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 Pharmaceuticals144 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

144

Conditions

Kidney de Novo Transplant

Interventions

Enteric-coated Mycophenolate sodium (EC-MPS)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

biopsy proven acute rejection incidence at 1 year post-transplantation

Secondary Outcomes

Incidence of biopsy proven acute rejection episodes at 6 months

Incidence of treated rejection episodes at 6 months and 1 year

Incidence of steroid-resistant episodes at 6 months and 1 year

Patient and graft survival at 1 year

Cardiovascular profile (as measured by Cholesterol, HbA1, Glucose, incidence of HTA)

Percentage of patients free from steroids at 6 months and 1 year

Treatment safety