Everolimus in a Cyclosporine Microemulsion-free Regimen Compared to a Low-dose Cyclosporine Microemulsion Regimen, in de Novo Kidney Transplant Patients
NCT00154284 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 114
Last updated 2018-08-09
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 recipients.
Conditions
- Organ Transplantation, Renal Transplantation
Interventions
- DRUG
-
Everolimus (Certican)
- DRUG
-
Cyclosporine (Neoral)
- DRUG
-
Steroid
Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
- DRUG
-
Basiliximab (Simulect)
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Novartis · Novartis
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-07-31
- Primary Completion
- 2008-07-31
- Completion
- 2008-07-31
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