Safety & Tolerability Study of CTP-499 in Patients With Moderate Chronic Kidney Disease

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Concert Pharmaceuticals

Criteria

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