Trial information
(Elite ReSpECT Study) - A Study of Zenapax (Daclizumab) in Patients Who Have Undergone Liver Transplantation
Status: Completed
Protocol number: ML17521
Sponsor: F Hoffman-La Roche Ltd; Queen Elizabeth Hospital Birmingham NHS Trust
Company division: Pharmaceutical
Official Scientific Title: An exploratory study to evaluate the efficacy, safety, particularly renal function, and tolerability of three regimes of immunosuppressive therapy, in patients who have undergone liver transplantation.
Brief summary: This study will evaluate renal function, efficacy and safety in liver transplant patients receiving immunosuppressive therapy including Cellcept, or CellCept + Zenapax, against a comparator regimen. The anticipated time on study treatment is 6-12 months, and the target sample size is 500+ individuals.
Target sample size is 525.
Study phase: III
Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
Condition: Liver Transplantation
Intervention type: Drug
Intervention name: daclizumab[Zenapax]
Primary outcome: 1. Renal function, as measured by change from baseline in calculated creatinine clearance
Key secondary outcomes: 1. Change from baseline for serum creatinine at 13, 26, 52 wks and for calculated creatinine clearance at 13, 26 wks posttransplantation
Safety: AEs, hypertension, diabetes, hyperlipidaemia, and OIs
Inclusion criteria:
- male or female patients >=16 years of age;
- single-organ liver transplant (whole or split);
- women of child-bearing potential must be prepared to use reliable contraception throughout the study, and for up to 4 months after the last dose of study medication.
Exclusion criteria:
- previous organ transplant;
- pregnant women;
- HIV positive patients;
- prohibited immunosuppressive agents prior to transplant (or known to be required after transplant);
- patients who have received another investigational drug within 30 days preceding transplantation.
Gender: Males or Females
Age limits: Min: 16 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 05/23/2005
Date last updated: 9/29/2008
Link to trial result
This trial was conducted at the following locations:
Belgium
Finland
France
- Clichy
- Lille
- Lyon
- Toulouse
- Villejuif
Germany
- Berlin
- Essen
- Frankfurt Am Main
- Heidelberg
- Kiel
- Leipzig
- Regensburg
Norway
Spain
- Barcelona
- Hospitalet de Llobregat
- La Coruna
- Madrid
- Santiago de Compostela
- Sevilla
Sweden
Switzerland
United Kingdom
