GI Disturbance
Conditions
Keywords
Orthotopic Liver Transplant Recipients with GI disturbance
Brief summary
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.
Interventions
Equimolar conversion from mycophenolate mofetil to mycophenolic acid
Sponsors
Novartis Pharmaceuticals
University of North Carolina, Chapel Hill
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of GI symptoms using GSRS, GIQLi, and SF-12 after conversion to Myfortic | 3 months |
Countries
United States
Outcome results
None listed