A Phase 2 Study to Evaluate the Safety and Efficacy of CTP-499 in Type 2 Diabetic Nephropathy Patients
- Conditions
- Type 2 Diabetes MellitusChronic Kidney Disease
- Interventions
- Drug: Placebo
- Registration Number
- NCT01487109
- Lead Sponsor
- Concert Pharmaceuticals
- Brief Summary
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).
- Detailed Description
There are two parts to this study, each part includes double-blind treatment with either CTP-499 or placebo. Part 1 will evaluate the safety and efficacy of treatment with CTP-499 twice daily for 24 weeks. Part 2 will evaluate the effects of longer term dosing for an additional 24 weeks. Following Part 2, patients will be allowed to participate in an Open Label extension with CTP-499 for a period of an additional 48 weeks.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 170
- Male or female 18 years or older
- Patient diagnosed with Type 2 diabetes mellitus and chronic kidney disease
- On a stable regimen of ACE inhibitors and/or ARB drugs for a minimum of 4 weeks
- Not expected to start dialysis for one year
- Patient has blood pressure less than or equal to 145/90 mm Hg
- Patient has UACR greater than or equal to 200 mg/g if male and 300 mg/g if female but not more than 5000 mg/g
- Patient has glycosylated hemoglobin A1c less than or equal to 10.5%
- Patient has concurrent condition such as uncontrolled inflammatory disease, acute infection or other unstable illnesses
- Patient has a history of allergy or sensitivity to pentoxifylline or methylxanthines
- Patient has acute, active and/or unstable renal impairment or has been hospitalized for acute renal failure within the previous year
- Patient has active malignancy or history of neoplastic disease
- Patient has a QTc interval greater than 450 milliseconds
- Patient has ALT or AST greater than 3 times the upper limit of normal or a potassium greater than or equal to 5.5mEq/L at screening
- Patient is breast feeding or pregnant
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo matching placebo tablets CTP-499 CTP-499 600 mg tablet
- Primary Outcome Measures
Name Time Method To assess the change in urinary albumin to creatinine ratio Weeks 16, 20, 24
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (47)
Agave Clinical Research
🇺🇸Tempe, Arizona, United States
Providence Clinical Research
🇺🇸Burbank, California, United States
David Geffen School of Medicine Division of Nephrology
🇺🇸Los Angeles, California, United States
Apex Research of Riverside
🇺🇸Riverside, California, United States
Orange County Research Center
🇺🇸Tustin, California, United States
Palm Spring Research Institute
🇺🇸Hialeah, Florida, United States
Advanced Pharma CR
🇺🇸Miami, Florida, United States
Apex Medical Research
🇺🇸Chicago, Illinois, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Harvard Medical School Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Apex Medical Research MI
🇺🇸Flint, Michigan, United States
Panacea Clinical Research
🇺🇸San Antonio, Texas, United States
Cetero
🇺🇸San Antonio, Texas, United States
Medstar Health Research Institute
🇺🇸Hyattsville, Maryland, United States
Clincal Research of Central Florida
🇺🇸Winter Haven, Florida, United States
University of Chicago Medical Center
🇺🇸Chicago, Illinois, United States
American Healthcare Network of Indiana
🇺🇸Greenfield, Indiana, United States
Clinical Research Development Associates (NY)
🇺🇸Rosedale, New York, United States
Clinical Research Limited
🇺🇸Canton, Ohio, United States
Lynn Institute of Norman
🇺🇸Norman, Oklahoma, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Mountain View Clinical Research
🇺🇸Greer, South Carolina, United States
Renal Associates
🇺🇸San Antonio, Texas, United States
C.S.R.A. Renal Services
🇺🇸Aiken, South Carolina, United States
California Institute of Renal Research
🇺🇸San Diego, California, United States
SC Clinical Research
🇺🇸Garden Grove, California, United States
Desert Oasis Healthcare Medical Group
🇺🇸Palm Springs, California, United States
Ormond Medical Arts Pharmaceutical Research
🇺🇸Ormond Beach, Florida, United States
Premiere Clinical Research
🇺🇸Long Beach, California, United States
Arkansas Primary Care Clinic
🇺🇸Little Rock, Arkansas, United States
Harrisburg Family Medical Center
🇺🇸Harrisburg, Arkansas, United States
San Marcus Research Clinic, Inc.
🇺🇸Miami, Florida, United States
Samsun Clinic
🇺🇸Santa Barbara, California, United States
River Birch Research Alliance
🇺🇸Blue Ridge, Georgia, United States
Millenium Clinical Research
🇺🇸Houston, Texas, United States
Research Across America
🇺🇸Houston, Texas, United States
American Health Network of IN
🇺🇸Avon, Indiana, United States
Long Beach Center for Clinical Research
🇺🇸Long Beach, California, United States
UCLA Kidney Transplant Research
🇺🇸Los Angeles, California, United States
Infosphere Clinical Research
🇺🇸West Hills, California, United States
The Rogosin Institute
🇺🇸New York, New York, United States
Multicare Research Institute (WA)
🇺🇸Tacoma, Washington, United States
Creekside Endocrine Associates
🇺🇸Denver, Colorado, United States
University of North Carolina School of Medicine
🇺🇸Chapel Hill, North Carolina, United States
Pharmacorp Clinical Trials
🇺🇸Charleston, South Carolina, United States
River City Clinical Research
🇺🇸Sacramento, California, United States
Clinical Research Consultants (MO)
🇺🇸Kansas City, Missouri, United States