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

Novartis

Status and phase: Completed; Phase 4

Conditions: Liver Transplantation; Kidney Transplantation

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00149942

CERL080ABE01

Details and patient eligibility

About

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.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)