NCT00619216

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 20, 2008

Completed
10 days until next milestone

Study Start

First participant enrolled

March 1, 2008

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

June 3, 2011

Status Verified

June 1, 2011

Enrollment Period

1.8 years

First QC Date

February 7, 2008

Last Update Submit

June 1, 2011

Conditions

GI Disturbance

Keywords

Orthotopic Liver Transplant Recipients with GI disturbance

Outcome Measures

Primary Outcomes (1)

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

    3 months

Interventions

Mycophenolic Acid (Myfortic)DRUG

Equimolar conversion from mycophenolate mofetil to mycophenolic acid

Also known as: Cellcept; Myfortic

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Recipients of Orthotopic Liver Transplants

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina-Chapel Hill

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

Location

MeSH Terms

Interventions

Mycophenolic Acid

Intervention Hierarchy (Ancestors)

CaproatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty AcidsLipids

Study Officials

  • David Gerber, MD

    UNC-Chapel Hill Department of Surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 7, 2008

First Posted

February 20, 2008

Study Start

March 1, 2008

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

June 3, 2011

Record last verified: 2011-06

Locations

US(1)