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

Phase 2

Completed

• Conditions: Type 2 Diabetes Mellitus; Chronic Kidney Disease
• Interventions: Drug: Placebo; Drug: CTP-499

• Registration Number: NCT01487109
• Lead Sponsor: Concert Pharmaceuticals

Brief 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).

Detailed 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.

Study Timeline

• Study First Submitted: 2011-12-05
• Study First Submitted QC: 2011-12-06
• Study First Posted: 2011-12-07
• Study Start: 2012-01
• Status Verified: 2014-07
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Disposition First Submitted: 2021-06-02
• Disposition First Submitted QC: 2021-06-02
• Disposition First Posted: 2021-06-10
• Last Update Submitted: 2021-08-06
• Last Update Posted: 2021-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 170

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	matching placebo tablets
CTP-499	CTP-499	600 mg tablet

Primary Outcome Measures

Name	Time	Method
To assess the change in urinary albumin to creatinine ratio	Weeks 16, 20, 24

Trial Locations

Locations (47)

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; 🇺🇸 San Diego, California, United States

SC Clinical Research; 🇺🇸 Garden Grove, California, United States

Premiere Clinical Research; 🇺🇸 Long Beach, California, United States

Long Beach Center for 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

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