Back to resultsSafety & Tolerability Study of CTP-499 in Patients With Moderate Chronic Kidney Disease
Primary Purpose
Stage 3 Chronic Kidney Disease
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CTP-499
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Stage 3 Chronic Kidney Disease
Eligibility 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
Sites / Locations
- West Coast Clinical Trials
- Southern California Clinical Research
- Orange County Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
CTP-499
Arm Description
Matching Placebo
Outcomes
Primary Outcome Measures
Safety measures
number of adverse events, vital signs, ECGs, clinical laboratory measures and physical exams
Secondary Outcome Measures
Pharmacokinetic Profile
Time Frame: Predose, 0, 1, 2, 3, 4, 6, 8, 12, 18, 24 hours Cmax, Tmax, Area Under the Curve (AUC)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01460199
Brief Title
Safety & Tolerability Study of CTP-499 in Patients With Moderate Chronic Kidney Disease
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 Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Concert Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage 3 Chronic Kidney Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching Placebo
Arm Title
CTP-499
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
CTP-499
Intervention Description
3 X 200 mg tablets (QD for 2 weeks)
3 x 200 mg tablets (BID for 2 weeks)
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
tablets
Primary Outcome Measure Information:
Title
Safety measures
Description
number of adverse events, vital signs, ECGs, clinical laboratory measures and physical exams
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Pharmacokinetic Profile
Description
Time Frame: Predose, 0, 1, 2, 3, 4, 6, 8, 12, 18, 24 hours Cmax, Tmax, Area Under the Curve (AUC)
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Shipley, MD
Organizational Affiliation
Concert Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
West Coast Clinical Trials
City
Costa Mesa
State/Province
California
Country
United States
Facility Name
Southern California Clinical Research
City
Garden Grove
State/Province
California
Country
United States
Facility Name
Orange County Research Center
City
Tustin
State/Province
California
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety & Tolerability Study of CTP-499 in Patients With Moderate Chronic Kidney Disease
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