ELiTE-Respect transplantation study announced

New liver transplantation study to evaluate the efficacy, safety, and tolerability of three different immunosuppressive strategies in liver transplant patients

27 February 2003, Brussels, Belgium – Senior trial investigators today announced the opening of a new liver transplant study to investigate the efficacy, safety, and tolerability of three different regimes of immunosuppressive therapy over a period of 12 months. The study aims to recruit 500 liver transplant patients in total, from approximately 40 centres worldwide.

The objective of the ELiTE-Respect study is to assess renal function (calculated creatinine clearance) in patients receiving tacrolimus in standard dosage, or tacrolimus in reduced dosage with the lower toxicity immunosupressant CellCept® (mycophenolate mofetil, MMF), or delayed reduced dose tacrolimus under the protection of CellCept® and Zenapax® (daclizumab). Corticosteroids will be used in all arms but the dose will be reduced to minimal levels or even withdrawn by 3 months, if immunologically appropriate. The results of this study will provide physicians with important information on the optimal immunosuppressive regimen for liver transplant patients.

Senior investigators of the ELiTE-Respect Study are Professor James Neuberger, Professor of Hepatology and Mr David Mayer, Consultant Liver Transplant Surgeon, both based at the Queen Elizabeth Hospital, Birmingham, UK. Mr Mayer comments, "The focus in transplantation is now shifting; increasingly we are looking to develop long-term, low-toxicity treatment strategies which will result in patients retaining their transplanted organs for longer whilst minimising the risk of kidney damage."

Professor Neuberger continued, "With the ELiTE-Respect Study, we have the opportunity to evaluate established immunosuppressant treatment regimens that have never before been compared in such a way. We hope to show that CellCept® in combination with corticosteroids, or CellCept® in combination with Zenapax® and corticosteroids, can allow for the safe reduction of tacrolimus to non-toxic levels with no loss in efficacy, and improved outcomes."

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Notes to Editors:

The ELiTE-Respect Study is an open label study with 3 parallel arms:
- Group A: tacrolimus + corticosteroids
- Group B: CellCept + low dose tacrolimus + corticosteroids
- Group C: daclizumab + CellCept + low dose tacrolimus (at day 5) + corticosteroids
The study will be open to either male or female first time orthotopic (whole or split) liver transplant recipients, aged 18 years or above.
40 centres will be participating in the ELiTE-Respect Study

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