Safety & Tolerability Study of CTP-499 in Patients With Moderate Chronic Kidney Disease
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ClinicalTrials.gov Identifier: NCT01460199 |
Recruitment Status :
Completed
First Posted : October 26, 2011
Last Update Posted : May 24, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Stage 3 Chronic Kidney Disease | Drug: CTP-499 Drug: placebo | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 33 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Multi Center, Double-Blind, Two-Arm,Placebo Controlled, Randomized Safety and Tolerability Study of CTP-499 in Non-Dialysis Patients With Stage 3 Chronic Kidney Disease |
Study Start Date : | August 2011 |
Actual Primary Completion Date : | December 2011 |
Actual Study Completion Date : | December 2011 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo
Matching Placebo
|
Drug: placebo
tablets |
Experimental: CTP-499 |
Drug: CTP-499
3 X 200 mg tablets (QD for 2 weeks) 3 x 200 mg tablets (BID for 2 weeks) |
- Safety measures [ Time Frame: 4 weeks ]number of adverse events, vital signs, ECGs, clinical laboratory measures and physical exams
- Pharmacokinetic Profile [ Time Frame: 4 weeks ]Time Frame: Predose, 0, 1, 2, 3, 4, 6, 8, 12, 18, 24 hours Cmax, Tmax, Area Under the Curve (AUC)

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patient has a diagnosis of chronic kidney disease
- If taking antihypertensive and antidiabetes medications, regimen must be stable for a minimum of 4 weeks
- Patient has systolic blood pressure less than or equal to 160 mm Hg and diastolic blood pressure less than or equal to 95 mm Hg
Exclusion Criteria:
- Patient has concurrent condition such as uncontrolled inflammatory disease, acute infection or clinically unstable autoimmune, endocrine, neurological, psychiatric, retinal, cardiovascular, bronchopulmonary, hepatic, gastrointestinal or musculoskeletal disorder
- Patient has acute, active and/or current unstable renal impairment disease
- Patient has been hospitalized for acute renal failure in the past year
- Patient has active malignancy or a history of neoplastic disease
- Patient has QTc interval > 450 milliseconds
- Patient is currently on cytotoxic or other immunosuppressive therapy

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01460199
United States, California | |
West Coast Clinical Trials | |
Costa Mesa, California, United States | |
Southern California Clinical Research | |
Garden Grove, California, United States | |
Orange County Research Center | |
Tustin, California, United States |
Study Director: | James Shipley, MD | Concert Pharmaceuticals |
Responsible Party: | Concert Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT01460199 |
Other Study ID Numbers: |
CP505.1003 |
First Posted: | October 26, 2011 Key Record Dates |
Last Update Posted: | May 24, 2013 |
Last Verified: | May 2013 |
Kidney Diseases Renal Insufficiency, Chronic Urologic Diseases Renal Insufficiency |