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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Concert Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01460199
First received: October 20, 2011
Last updated: May 23, 2013
Last verified: May 2013
  Purpose

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 Intervention Phase
Stage 3 Chronic Kidney Disease
Drug: CTP-499
Drug: placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Concert Pharmaceuticals:

Primary Outcome Measures:
  • Safety measures [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    number of adverse events, vital signs, ECGs, clinical laboratory measures and physical exams


Secondary Outcome Measures:
  • Pharmacokinetic Profile [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Time Frame: Predose, 0, 1, 2, 3, 4, 6, 8, 12, 18, 24 hours Cmax, Tmax, Area Under the Curve (AUC)


Enrollment: 33
Study Start Date: August 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)


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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Concert Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01460199     History of Changes
Other Study ID Numbers: CP505.1003
Study First Received: October 20, 2011
Last Updated: May 23, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 20, 2014