A Phase 2 Study to Evaluate the Safety and Efficacy of CTP-499 in Type 2 Diabetic Nephropathy Patients

Completed · Phase 2 · Has a placebo group

Conditions studied: Type 2 Diabetes Mellitus, Chronic Kidney Disease

In brief

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).

Key facts

Study ID

NCT01487109

Run by

Concert Pharmaceuticals

People needed

170

Starts

2012-01-01

Expected to finish

2015-01-01

Last updated by the study team

2021-08-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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%

You may not qualify if…

• 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

Where it is running

• Agave Clinical Research — Tempe, Arizona, United States
• Harrisburg Family Medical Center — Harrisburg, Arkansas, United States
• Arkansas Primary Care Clinic — Little Rock, Arkansas, United States
• Providence Clinical Research — Burbank, California, United States
• California Institute of Renal Research — Chula Vista, California, United States
• SC Clinical Research — Garden Grove, California, United States
• Premiere Clinical Research — Lakewood, California, United States
• Long Beach Center for Clinical Research — Long Beach, California, United States
• Premiere Clinical Research — Long Beach, California, United States
• UCLA Kidney Transplant Research — Los Angeles, California, United States
• David Geffen School of Medicine Division of Nephrology — Los Angeles, California, United States
• Desert Oasis Healthcare Medical Group — Palm Springs, California, United States
• Apex Research of Riverside — Riverside, California, United States
• River City Clinical Research — Sacramento, California, United States
• California Institute of Renal Research — San Diego, California, United States
• Samsun Clinic — Santa Barbara, California, United States
• Orange County Research Center — Tustin, California, United States
• Infosphere Clinical Research — West Hills, California, United States
• Creekside Endocrine Associates — Denver, Colorado, United States
• Palm Spring Research Institute — Hialeah, Florida, United States
• San Marcus Research Clinic, Inc. — Miami, Florida, United States
• Advanced Pharma CR — Miami, Florida, United States
• Ormond Medical Arts Pharmaceutical Research — Ormond Beach, Florida, United States
• Clincal Research of Central Florida — Winter Haven, Florida, United States
• River Birch Research Alliance — Blue Ridge, Georgia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.