Trial information
A Study of a Steroid Sparing Regimen in Combination With CellCept, Zenapax and Sirolimus in the Prevention of Acute Renal Allograft Rejection.
Status: Terminated
Protocol number: ML18690
Sponsor: Roche Farma S.A.
Company division: Pharmaceutical
Official Scientific Title: An open-label study comparing a steroid sparing versus a standard steroid regimen in combination with CellCept, Zenapax and sirolimus in the prevention of acute renal allograft rejection
Brief summary: This study will compare the efficacy of a steroid free regimen against normal doses of corticosteroids for the prevention of an acute rejection, when given in conjunction with CellCept, Zenapax and sirolimus as maintenance therapy in the management of kidney transplant recipients. All patients will receive Zenapax (2mg/kg iv) within 24 hours before transplantation and 1mg/kg at week 2, CellCept 2g/day and standard doses of sirolimus and prednisolone. After 3 months, eligible patients will be randomized to a group continuing the same steroid regimen, or a group having steroids withdrawn over the subsequent 4 weeks. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals. Target sample size is
144.
Study phase: IV
Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
Condition: Kidney Transplantation
Intervention type: Drug
Intervention name: mycophenolate mofetil [CellCept]
Primary outcome: 1. Proportion of patients with an acute rejection episode 6 months post-randomization.
Key secondary outcomes: 1. Efficacy: Patient & graft survival, and rejection episodes, between baseline, randomization and Week 36 and 52; severity of rejection; time to first rejection; renal function. Safety: onset or severity of hypertension; adverse events; lab tests.
Inclusion criteria:
- male or female patients, >=18 years of age;
- single organ recipients of primary kidney allografts;
For withdrawal phase:
- absence of acute rejection within first 3 months;
- stable renal function;
- trough levels of CellCept and sirolimus within target range.
Exclusion criteria:
- patients previously treated with CellCept, Zenapax or sirolimus;
- history of malignancy within the last 5 years, except localised and treated non-melanoma skin cancer.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 06/16/2006
Date last updated: 12/2/2008
Link to trial result
This trial was conducted at the following locations:
Spain
- Barcelona
- Cadiz
- Granada
- Valencia
