Back to resultsA Phase 2 Study to Evaluate the Safety and Efficacy of CTP-499 in Type 2 Diabetic Nephropathy Patients
Primary Purpose
Type 2 Diabetes Mellitus, Chronic Kidney Disease
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CTP-499
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Type 2 diabetes, chronic kidney disease
Eligibility 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
Sites / Locations
- Agave Clinical Research
- Harrisburg Family Medical Center
- Arkansas Primary Care Clinic
- Providence Clinical Research
- California Institute of Renal Research
- SC Clinical Research
- Premiere Clinical Research
- Long Beach Center for Clinical Research
- Premiere Clinical Research
- UCLA Kidney Transplant Research
- David Geffen School of Medicine Division of Nephrology
- Desert Oasis Healthcare Medical Group
- Apex Research of Riverside
- River City Clinical Research
- California Institute of Renal Research
- Samsun Clinic
- Orange County Research Center
- Infosphere Clinical Research
- Creekside Endocrine Associates
- Palm Spring Research Institute
- San Marcus Research Clinic, Inc.
- Advanced Pharma CR
- Ormond Medical Arts Pharmaceutical Research
- Clincal Research of Central Florida
- River Birch Research Alliance
- Apex Medical Research
- University of Chicago Medical Center
- American Health Network of IN
- American Healthcare Network of Indiana
- Medstar Health Research Institute
- Brigham and Women's Hospital
- Harvard Medical School Beth Israel Deaconess Medical Center
- Apex Medical Research MI
- Clinical Research Consultants (MO)
- The Rogosin Institute
- Clinical Research Development Associates (NY)
- University of North Carolina School of Medicine
- Clinical Research Limited
- Lynn Institute of Norman
- C.S.R.A. Renal Services
- Pharmacorp Clinical Trials
- Mountain View Clinical Research
- Vanderbilt University Medical Center
- Millenium Clinical Research
- Research Across America
- Renal Associates
- Panacea Clinical Research
- Cetero
- Multicare Research Institute (WA)
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Placebo
CTP-499
Arm Description
matching placebo tablets
600 mg tablet
Outcomes
Primary Outcome Measures
To assess the change in urinary albumin to creatinine ratio
Secondary Outcome Measures
Full Information
NCT ID
NCT01487109
First Posted
December 5, 2011
Last Updated
August 6, 2021
Sponsor
Concert Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT01487109
Brief Title
A Phase 2 Study to Evaluate the Safety and Efficacy of CTP-499 in Type 2 Diabetic Nephropathy Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Concert Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Chronic Kidney Disease
Keywords
Type 2 diabetes, chronic kidney disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
170 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
matching placebo tablets
Arm Title
CTP-499
Arm Type
Active Comparator
Arm Description
600 mg tablet
Intervention Type
Drug
Intervention Name(s)
CTP-499
Intervention Description
600 mg tablet twice daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo tablet
Primary Outcome Measure Information:
Title
To assess the change in urinary albumin to creatinine ratio
Time Frame
Weeks 16, 20, 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
LuAnn Sabounjian
Organizational Affiliation
Concert Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Agave Clinical Research
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85282
Country
United States
Facility Name
Harrisburg Family Medical Center
City
Harrisburg
State/Province
Arkansas
ZIP/Postal Code
72432
Country
United States
Facility Name
Arkansas Primary Care Clinic
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72204
Country
United States
Facility Name
Providence Clinical Research
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
California Institute of Renal Research
City
Chula Vista
State/Province
California
ZIP/Postal Code
91910
Country
United States
Facility Name
SC Clinical Research
City
Garden Grove
State/Province
California
ZIP/Postal Code
92844
Country
United States
Facility Name
Premiere Clinical Research
City
Lakewood
State/Province
California
ZIP/Postal Code
90712
Country
United States
Facility Name
Long Beach Center for Clinical Research
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Premiere Clinical Research
City
Long Beach
State/Province
California
ZIP/Postal Code
90807
Country
United States
Facility Name
UCLA Kidney Transplant Research
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
David Geffen School of Medicine Division of Nephrology
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Desert Oasis Healthcare Medical Group
City
Palm Springs
State/Province
California
ZIP/Postal Code
92262
Country
United States
Facility Name
Apex Research of Riverside
City
Riverside
State/Province
California
ZIP/Postal Code
92505
Country
United States
Facility Name
River City Clinical Research
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
California Institute of Renal Research
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Samsun Clinic
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93110
Country
United States
Facility Name
Orange County Research Center
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Facility Name
Infosphere Clinical Research
City
West Hills
State/Province
California
ZIP/Postal Code
91307
Country
United States
Facility Name
Creekside Endocrine Associates
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209
Country
United States
Facility Name
Palm Spring Research Institute
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
San Marcus Research Clinic, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33015
Country
United States
Facility Name
Advanced Pharma CR
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Ormond Medical Arts Pharmaceutical Research
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Clincal Research of Central Florida
City
Winter Haven
State/Province
Florida
ZIP/Postal Code
33880
Country
United States
Facility Name
River Birch Research Alliance
City
Blue Ridge
State/Province
Georgia
ZIP/Postal Code
30513
Country
United States
Facility Name
Apex Medical Research
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60616
Country
United States
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
American Health Network of IN
City
Avon
State/Province
Indiana
ZIP/Postal Code
46123
Country
United States
Facility Name
American Healthcare Network of Indiana
City
Greenfield
State/Province
Indiana
ZIP/Postal Code
46140
Country
United States
Facility Name
Medstar Health Research Institute
City
Hyattsville
State/Province
Maryland
ZIP/Postal Code
20782
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Harvard Medical School Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Apex Medical Research MI
City
Flint
State/Province
Michigan
ZIP/Postal Code
48504
Country
United States
Facility Name
Clinical Research Consultants (MO)
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
The Rogosin Institute
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Clinical Research Development Associates (NY)
City
Rosedale
State/Province
New York
ZIP/Postal Code
11422
Country
United States
Facility Name
University of North Carolina School of Medicine
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Clinical Research Limited
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Lynn Institute of Norman
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73069
Country
United States
Facility Name
C.S.R.A. Renal Services
City
Aiken
State/Province
South Carolina
ZIP/Postal Code
29801
Country
United States
Facility Name
Pharmacorp Clinical Trials
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29412
Country
United States
Facility Name
Mountain View Clinical Research
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Millenium Clinical Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
Research Across America
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
Renal Associates
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Panacea Clinical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78228
Country
United States
Facility Name
Cetero
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Multicare Research Institute (WA)
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Phase 2 Study to Evaluate the Safety and Efficacy of CTP-499 in Type 2 Diabetic Nephropathy Patients
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