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Everolimus vs MMF in De Novo Renal Transplant Recipients

NCT00658320Phase 3

Key facts

Status: Completed
Start: Feb 2008
Primary completion: Aug 2010
Countries: 1
Sponsor: Novartis
Modality: Small Molecules

Drugs: everolimus
Conditions: kidney transplant rejection

Overview

Phase 3, randomised, open-label trial of everolimus in kidney transplant rejection (2 arms), sponsored by Novartis. Primary endpoints: Composite Efficacy Endpoint (Biopsy Proven Acute Rejection, Graft Loss, Death, or Loss to Follow-up) at 12 months and Renal Function Measured by Calculated Glomerular Filtration Rate (cGFR) Using the Modification of Diet in Renal Disease (MDRD) Formula at 48 months. Started Feb 2008; status: completed.

Design

2 arms

Study design: RandomizedOpen-label

Everolimus + Reduced CsA
Everolimus (1.5 mg/day target 3-8 ng/mL) + Reduced dose Cyclosporine + Basiliximab + Corticosteroids
MMF + Standard CsA
MMF (2 g/day) + Standard dose Cyclosporine + Basiliximab + Corticosteroids

Who it enrols

Adult de novo renal transplant recipients (18-65 years) receiving a primary cadaveric or non-HLA identical living donor kidney. Excludes patients with prior transplants, multi-organ transplants, ABO incompatibility, positive cross-match, or significant hematological/hepatic abnormalities.

Endpoints

Primary

Composite Efficacy Endpoint (Biopsy Proven Acute Rejection, Graft Loss, Death, or Loss to Follow-up)12 months
Renal Function Measured by Calculated Glomerular Filtration Rate (cGFR) Using the Modification of Diet in Renal Disease (MDRD) Formula48 months

Secondary

Number Participants With Combined Graft Loss, Death or Loss to Follow-up12 months
Renal Function Measured by Calculated Glomerular Filtration Rate (cGFR) Using Modification of Diet in Renal Disease (MDRD) Formula12 months
Number of Participants With Combined Efficacy Endpoint: Graft Loss, Death, Loss to Follow-up and/or Treated Biopsy Proven Acute Rejection (BPAR)24 months
Renal Function Measured by Calculated Glomerular Filtration Rate (GFR) Using the Nankivell Formula48 months
Number of Participants With Adverse Events and Serious Adverse Events24 months
Everolimus Trough Levels48 months
Cyclosporine Trough Levels48 months

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