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

• ClinicalTrials.gov Identifier: NCT01460199
• Recruitment Status: Completed
• First Posted: October 26, 2011
• Last Update Posted: May 24, 2013
• Sponsor: Concert Pharmaceuticals
• Information provided by (Responsible Party): Concert Pharmaceuticals

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Stage 3 Chronic Kidney Disease	Drug: CTP-499; Drug: placebo	Phase 1

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 33 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: August 2011
• Actual Primary Completion Date: December 2011
• Actual Study Completion Date: December 2011

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Placebo; Matching Placebo	Drug: placebo; tablets
Experimental: CTP-499	Drug: CTP-499; 3 X 200 mg tablets (QD for 2 weeks) 3 x 200 mg tablets (BID for 2 weeks)

Outcome Measures

Primary Outcome Measures :

1. Safety measures [ Time Frame: 4 weeks ]
   number of adverse events, vital signs, ECGs, clinical laboratory measures and physical exams

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, California

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

Sponsors and Collaborators

Concert Pharmaceuticals

Investigators

• Study Director: James Shipley, MD; Concert Pharmaceuticals

More Information

• Responsible Party: Concert Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT01460199
• Other Study ID Numbers: CP505.1003
• First Posted: October 26, 2011
• Last Update Posted: May 24, 2013
• Last Verified: May 2013

Additional relevant MeSH terms:

Kidney Diseases; Renal Insufficiency, Chronic; Urologic Diseases; Renal Insufficiency