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

• Status: Completed
• Trial end date: 2015-01-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Concert Pharmaceuticals

Criteria

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