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

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ClinicalTrials.gov Identifier: NCT01460199
Recruitment Status : Completed
First Posted : October 26, 2011
Last Update Posted : May 24, 2013
Sponsor:
Information provided by (Responsible Party):
Concert Pharmaceuticals

Study Description
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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.

Condition or disease Intervention/treatment Phase
Stage 3 Chronic Kidney Disease Drug: CTP-499 Drug: placebo Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 Start Date : August 2011
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arms and Interventions
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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)


Outcome Measures
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Primary Outcome Measures :
  1. Safety measures [ Time Frame: 4 weeks ]
    number of adverse events, vital signs, ECGs, clinical laboratory measures and physical exams


Secondary Outcome Measures :
  1. 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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01460199


Locations
United States, California
West Coast Clinical Trials
Costa Mesa, California, United States
Southern California Clinical Research
Garden Grove, California, United States
Orange County Research Center
Tustin, California, United States
Sponsors and Collaborators
Concert Pharmaceuticals
Investigators
Study Director: James Shipley, MD Concert Pharmaceuticals
More Information
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Responsible Party: Concert Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01460199     History of Changes
Other Study ID Numbers: CP505.1003
First Posted: October 26, 2011    Key Record Dates
Last Update Posted: May 24, 2013
Last Verified: May 2013

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency