assess the change in urinary albumin to creatinine ratio [ Time Frame: Weeks 16, 20, 24 ] [ Designated as safety issue: No ] Estimated Enrollment: 170 Study Start Date: January 2012 Estimated Study Completion Date: May 2013 Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)