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

Phase 1

Completed

• Conditions: Stage 3 Chronic Kidney Disease
• Interventions: Drug: placebo; Drug: CTP-499

• Registration Number: NCT01460199
• Lead Sponsor: Concert Pharmaceuticals

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-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

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-10-20
• Study First Submitted QC: 2011-10-25
• Study First Posted: 2011-10-26
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-23
• Last Update Posted: 2013-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	Matching Placebo
CTP-499	CTP-499	-

Primary Outcome Measures

Name	Time	Method
Safety measures	4 weeks	number of adverse events, vital signs, ECGs, clinical laboratory measures and physical exams

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic Profile	4 weeks	Time Frame: Predose, 0, 1, 2, 3, 4, 6, 8, 12, 18, 24 hours Cmax, Tmax, Area Under the Curve (AUC)

Trial Locations

Locations (3)

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