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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2011-12-31

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.

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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

Conditions

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Stage 3 Chronic Kidney Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo

Matching Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

tablets

CTP-499

Group Type EXPERIMENTAL

CTP-499

Intervention Type DRUG

3 X 200 mg tablets (QD for 2 weeks)

3 x 200 mg tablets (BID for 2 weeks)

Interventions

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CTP-499

3 X 200 mg tablets (QD for 2 weeks)

3 x 200 mg tablets (BID for 2 weeks)

Intervention Type DRUG

placebo

tablets

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No