Everolimus in a Cyclosporine Microemulsion-free Regimen Compared to a Low-dose Cyclosporine Microemulsion Regimen, in de Novo Kidney Transplant Patients
Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Organ Transplantation, Renal Transplantation
Intervention: Everolimus (Certican) (Drug); Cyclosporine (Neoral) (Drug); Steroid (Drug); Basiliximab (Simulect) (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Novartis Official(s) and/or principal investigator(s): Novartis, Study Director, Affiliation: Novartis
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.
Clinical Details
Official title: A 12 Month, Multicenter, Randomized, Parallel, Open-label Study, to Evaluate Renal Function and Efficacy of Everolimus With Basiliximab and Cyclosporine Microemulsion Discontinuation at 3 Month Post-transplant Versus Minimization, in de Novo Kidney Transplant Recipients
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Renal Function Measured by Calculated Glomerular Filtration Rate (GFR Calculated According to the Nankivell Formula)
Secondary outcome: Number of Participants With Biopsy-proven Acute Rejection (BPAR) Episodes, Graft Loss, Death or Loss to Follow-upSerum Creatinine at Month 6 and 12 Calculated Creatinine Clearance at 6 Month and 12 Month Safety Based on Adverse Event (AE) Reporting
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 protocol amendments for each study, and the one clinical study report for
both.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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.
Locations and Contacts
Additional Information
Starting date: July 2005
Last updated: March 28, 2011
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