Status:
TERMINATED
Rapamycin as Treatment for Autosomal Dominant Polycystic Kidney Disease (ADPKD): The Role of Biomarkers in Predicting a Response to Therapy
Lead Sponsor:
Yale University
Conditions:
Autosomal Dominant Polycystic Kidney Disease
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
PHASE3
Brief Summary
Currently the only approved use for rapamycin (sirolimus) is for immunosuppression after renal transplantation. This trial is designed to determine whether rapamycin is safe and effective treatment f...
Detailed Description
This is a 2 year, open label trial to evaluate the role of rapamycin as treatment for ADPKD. Patients will be randomized 2:1 to the rapamycin arm or to standard therapy. The dose of rapamycin will be ...
Eligibility Criteria
Inclusion
- adult ADPKD patients aged 18-70
- combined kidney volume \>1200 ml
- estimated creatinine clearance \>60 ml/min
- absence of implanted ferromagnetic objects
Exclusion
- Age \>70
- uncontrolled hyperlipidemia
- Proteinuria \>500 mg/day
- unstable cerebral aneurysm
- active coronary artery disease
- diagnosis of another systemic condition affecting kidney function (ie: diabetes, hepatitis B or C, HIV)
- diagnosis of cancer other than skin cancer
- pregnancy or lactation
- presence of implanted ferromagnetic objects
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00920309
Start Date
June 1 2009
End Date
July 1 2010
Last Update
April 14 2014
Active Locations (1)
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1
Yale Center for Clinical Investigation
New Haven, Connecticut, United States, 06520