NCT01460199

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

A Multi Center, Double-Blind, Two-Arm,Placebo Controlled, Randomized Safety and Tolerability Study of CTP-499 in Non-Dialysis Patients With Stage 3 Chronic Kidney Disease

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Concert Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Stage 3 Chronic Kidney Disease

Interventions

Type	Name	Description
DRUG	CTP-499	3 X 200 mg tablets (QD for 2 weeks) 3 x 200 mg tablets (BID for 2 weeks)
DRUG	placebo	tablets

Timeline

• Start date: 2011-08-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2011-10-26
• Last updated: 2013-05-24

Locations

3 sites across 1 country: United States