Skip to main content
OpenTrials
Completed

NCT Number: NCT00150020

Safety and Tolerability of Enteric-Coated Mycophenolate Sodium (EC-MPS) in Renal Transplant Patients With GI Intolerance

The aim of this study is to evaluate the safety and tolerability of EC-MPS in maintenance renal transplant patients who experience gastrointestinal (GI) intolerance due to adverse events associated with mycophenolate mofetil (MMF) and were converted to EC-MPS.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Renal Transplantation

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis

East Hanover, New Jersey, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males and females aged 18-75 years.
  • Recipients of first or secondary cadaveric, living unrelated or living related kidney transplant.
  • Recipients who are at least 4 weeks post renal transplantation.
  • Patients currently receiving MMF (all dosages are allowed), cyclosporine microemulsion, its generic equivalent, cyclosporine USP (modified) or tacrolimus with or without corticosteroids as part of their immunosuppressive regimen for at least 2 weeks.
  • Patients with mild and/or moderate GI complaints (e.g. upper abdominal pain, dyspepsia, anorexia, nausea, vomiting) with or without diarrhea.

Exclusion criteria

  • Multi-organ patients (e.g. kidney and pancreas) or previous transplant with any other organ different from kidney (secondary kidney transplant is allowed).
  • Evidence of graft rejection, treatment of acute rejection or unstable renal function within 4 weeks prior to baseline visit.
  • Patients who have received an investigational immunosuppressive drug within 4 weeks prior to study entry.

Other protocol-defined inclusion/exclusion criteria may apply.

Treatment and study plan

Enteric-Coated Mycophenolate Sodium (EC-MPS)

Drug

Primary outcomes

  1. Tolerability of EC-MPS in combination with CsA-ME or tacrolimus as determined by gastrointestinal symptom rating scale (GSRS) after conversion from MMF in maintenance renal transplant patients with GI intolerance

    Time frame: within 3 months

Secondary outcomes

  1. Safety of EC-MPS in combination with CsA-ME or tacrolimus as determined by incidence and severity of GI adverse events

    Time frame: within 3 months

  2. Tolerability of EC-MPS in combination with CsA-ME or tacrolimus as determined by gastrointestinal symptom rating scale (GSRS)

    Time frame: within 1 month

  3. Efficacy of EC-MPS in combination with CsA-ME or tacrolimus as measured by the incidence of biopsy-proven acute rejection

    Time frame: within 3 months

  4. Tolerability of EC-MPS in combination with CsA-ME or tacrolimus by comparing the two study groups

    Time frame: after 3 months

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

Safety and Tolerability of Enteric-Coated Mycophenolate Sodium in Renal Transplant Patients With GI Intolerance

Important dates

Study start
2004
Primary completion
2006
First posted
Sep 8, 2005
Registry last updated
Jan 24, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.