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OpenTrials
Completed

NCT Number: NCT00619216

Myfortic Conversion Trial in OLT Recipients With GI Intolerance

Liver transplant patients often require multimodal immunosuppressive therapy to minimize their risk for rejection. In our regimen, MMF (mycophenolate mofetil) is often added to lower the side effects of the calcineurin inhibitors. Unfortunately the literature reports 20% up to as many as 40% of patients have GI intolerance to MMF. At our Center, approximately 30% of patients have intolerance to MMF, thereby mitigating our ability to use this agent. The primary objective of this study is to assess the tolerability of myfortic in combination with Neoral or Tacrolimus as determined by the GSRS (Gastrointestinal Symptom Rating Scale) after conversion from MMF in maintenance liver transplant patients with GI intolerance within 3 months.

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Key information

Conditions

GI Disturbance

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of North Carolina-Chapel Hill

Chapel Hill, North Carolina, 27599-7211, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Recipients of orthotopic liver transplant at least 8 weeks post transplant
  • Mild and/or moderate GI complaints directly related to MMF

Exclusion criteria

  • Multi-organ transplant recipients
  • Evidence of graft rejection within 14 days prior to Baseline visit

Treatment and study plan

Mycophenolic Acid (Myfortic)

Drug

Equimolar conversion from mycophenolate mofetil to mycophenolic acid

Other names: Cellcept; Myfortic

Primary outcomes

  1. Evaluation of GI symptoms using GSRS, GIQLi, and SF-12 after conversion to Myfortic

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • Novartis Pharmaceuticals

Registry information

Official study title

A Three-Month, Open-Label, Two Cohort Study to Investigate the Safety and Tolerability of Myfortic in Combination With Neoral (Cyclosporin) or Prograf (Tacrolimus) in Liver Transplant Recipients With GI Intolerance

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Feb 20, 2008
Registry last updated
Jun 3, 2011

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.

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