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

Concert Pharmaceuticals

Status and phase

Completed

Phase 2

Conditions

Chronic Kidney Disease

Type 2 Diabetes Mellitus

Treatments

Drug: CTP-499

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01487109

CP505.2001

Details and patient eligibility

About

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).

Full 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.

Enrollment

170 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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