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Clinical Trials/NCT00531440
NCT00531440CompletedPhase 3

A 2 Year Extension to a 1 Year Multicenter, Randomized, Open Label, Parallel Group Study of the Safety, Tolerability and Efficacy of Two Doses (1.5 and 3 mg/Day) of Everolimus (RAD001) With Basiliximab, Corticosteroids and Optimized Administration of Cyclosporine in de Novo Renal Transplant Recipients.

Novartis Pharmaceuticals1 site in 1 country256 target enrollmentStarted: November 2001Last updated:
Conditions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
256
Locations
1
Primary Endpoint
graft loss, death, biopsy-proven acute rejection,antibody-treated ,biopsy-proven chronic allograft nephropathy,retransplantation/dialysis up to 36m renal function measured by creatinine clearance Cockcroft-Gault)calculated glomerularfiltration rate

Study Overview

Brief Summary

This extension study is designed to provide long-term safety and efficacy data beyond 12 months up to Month 36.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients who are receiving study medication at Month 12 (CRAD001A2307) and sign a new Informed Consent to extend the treatment or observation period beyond Month
  • Female patients must agree to continue using an approved method of birth control throughout the study and for 3 months following the last dose of study medication.
  • Another Informed Consent was required for the extension amendment. This Informed Consent allowed for separate consent to the amendment study itself, and the retrospective collection of biopsies and/or the yearly protocol biopsies.
  • Inclusion and exclusion criteria were not changed, except that patients who completed the core study in follow-up became eligible to participate in the amended extension.

Exclusion Criteria

  • Patients who are receiving study medication and do not sign a new Informed Consent to extend the treatment and observation period beyond Month 12 cannot enter the extension.

Outcomes

Primary Outcomes

graft loss, death, biopsy-proven acute rejection,antibody-treated ,biopsy-proven chronic allograft nephropathy,retransplantation/dialysis up to 36m renal function measured by creatinine clearance Cockcroft-Gault)calculated glomerularfiltration rate

Secondary Outcomes

  • biopsy-proven acute rejection episodes,graft loss, deathor lost to follow-up 6,12,24&3677 Mths both groups.assess the incidence of graft loss, death, biopsy-proven acute rejection, antibody-treated acute rejection, clinically-confirmed acute rejection.

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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