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

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Stage 3 Chronic Kidney Disease

Intervention / Treatment
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* Drug: CTP-499
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Matching Placebo | Drug: placebo<br>* tablets<br>|
| Experimental: CTP-499<br> | Drug: CTP-499<br>* 3 X 200 mg tablets (QD for 2 weeks) 3 x 200 mg tablets (BID for 2 weeks)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety measures | number of adverse events, vital signs, ECGs, clinical laboratory measures and physical exams | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |