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This study is being conducted to evaluate the safety and tolerability of treatment with CTP-499 in non-dialysis patients associated with moderate chronic kidney disease.
This study will evaluate the safety and tolerability of treatment with CTP-499 starting with 600 milligrams (mg) once a day (QD) for 2 weeks followed by 600 mg twice a day (BID) for 2 weeks in non-dialysis patients associated with moderate chronic kidney disease defined as an estimated Glomerular Filtration Rate or eGFR that is 30-59 mL/min/1.73m2
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Matching Placebo |
|
| CTP-499 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CTP-499 | Drug | 3 X 200 mg tablets (QD for 2 weeks) 3 x 200 mg tablets (BID for 2 weeks) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety measures | number of adverse events, vital signs, ECGs, clinical laboratory measures and physical exams | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic Profile | Time Frame: Predose, 0, 1, 2, 3, 4, 6, 8, 12, 18, 24 hours Cmax, Tmax, Area Under the Curve (AUC) | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James Shipley, MD | Concert Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Coast Clinical Trials | Costa Mesa | California | United States | |||
| Southern California Clinical Research |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| C000626018 | 1-(5-hydroxyhexyl)-3,7-dimethylxanthine |
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| placebo |
| Drug |
tablets |
|
| Garden Grove |
| California |
| United States |
| Orange County Research Center | Tustin | California | United States |
| 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 |