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: May 16, 2013
Last verified: May 2013

December 5, 2011
May 16, 2013
January 2012
July 2013   (final data collection date for primary outcome measure)
To assess the change in urinary albumin to creatinine ratio [ Time Frame: Weeks 16, 20, 24 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01487109 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Phase 2 Study to Evaluate the Safety and Efficacy of CTP-499 in Type 2 Diabetic Nephropathy Patients
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

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).

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Type 2 Diabetes Mellitus
  • Chronic Kidney Disease
  • Drug: CTP-499
    600 mg tablet twice daily
  • Drug: Placebo
    Matching placebo tablet
  • Placebo Comparator: Placebo
    matching placebo tablets
    Intervention: Drug: Placebo
  • Active Comparator: CTP-499
    600 mg tablet
    Intervention: Drug: CTP-499
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
170
December 2013
July 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01487109
CP505.2001
No
Concert Pharmaceuticals
Concert Pharmaceuticals
Not Provided
Study Director: LuAnn Sabounjian Concert Pharmaceuticals
Concert Pharmaceuticals
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP