Extension Study of Enteric-coated Mycophenolate Sodium With Short-term or no Steroid Use Compared With Enteric-coated Mycophenolate Sodium With Standard Steroid Therapy in de Novo Kidney Recipients

Novartis79 enrolled

Overview

The objective of this study is to assess the long-term safety and tolerability of EC-MPS on the patients who completed the core study and wish to continue treatment on EC-MPS.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Renal Transplantation

Interventions

Enteric-coated Mycophenolate sodium (EC-MPS)DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria/ Exclusion Criteria * All patients who completed the core study and who are still receiving the EC-MPS and wish continue treatment with EC-MPS and from whom written informed consent has been obtained Other protocol-defined exclusion criteria may apply.

Outcomes

Primary Outcomes

Safety and tolerability of enteric-coated mycophenolate sodium based on adverse event (AE) reporting.

Data from ClinicalTrials.gov

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