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

Concert Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Stage 3 Chronic Kidney Disease

Treatments

Drug: placebo

Drug: CTP-499

Study type

Interventional

Funder types

Industry

Identifiers

NCT01460199

CP505.1003

Details and patient eligibility

About

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.

Full 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-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

Enrollment

33 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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