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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01487109
• Other study ID #: CP505.2001
• Status: Completed
• Phase: Phase 2
• Start date: January 2012
• Est. completion date: January 2015

Study information

• Verified date: July 2014
• Source: Concert Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Diabetes Mellitus, Type 2
• Diabetic Nephropathies
• Kidney Diseases
• Renal Insufficiency, Chronic
• Type 2 Diabetes Mellitus

Intervention

Drug:
• CTP-499
600 mg tablet twice daily
• Placebo
Matching placebo tablet

Locations

Country	Name	City	State
United States	C.S.R.A. Renal Services	Aiken	South Carolina
United States	American Health Network of IN	Avon	Indiana
United States	River Birch Research Alliance	Blue Ridge	Georgia
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Harvard Medical School Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Providence Clinical Research	Burbank	California
United States	Clinical Research Limited	Canton	Ohio
United States	University of North Carolina School of Medicine	Chapel Hill	North Carolina
United States	Pharmacorp Clinical Trials	Charleston	South Carolina
United States	Apex Medical Research	Chicago	Illinois
United States	University of Chicago Medical Center	Chicago	Illinois
United States	California Institute of Renal Research	Chula Vista	California
United States	Creekside Endocrine Associates	Denver	Colorado
United States	Apex Medical Research MI	Flint	Michigan
United States	SC Clinical Research	Garden Grove	California
United States	American Healthcare Network of Indiana	Greenfield	Indiana
United States	Mountain View Clinical Research	Greer	South Carolina
United States	Harrisburg Family Medical Center	Harrisburg	Arkansas
United States	Palm Spring Research Institute	Hialeah	Florida
United States	Millenium Clinical Research	Houston	Texas
United States	Research Across America	Houston	Texas
United States	Medstar Health Research Institute	Hyattsville	Maryland
United States	Clinical Research Consultants (MO)	Kansas City	Missouri
United States	Premiere Clinical Research	Lakewood	California
United States	Arkansas Primary Care Clinic	Little Rock	Arkansas
United States	Long Beach Center for Clinical Research	Long Beach	California
United States	Premiere Clinical Research	Long Beach	California
United States	David Geffen School of Medicine Division of Nephrology	Los Angeles	California
United States	UCLA Kidney Transplant Research	Los Angeles	California
United States	Advanced Pharma CR	Miami	Florida
United States	San Marcus Research Clinic, Inc.	Miami	Florida
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	The Rogosin Institute	New York	New York
United States	Lynn Institute of Norman	Norman	Oklahoma
United States	Ormond Medical Arts Pharmaceutical Research	Ormond Beach	Florida
United States	Desert Oasis Healthcare Medical Group	Palm Springs	California
United States	Apex Research of Riverside	Riverside	California
United States	Clinical Research Development Associates (NY)	Rosedale	New York
United States	River City Clinical Research	Sacramento	California
United States	Cetero	San Antonio	Texas
United States	Panacea Clinical Research	San Antonio	Texas
United States	Renal Associates	San Antonio	Texas
United States	California Institute of Renal Research	San Diego	California
United States	Samsun Clinic	Santa Barbara	California
United States	Multicare Research Institute (WA)	Tacoma	Washington
United States	Agave Clinical Research	Tempe	Arizona
United States	Orange County Research Center	Tustin	California
United States	Infosphere Clinical Research	West Hills	California
United States	Clincal Research of Central Florida	Winter Haven	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Concert Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the change in urinary albumin to creatinine ratio		Weeks 16, 20, 24