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
| Verified date | July 2014 |
| Source | Concert Pharmaceuticals |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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).
| 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 |
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Concert Pharmaceuticals |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | To assess the change in urinary albumin to creatinine ratio | Weeks 16, 20, 24 |
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