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...
Date First Received: September 8, 2005
Last Updated: July 29, 2008
Verified by: Novartis, July 2008
Clinical Trial Phase: Phase 4 | Start Date:
Overall Status: Active, not recruiting
Brief Summary
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”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: Everolimus (RAD001)
Outcome Measures for this Clinical Trial
Primary Measures
- Renal function measured by calculated glomerular filtration rate (GFR), serum creatinine and calculated creatinine clearance
Secondary Measures
- Incidence of biopsy-proven acute rejection (BPAR) episodes, graft loss, death or loss to follow-up after 12 months
- Incidence of graft loss, death, BPAR episodes, antibody treated acute rejection episodes, clinically confirmed acute rejection episodes, clinically confirmed chronic rejection episodes and biopsy-proven chronic allograft nephropathy after 12 months
- Safety based on adverse event (AE) reporting
Criteria for Participation in this Clinical Trial
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.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 65 Years
Clinical Trial Sponsor Information
Lead Sponsor: Novartis
Overall Clinical Trial Officials and Contacts
Novartis Study Director Novartis
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00154284
Study ID Number: CRAD001A2419
ClinicalTrials.gov Identifier: NCT00154284
Health Authority: Spain: Spanish Agency of Medicines
Clinical Trials Authorship and Review
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