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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | matching placebo tablets |
|
| CTP-499 | Active Comparator | 600 mg tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CTP-499 | Drug | 600 mg tablet twice daily |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the change in urinary albumin to creatinine ratio | Weeks 16, 20, 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| LuAnn Sabounjian | Concert Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Agave Clinical Research | Tempe | Arizona | 85282 | United States | ||
| Harrisburg Family Medical Center |
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| Drug |
Matching placebo tablet |
|
| 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 |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000626018 | 1-(5-hydroxyhexyl)-3,7-dimethylxanthine |
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