Clinical trial NCT01487109: A Phase 2 Study to Evaluate the Safety and Efficacy of CTP-499 in Type 2 Diabetic Nephropathy Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus
Chronic Kidney Disease
Keywords: Type 2 diabetes
chronic kidney disease
Lead sponsor: Concert Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2011-12-07
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

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 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

Primary outcomes:
measure: To assess the change in urinary albumin to creatinine ratio
timeFrame: Weeks 16, 20, 24
Secondary outcomes:
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Agave Clinical Research
state: Arizona
city: Harrisburg
country: United States
facility: Harrisburg Family Medical Center
state: Arkansas
city: Little Rock
country: United States
facility: Arkansas Primary Care Clinic
state: Arkansas
city: Burbank
country: United States
facility: Providence Clinical Research
state: California
city: Chula Vista
country: United States
facility: California Institute of Renal Research
state: California
city: Garden Grove
country: United States
facility: SC Clinical Research
state: California
city: Lakewood
country: United States
facility: Premiere Clinical Research
state: California
city: Long Beach
country: United States
facility: Long Beach Center for Clinical Research
state: California
city: Long Beach
country: United States
facility: Premiere Clinical Research
state: California
city: Los Angeles
country: United States
facility: UCLA Kidney Transplant Research
state: California
city: Los Angeles
country: United States
facility: David Geffen School of Medicine Division of Nephrology
state: California
city: Palm Springs
country: United States
facility: Desert Oasis Healthcare Medical Group
state: California
city: Riverside
country: United States
facility: Apex Research of Riverside
state: California
city: Sacramento
country: United States
facility: River City Clinical Research
state: California
city: San Diego
country: United States
facility: California Institute of Renal Research
state: California
city: Santa Barbara
country: United States
facility: Samsun Clinic
state: California
city: Tustin
country: United States
facility: Orange County Research Center
state: California
city: West Hills
country: United States
facility: Infosphere Clinical Research
state: California
city: Denver
country: United States
facility: Creekside Endocrine Associates
state: Colorado
city: Hialeah
country: United States
facility: Palm Spring Research Institute
state: Florida
city: Miami
country: United States
facility: San Marcus Research Clinic, Inc.
state: Florida
city: Miami
country: United States
facility: Advanced Pharma CR
state: Florida
city: Ormond Beach
country: United States
facility: Ormond Medical Arts Pharmaceutical Research
state: Florida
city: Winter Haven
country: United States
facility: Clincal Research of Central Florida
state: Florida
city: Blue Ridge
country: United States
facility: River Birch Research Alliance
state: Georgia
city: Chicago
country: United States
facility: Apex Medical Research
state: Illinois
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Avon
country: United States
facility: American Health Network of IN
state: Indiana
city: Greenfield
country: United States
facility: American Healthcare Network of Indiana
state: Indiana
city: Hyattsville
country: United States
facility: Medstar Health Research Institute
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Harvard Medical School Beth Israel Deaconess Medical Center
state: Massachusetts
city: Flint
country: United States
facility: Apex Medical Research MI
state: Michigan
city: Kansas City
country: United States
facility: Clinical Research Consultants (MO)
state: Missouri
city: New York
country: United States
facility: The Rogosin Institute
state: New York
city: Rosedale
country: United States
facility: Clinical Research Development Associates (NY)
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina School of Medicine
state: North Carolina
city: Canton
country: United States
facility: Clinical Research Limited
state: Ohio
city: Norman
country: United States
facility: Lynn Institute of Norman
state: Oklahoma
city: Aiken
country: United States
facility: C.S.R.A. Renal Services
state: South Carolina
city: Charleston
country: United States
facility: Pharmacorp Clinical Trials
state: South Carolina
city: Greer
country: United States
facility: Mountain View Clinical Research
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Houston
country: United States
facility: Millenium Clinical Research
state: Texas
city: Houston
country: United States
facility: Research Across America
state: Texas
city: San Antonio
country: United States
facility: Renal Associates
state: Texas
city: San Antonio
country: United States
facility: Panacea Clinical Research
state: Texas
city: San Antonio
country: United States
facility: Cetero
state: Texas
city: Tacoma
country: United States
facility: Multicare Research Institute (WA)
state: Washington
Study officials:
affiliation: Concert Pharmaceuticals
name: LuAnn Sabounjian
role: STUDY_DIRECTOR
References: