Extension Study of the Safety and Efficacy of Enteric-coated Mycophenolate Sodium in Kidney Transplant Recipients

Novartis183 enrolled

Overview

The objective of this extension study is to allow patients being treated with enteric-coated mycophenolate sodium (core study CERL080A2405LA01) to continue on the same treatment and to assess the long-term safety of EC-MPS.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

183

Conditions

Renal Transplantation

Interventions

Enteric-Coated Mycophenolate Sodium (EC-MPS)DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * All patients who completed study CERL080A2405-LA01 and who are willing to continue treatment with Enteric-Coated Mycophenolate Sodium. Exclusion Criteria: * Other protocol-defined inclusion / exclusion criteria may apply

Outcomes

Primary Outcomes

Safety parameters and graft function in maintenance renal transplant recipients.

Secondary Outcomes

Incidence of acute rejection episodes and graft survival in maintenance renal transplant recipients.

Data from ClinicalTrials.gov

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