Status:
COMPLETED
Safety & Tolerability Study of CTP-499 in Patients With Moderate Chronic Kidney Disease
Lead Sponsor:
Concert Pharmaceuticals
Conditions:
Stage 3 Chronic Kidney Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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.
Detailed Description
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-dia...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT01460199
Start Date
August 1 2011
End Date
December 1 2011
Last Update
May 24 2013
Active Locations (3)
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1
West Coast Clinical Trials
Costa Mesa, California, United States
2
Southern California Clinical Research
Garden Grove, California, United States
3
Orange County Research Center
Tustin, California, United States