A Phase 2 Study to Evaluate the Safety and Efficacy of CTP-499 in Type 2 Diabetic Nephropathy Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Concert Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01487109
First received: December 5, 2011
Last updated: July 8, 2014
Last verified: July 2014
  Purpose

This study is being conducted to evaluate the safety and efficacy of treatment with CTP-499 for 24 weeks in patients with chronic kidney disease, Type 2 diabetic nephropathy and who are currently receiving treatment with an angiotensin converting enzyme inhibitor (ACEI) and/or angiotensin II receptor blocker (ARB).


Condition Intervention Phase
Type 2 Diabetes Mellitus
Chronic Kidney Disease
Drug: CTP-499
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of CTP-499 in Type 2 Diabetic Nephropathy Patients Currently Treated With ACEI and/or ARB Therapy

Resource links provided by NLM:


Further study details as provided by Concert Pharmaceuticals:

Primary Outcome Measures:
  • To assess the change in urinary albumin to creatinine ratio [ Time Frame: Weeks 16, 20, 24 ] [ Designated as safety issue: No ]

Estimated Enrollment: 170
Study Start Date: January 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
matching placebo tablets
Drug: Placebo
Matching placebo tablet
Active Comparator: CTP-499
600 mg tablet
Drug: CTP-499
600 mg tablet twice daily

Detailed Description:

There are two parts to this study, each part includes double-blind treatment with either CTP-499 or placebo. Part 1 will evaluate the safety and efficacy of treatment with CTP-499 twice daily for 24 weeks. Part 2 will evaluate the effects of longer term dosing for an additional 24 weeks. Following Part 2, patients will be allowed to participate in an Open Label extension with CTP-499 for a period of an additional 48 weeks.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female 18 years or older
  • Patient diagnosed with Type 2 diabetes mellitus and chronic kidney disease
  • On a stable regimen of ACE inhibitors and/or ARB drugs for a minimum of 4 weeks
  • Not expected to start dialysis for one year
  • Patient has blood pressure less than or equal to 145/90 mm Hg
  • Patient has UACR greater than or equal to 200 mg/g if male and 300 mg/g if female but not more than 5000 mg/g
  • Patient has glycosylated hemoglobin A1c less than or equal to 10.5%

Exclusion Criteria:

  • Patient has concurrent condition such as uncontrolled inflammatory disease, acute infection or other unstable illnesses
  • Patient has a history of allergy or sensitivity to pentoxifylline or methylxanthines
  • Patient has acute, active and/or unstable renal impairment or has been hospitalized for acute renal failure within the previous year
  • Patient has active malignancy or history of neoplastic disease
  • Patient has a QTc interval greater than 450 milliseconds
  • Patient has ALT or AST greater than 3 times the upper limit of normal or a potassium greater than or equal to 5.5mEq/L at screening
  • Patient is breast feeding or pregnant
  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: NCT01487109

  Show 49 Study Locations
Sponsors and Collaborators
Concert Pharmaceuticals
Investigators
Study Director: LuAnn Sabounjian Concert Pharmaceuticals
  More Information

No publications provided

Responsible Party: Concert Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01487109     History of Changes
Other Study ID Numbers: CP505.2001
Study First Received: December 5, 2011
Last Updated: July 8, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Concert Pharmaceuticals:
Type 2 diabetes
chronic kidney disease

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Kidney Diseases
Renal Insufficiency, Chronic
Diabetic Nephropathies
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Renal Insufficiency
Diabetes Complications

ClinicalTrials.gov processed this record on October 01, 2014