A Phase 2 Study to Evaluate the Safety and Efficacy of CTP-499 in Type 2 Diabetic Nephropathy Patients
NCT ID: NCT01487109
Last Updated: 2021-08-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
170 participants
INTERVENTIONAL
2012-01-31
2015-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
matching placebo tablets
Placebo
Matching placebo tablet
CTP-499
600 mg tablet
CTP-499
600 mg tablet twice daily
Interventions
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CTP-499
600 mg tablet twice daily
Placebo
Matching placebo tablet
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Concert Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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LuAnn Sabounjian
Role: STUDY_DIRECTOR
Concert Pharmaceuticals
Locations
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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
Chula Vista, California, United States
SC Clinical Research
Garden Grove, California, United States
Premiere Clinical Research
Lakewood, California, United States
Long Beach Center for Clinical Research
Long Beach, California, United States
Premiere 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
Desert Oasis Healthcare Medical Group
Palm Springs, California, United States
Apex Research of Riverside
Riverside, California, United States
River City Clinical Research
Sacramento, California, United States
California Institute of Renal Research
San Diego, California, United States
Samsun Clinic
Santa Barbara, California, United States
Orange County Research Center
Tustin, California, United States
Infosphere Clinical Research
West Hills, California, United States
Creekside Endocrine Associates
Denver, Colorado, United States
Palm Spring Research Institute
Hialeah, Florida, United States
San Marcus Research Clinic, Inc.
Miami, Florida, United States
Advanced Pharma CR
Miami, Florida, United States
Ormond Medical Arts Pharmaceutical Research
Ormond Beach, Florida, United States
Clincal Research of Central Florida
Winter Haven, Florida, United States
River Birch Research Alliance
Blue Ridge, Georgia, United States
Apex Medical Research
Chicago, Illinois, United States
University of Chicago Medical Center
Chicago, Illinois, United States
American Health Network of IN
Avon, Indiana, United States
American Healthcare Network of Indiana
Greenfield, Indiana, United States
Medstar Health Research Institute
Hyattsville, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Harvard Medical School Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Apex Medical Research MI
Flint, Michigan, United States
Clinical Research Consultants (MO)
Kansas City, Missouri, United States
The Rogosin Institute
New York, New York, United States
Clinical Research Development Associates (NY)
Rosedale, New York, United States
University of North Carolina School of Medicine
Chapel Hill, North Carolina, United States
Clinical Research Limited
Canton, Ohio, United States
Lynn Institute of Norman
Norman, Oklahoma, United States
C.S.R.A. Renal Services
Aiken, South Carolina, United States
Pharmacorp Clinical Trials
Charleston, South Carolina, United States
Mountain View Clinical Research
Greer, South Carolina, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Millenium Clinical Research
Houston, Texas, United States
Research Across America
Houston, Texas, United States
Renal Associates
San Antonio, Texas, United States
Panacea Clinical Research
San Antonio, Texas, United States
Cetero
San Antonio, Texas, United States
Multicare Research Institute (WA)
Tacoma, Washington, United States
Countries
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Other Identifiers
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CP505.2001
Identifier Type: -
Identifier Source: org_study_id
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