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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

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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)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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