Conversion Trial From Mycophenolate Mofetil (MMF) to Enteric-coated Mycophenolate Sodium (EC-MPS) in Stable Transplanted Patients Suffering From Gastrointestinal (GI) Adverse Events While on Mycophenolate Mofetil Therapy (MMF) Therapy

Novartis23 enrolled

Overview

This open, single arm, explorative study aims to investigate the evolution of gastrointestinal adverse events after switch from MMF to EC-MPS in organ transplanted patients suffering from gastrointestinal adverse events while on MMF therapy.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Kidney Transplantation Liver Transplantation

Interventions

Enteric-coated Mycophenolate sodium (EC-MPS)DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Kidney or liver transplanted patients * Currently under MMF therapy and currently suffering from upper or lower gastro-intestinal adverse events Exclusion Criteria: * Recent graft rejection before the study * Other pre-existing conditions that may cause gastro-intestinal complaints * Use of other drugs known to cause gastro-intestinal complaints Other protocol-defined inclusion/exclusion criteria may apply

Locations (1)

Novartis

Basel, Switzerland

Outcomes

Primary Outcomes

Gastro-intestinal adverse events before switch versus 3 months after switch

Secondary Outcomes

Time to the first biopsy-proven rejection after conversion.

Severity of biopsy-proven rejections after conversion.

Proportion of patients who had graft loss after conversion.

Frequency of adverse events

Frequency of infections

Data from ClinicalTrials.gov

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