Status:
COMPLETED
A Phase 2 Study to Evaluate the Safety and Efficacy of CTP-499 in Type 2 Diabetic Nephropathy Patients
Lead Sponsor:
Concert Pharmaceuticals
Conditions:
Type 2 Diabetes Mellitus
Chronic Kidney Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 rece...
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 w...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT01487109
Start Date
January 1 2012
End Date
January 1 2015
Last Update
August 16 2021
Active Locations (49)
Enter a location and click search to find clinical trials sorted by distance.
1
Agave Clinical Research
Tempe, Arizona, United States, 85282
2
Harrisburg Family Medical Center
Harrisburg, Arkansas, United States, 72432
3
Arkansas Primary Care Clinic
Little Rock, Arkansas, United States, 72204
4
Providence Clinical Research
Burbank, California, United States, 91505