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

Stage 3 Chronic Kidney Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01460199
• Other study ID #: CP505.1003
• Status: Completed
• Phase: Phase 1
• First received: October 20, 2011
• Last updated: May 23, 2013
• Start date: August 2011
• Est. completion date: December 2011

Study information

• Verified date: May 2013
• Source: Concert Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Diseases
• Renal Insufficiency, Chronic
• Stage 3 Chronic Kidney Disease

Intervention

Drug:
• CTP-499
3 X 200 mg tablets (QD for 2 weeks) 3 x 200 mg tablets (BID for 2 weeks)
• placebo
tablets

Locations

Country	Name	City	State
United States	West Coast Clinical Trials	Costa Mesa	California
United States	Southern California Clinical Research	Garden Grove	California
United States	Orange County Research Center	Tustin	California

Sponsors (1)

Lead Sponsor	Collaborator
Concert Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety measures	number of adverse events, vital signs, ECGs, clinical laboratory measures and physical exams	4 weeks	Yes
Secondary	Pharmacokinetic Profile	Time Frame: Predose, 0, 1, 2, 3, 4, 6, 8, 12, 18, 24 hours Cmax, Tmax, Area Under the Curve (AUC)	4 weeks	No