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

May 23, 2013 updated by: Concert Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

33

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Costa Mesa, California, United States
        • West Coast Clinical Trials
      • Garden Grove, California, United States
        • Southern California Clinical Research
      • Tustin, California, United States
        • Orange County Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety measures
Time Frame: 4 weeks
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: 4 weeks
Time Frame: Predose, 0, 1, 2, 3, 4, 6, 8, 12, 18, 24 hours Cmax, Tmax, Area Under the Curve (AUC)
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Concert Pharmaceuticals

Investigators

  • Study Director: James Shipley, MD, Concert Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (ACTUAL)

December 1, 2011

Study Completion (ACTUAL)

December 1, 2011

Study Registration Dates

First Submitted

October 20, 2011

First Submitted That Met QC Criteria

October 25, 2011

First Posted (ESTIMATE)

October 26, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

May 24, 2013

Last Update Submitted That Met QC Criteria

May 23, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP505.1003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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