Status:
COMPLETED
ASCERTAIN: Assessment of Everolimus in Addition to Calcineurin Inhibitor Reduction in the Maintenance of Renal Transplant Recipients
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Renal Transplantation
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The study is designed to evaluate whether the initiation of everolimus together with the reduction or discontinuation of calcineurin inhibitors (CNIs) will improve graft function in the maintenance of...
Eligibility Criteria
Inclusion
- Male or female patient at least 18 years of age.
- Patient who has undergone a primary or secondary renal transplant 12-96 months ago from a living related or unrelated donor or a cadaveric donor.
- Patient receiving cyclosporine microemulsion with a C2-h level ≥ 400 ng/mL or tacrolimus with a C0-h level ≥ 4 ng/mL with or without mycophenolic acid or azathioprine plus or minus steroids.
- The immunosuppressive regimen must remain unchanged within the last 3 months.
- Patient with renal impairment defined as GFR between 30 and 70 mL/min/1.73 m\^2 by Cockcroft-Gault formula.
Exclusion
- Patient who is recipient of multiple organ transplants.
- Patient with protein/creatinine ratio ≥ 150 (mg/mmol).
- Patient with a treated acute rejection episode within the last 3 months.
- Patient with any past or present BK-polyomavirus nephropathy.
- Patient with de novo or recurrent glomerular nephritis.
- Other protocol defined inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
394 Patients enrolled
Trial Details
Trial ID
NCT00170846
Start Date
February 1 2005
End Date
October 1 2009
Last Update
January 27 2015
Active Locations (1)
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1
Novartis
Basel, Switzerland