Status:
COMPLETED
Everolimus in a Cyclosporine Microemulsion-free Regimen Compared to a Low-dose Cyclosporine Microemulsion Regimen, in de Novo Kidney Transplant Patients
Lead Sponsor:
Novartis
Conditions:
Organ Transplantation, Renal Transplantation
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of everolimus in combination with basiliximab, and steroids with and without cyclosporine microemulsion in de novo kidney transplant re...
Detailed Description
This is a combined analysis using 81 patients randomized and treated in CRAD001A2419 (NCT00154284) with 33 randomized and treated in CRAD001A2423 (NCT00170807). This approach is reflected in the proto...
Eligibility Criteria
Inclusion
- Recipients of a first renal transplant from a primary cadaveric or non-HLA identical living related donor.
- Renal cold ischemic time \< 36 hours.
- Age of donor \< 65 years.
Exclusion
- Patients who have received an investigational drug within 4 weeks of baseline period.
- Patients who are recipients of multiple organ transplants, including any organ other than kidney.
- Recipients of non-heart beating donor organs.
- Other protocol-defined exclusion criteria may apply.
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT00154284
Start Date
July 1 2005
End Date
July 1 2008
Last Update
August 9 2018
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