A Phase 2 Study to Evaluate the Safety and Efficacy of CTP-499 in Type 2 Diabetic Nephropathy Patients
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
1 other identifier
interventional
170
1 country
49
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 type-2-diabetes-mellitus
Started Jan 2012
Longer than P75 for phase_2 type-2-diabetes-mellitus
49 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 5, 2011
CompletedFirst Posted
Study publicly available on registry
December 7, 2011
CompletedStudy Start
First participant enrolled
January 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedAugust 16, 2021
July 1, 2014
3 years
December 5, 2011
August 6, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To assess the change in urinary albumin to creatinine ratio
Weeks 16, 20, 24
Study Arms (2)
Placebo
PLACEBO COMPARATORmatching placebo tablets
CTP-499
ACTIVE COMPARATOR600 mg tablet
Interventions
Eligibility Criteria
You may qualify if:
- 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%
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (49)
Agave Clinical Research
Tempe, Arizona, 85282, United States
Harrisburg Family Medical Center
Harrisburg, Arkansas, 72432, United States
Arkansas Primary Care Clinic
Little Rock, Arkansas, 72204, United States
Providence Clinical Research
Burbank, California, 91505, United States
California Institute of Renal Research
Chula Vista, California, 91910, United States
SC Clinical Research
Garden Grove, California, 92844, United States
Premiere Clinical Research
Lakewood, California, 90712, United States
Long Beach Center for Clinical Research
Long Beach, California, 90806, United States
Premiere Clinical Research
Long Beach, California, 90807, United States
UCLA Kidney Transplant Research
Los Angeles, California, 90024, United States
David Geffen School of Medicine Division of Nephrology
Los Angeles, California, 90095, United States
Desert Oasis Healthcare Medical Group
Palm Springs, California, 92262, United States
Apex Research of Riverside
Riverside, California, 92505, United States
River City Clinical Research
Sacramento, California, 95816, United States
California Institute of Renal Research
San Diego, California, 92123, United States
Samsun Clinic
Santa Barbara, California, 93110, United States
Orange County Research Center
Tustin, California, 92780, United States
Infosphere Clinical Research
West Hills, California, 91307, United States
Creekside Endocrine Associates
Denver, Colorado, 80209, United States
Palm Spring Research Institute
Hialeah, Florida, 33012, United States
San Marcus Research Clinic, Inc.
Miami, Florida, 33015, United States
Advanced Pharma CR
Miami, Florida, 33136, United States
Ormond Medical Arts Pharmaceutical Research
Ormond Beach, Florida, 32174, United States
Clincal Research of Central Florida
Winter Haven, Florida, 33880, United States
River Birch Research Alliance
Blue Ridge, Georgia, 30513, United States
Apex Medical Research
Chicago, Illinois, 60616, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
American Health Network of IN
Avon, Indiana, 46123, United States
American Healthcare Network of Indiana
Greenfield, Indiana, 46140, United States
Medstar Health Research Institute
Hyattsville, Maryland, 20782, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Harvard Medical School Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Apex Medical Research MI
Flint, Michigan, 48504, United States
Clinical Research Consultants (MO)
Kansas City, Missouri, 64111, United States
The Rogosin Institute
New York, New York, 10021, United States
Clinical Research Development Associates (NY)
Rosedale, New York, 11422, United States
University of North Carolina School of Medicine
Chapel Hill, North Carolina, 27599, United States
Clinical Research Limited
Canton, Ohio, 44718, United States
Lynn Institute of Norman
Norman, Oklahoma, 73069, United States
C.S.R.A. Renal Services
Aiken, South Carolina, 29801, United States
Pharmacorp Clinical Trials
Charleston, South Carolina, 29412, United States
Mountain View Clinical Research
Greer, South Carolina, 29651, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Millenium Clinical Research
Houston, Texas, 77054, United States
Research Across America
Houston, Texas, 77054, United States
Renal Associates
San Antonio, Texas, 78215, United States
Panacea Clinical Research
San Antonio, Texas, 78228, United States
Cetero
San Antonio, Texas, 78229, United States
Multicare Research Institute (WA)
Tacoma, Washington, 98405, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
LuAnn Sabounjian
Concert Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 5, 2011
First Posted
December 7, 2011
Study Start
January 1, 2012
Primary Completion
January 1, 2015
Study Completion
January 1, 2015
Last Updated
August 16, 2021
Record last verified: 2014-07