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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Type 2 Diabetes Mellitus, Chronic Kidney Disease

Intervention / Treatment
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* Drug: CTP-499
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>matching placebo tablets | Drug: Placebo<br>* Matching placebo tablet<br>|
| Active Comparator: CTP-499<br>600 mg tablet | Drug: CTP-499<br>* 600 mg tablet twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the change in urinary albumin to creatinine ratio |  | Weeks 16, 20, 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 diabetes, chronic kidney disease