This trial is active, not recruiting.

Conditions type 2 diabetes mellitus, chronic kidney disease
Treatments ctp-499, placebo
Phase phase 2
Sponsor Concert Pharmaceuticals
Start date January 2012
End date January 2015
Trial size 170 participants
Trial identifier NCT01487109, CP505.2001


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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
(Placebo Comparator)
matching placebo tablets
Matching placebo tablet
(Active Comparator)
600 mg tablet
600 mg tablet twice daily

Primary Outcomes

To assess the change in urinary albumin to creatinine ratio
time frame: Weeks 16, 20, 24

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - 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% Exclusion Criteria: - 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

Additional Information

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
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2014.
Information provided to ClinicalTrials.gov by Concert Pharmaceuticals.