Study of Enteric-coated Mycophenolate Sodium (EC-MPS) With Steroid Withdrawal vs EC-MPS With Standard Steroid Regimen in de Novo Renal Transplant Recipients.

Novartis

Status and phase

Completed

Phase 3

Conditions

Kidney de Novo Transplant

Treatments

Drug: Enteric-coated Mycophenolate sodium (EC-MPS)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00238992

CERL080A2405ES01

Details and patient eligibility

About

All patients of the core study who are interested of being treated with EC-MPS will be included in an open-label extension study to collect further information on the long-term safety, tolerability and efficacy of this drug.

The purpose of this study is to evaluate the feasibility of steroid withdrawal in the setting of immunosuppression with a combination of EC-MPS, cyclosporine and steroids in de novo kidney allograft recipients.

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

Male or female patients undergoing first kidney transplant.
Patients aged 18 -70 years.
Patients receiving an ABO identical or compatible graft. Exclusion Criteria
Multi-organ recipients (e.g. kidney and pancreas) or previous transplant with any organ other than kidney.
Positive HBsAg test
Pre-Transplant PRA >50% or historical PRA >75% Other protocol-defined inclusion/exclusion criteria may apply.