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

Sponsor
Concert Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT01487109
Collaborator
(none)
170
Enrollment
49
Locations
2
Arms
36
Duration (Months)
3.5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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).

Condition or Disease Intervention/Treatment Phase
Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
170 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, 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
Study Start Date :
Jan 1, 2012
Actual Primary Completion Date :
Jan 1, 2015
Actual Study Completion Date :
Jan 1, 2015

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. To assess the change in urinary albumin to creatinine ratio [Weeks 16, 20, 24]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Agave Clinical Research Tempe Arizona United States 85282
2 Harrisburg Family Medical Center Harrisburg Arkansas United States 72432
3 Arkansas Primary Care Clinic Little Rock Arkansas United States 72204
4 Providence Clinical Research Burbank California United States 91505
5 California Institute of Renal Research Chula Vista California United States 91910
6 SC Clinical Research Garden Grove California United States 92844
7 Premiere Clinical Research Lakewood California United States 90712
8 Long Beach Center for Clinical Research Long Beach California United States 90806
9 Premiere Clinical Research Long Beach California United States 90807
10 UCLA Kidney Transplant Research Los Angeles California United States 90024
11 David Geffen School of Medicine Division of Nephrology Los Angeles California United States 90095
12 Desert Oasis Healthcare Medical Group Palm Springs California United States 92262
13 Apex Research of Riverside Riverside California United States 92505
14 River City Clinical Research Sacramento California United States 95816
15 California Institute of Renal Research San Diego California United States 92123
16 Samsun Clinic Santa Barbara California United States 93110
17 Orange County Research Center Tustin California United States 92780
18 Infosphere Clinical Research West Hills California United States 91307
19 Creekside Endocrine Associates Denver Colorado United States 80209
20 Palm Spring Research Institute Hialeah Florida United States 33012
21 San Marcus Research Clinic, Inc. Miami Florida United States 33015
22 Advanced Pharma CR Miami Florida United States 33136
23 Ormond Medical Arts Pharmaceutical Research Ormond Beach Florida United States 32174
24 Clincal Research of Central Florida Winter Haven Florida United States 33880
25 River Birch Research Alliance Blue Ridge Georgia United States 30513
26 Apex Medical Research Chicago Illinois United States 60616
27 University of Chicago Medical Center Chicago Illinois United States 60637
28 American Health Network of IN Avon Indiana United States 46123
29 American Healthcare Network of Indiana Greenfield Indiana United States 46140
30 Medstar Health Research Institute Hyattsville Maryland United States 20782
31 Brigham and Women's Hospital Boston Massachusetts United States 02115
32 Harvard Medical School Beth Israel Deaconess Medical Center Boston Massachusetts United States 02215
33 Apex Medical Research MI Flint Michigan United States 48504
34 Clinical Research Consultants (MO) Kansas City Missouri United States 64111
35 The Rogosin Institute New York New York United States 10021
36 Clinical Research Development Associates (NY) Rosedale New York United States 11422
37 University of North Carolina School of Medicine Chapel Hill North Carolina United States 27599
38 Clinical Research Limited Canton Ohio United States 44718
39 Lynn Institute of Norman Norman Oklahoma United States 73069
40 C.S.R.A. Renal Services Aiken South Carolina United States 29801
41 Pharmacorp Clinical Trials Charleston South Carolina United States 29412
42 Mountain View Clinical Research Greer South Carolina United States 29651
43 Vanderbilt University Medical Center Nashville Tennessee United States 37232
44 Millenium Clinical Research Houston Texas United States 77054
45 Research Across America Houston Texas United States 77054
46 Renal Associates San Antonio Texas United States 78215
47 Panacea Clinical Research San Antonio Texas United States 78228
48 Cetero San Antonio Texas United States 78229
49 Multicare Research Institute (WA) Tacoma Washington United States 98405

Sponsors and Collaborators

  • Concert Pharmaceuticals

Investigators

  • Study Director: LuAnn Sabounjian, Concert Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Concert Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01487109
Other Study ID Numbers:
  • CP505.2001
First Posted:
Dec 7, 2011
Last Update Posted:
Aug 16, 2021
Last Verified:
Jul 1, 2014
Keywords provided by Concert Pharmaceuticals
Type 2 diabetes
chronic kidney disease
Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Diabetic Nephropathies
Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Aug 16, 2021