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

Completed · Phase 1 · Has a placebo group

Conditions studied: Stage 3 Chronic Kidney Disease

In brief

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.

Key facts

Study ID

NCT01460199

Run by

Concert Pharmaceuticals

People needed

33

Starts

2011-08-01

Expected to finish

2011-12-01

Last updated by the study team

2013-05-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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