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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Concert Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01487109
First received: December 5, 2011
Last updated: July 8, 2014
Last verified: July 2014
  Purpose

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).


Condition Intervention Phase
Type 2 Diabetes Mellitus
Chronic Kidney Disease
Drug: CTP-499
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Concert Pharmaceuticals:

Primary Outcome Measures:
  • To assess the change in urinary albumin to creatinine ratio [ Time Frame: Weeks 16, 20, 24 ] [ Designated as safety issue: No ]

Estimated Enrollment: 170
Study Start Date: January 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
matching placebo tablets
Drug: Placebo
Matching placebo tablet
Active Comparator: CTP-499
600 mg tablet
Drug: CTP-499
600 mg tablet twice daily

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01487109

  Hide Study Locations
Locations
United States, Arizona
Agave Clinical Research
Tempe, Arizona, United States, 85282
United States, Arkansas
Harrisburg Family Medical Center
Harrisburg, Arkansas, United States, 72432
Arkansas Primary Care Clinic
Little Rock, Arkansas, United States, 72204
United States, California
Providence Clinical Research
Burbank, California, United States, 91505
California Institute of Renal Research
Chula Vista, California, United States, 91910
SC Clinical Research
Garden Grove, California, United States, 92844
Premiere Clinical Research
Lakewood, California, United States, 90712
Long Beach Center for Clinical Research
Long Beach, California, United States, 90806
Premiere Clinical Research
Long Beach, California, United States, 90807
UCLA Kidney Transplant Research
Los Angelas, California, United States, 90024
David Geffen School of Medicine Division of Nephrology
Los Angelas, California, United States, 90095
Desert Oasis Healthcare Medical Group
Palm Springs, California, United States, 92262
Apex Research of Riverside
Riverside, California, United States, 92505
River City Clinical Research
Sacramento, California, United States, 95816
California Institute of Renal Research
San Diego, California, United States, 92123
Samsun Clinic
Santa Barbara, California, United States, 93110
Orange County Research Center
Tustin, California, United States, 92780
Infosphere Clinical Research
West Hills, California, United States, 91307
United States, Colorado
Creekside Endocrine Associates
Denver, Colorado, United States, 80209
United States, Florida
Palm Spring Research Institute
Hialeah, Florida, United States, 33012
Advanced Pharma CR
Miami, Florida, United States, 33136
San Marcus Research Clinic, Inc.
Miami, Florida, United States, 33015
Ormond Medical Arts Pharmaceutical Research
Ormond Beach, Florida, United States, 32174
Clincal Research of Central Florida
Winter Haven, Florida, United States, 33880
United States, Georgia
River Birch Research Alliance
Blue Ridge, Georgia, United States, 30513
United States, Illinois
Apex Medical Research
Chicago, Illinois, United States, 60616
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
United States, Indiana
American Health Network of IN
Avon, Indiana, United States, 46123
American Healthcare Network of Indiana
Greenfield, Indiana, United States, 46140
United States, Maryland
Medstar Health Research Institute
Hyattsville, Maryland, United States, 20782
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Harvard Medical School Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Michigan
Apex Medical Research MI
Flint, Michigan, United States, 48504
United States, Missouri
Clinical Research Consultants (MO)
Kansas City, Missouri, United States, 64111
United States, New York
The Rogosin Institute
New York, New York, United States, 10021
Clinical Research Development Associates (NY)
Rosedale, New York, United States, 11422
United States, North Carolina
University of North Carolina School of Medicine
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
Clinical Research Limited
Canton, Ohio, United States, 44718
United States, Oklahoma
Lynn Institute of Norman
Norman, Oklahoma, United States, 73069
United States, South Carolina
C.S.R.A. Renal Services
Aiken, South Carolina, United States, 29801
Pharmacorp Clinical Trials
Charleston, South Carolina, United States, 29412
Mountain View Clinical Research
Greer, South Carolina, United States, 29651
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Texas
Research Across America
Houston, Texas, United States, 77054
Millenium Clinical Research
Houston, Texas, United States, 77054
Renal Associates
San Antonio, Texas, United States, 78215
Cetero
San Antonio, Texas, United States, 78229
Panacea Clinical Research
San Antonio, Texas, United States, 78228
United States, Washington
Multicare Research Institute (WA)
Tacoma, Washington, United States, 98405
Sponsors and Collaborators
Concert Pharmaceuticals
Investigators
Study Director: LuAnn Sabounjian Concert Pharmaceuticals
  More Information

No publications provided

Responsible Party: Concert Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01487109     History of Changes
Other Study ID Numbers: CP505.2001
Study First Received: December 5, 2011
Last Updated: July 8, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Concert Pharmaceuticals:
Type 2 diabetes
chronic kidney disease

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Kidney Diseases
Diabetes Mellitus
Renal Insufficiency, Chronic
Diabetic Nephropathies
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Renal Insufficiency
Diabetes Complications

ClinicalTrials.gov processed this record on September 22, 2014