A Gastrointestinal Quality of Life Study in Lung Transplant Recipients Converted From Mycophenolate Mofetil to Myfortic

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Vanderbilt University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01044667
First received: January 6, 2010
Last updated: December 16, 2010
Last verified: December 2010
  Purpose

The primary objective of this study is to evaluate gastrointestinal (GI) symptoms and health related quality of life in lung transplant recipients converted from Mycophenolate Mofetil (MMF) to Myfortic as part of standard immunosuppressive therapy.


Condition Intervention Phase
Lung Transplantation
Drug: Myfortic
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Reduced Gastrointestinal Complaints and Improved Quality of Life in Lung Transplant Recipients Converted From Mycophenolate Mofetil (MMF) to Myfortic (Enteric-coated Mycophenolate Sodium, Ec-mps)

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • To evaluate GI symptoms and Health related quality of life in lung transplant recipients converted from MMF to Myfortic as part of standard immunosuppressive therapy.

Estimated Enrollment: 20
Study Start Date: January 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Myfortic Drug: Myfortic

Detailed Description:

Subjects administered MMF as part of their immunosuppression regimen after lung transplantation have a high incidence of GI symptoms related to the known side-effects of this drug. Previous studies have shown that GI symptoms are an important predictor of health related quality of life in other solid organ transplants (1). GI complications are common after lung transplant (2). We hypothesize that lung transplant patients converted from MMF to Myfortic will have significant reduction in severity of GI complaints. We also hypothesize that improvement in the severity of GI complaints will lead to an improved quality of life in these subjects. The study also includes data to evaluate the effect of GI complaints on health related quality of life.

Patients will complete questionnaires at each visit. Calls from the patients to the lung transplant center with GI complaints will be queried and documented on the case report form by the research nurse at each study visit. Similarly, hospital admissions for GI related complaints in the cohort will be documented. Symptom severity and health related quality of life will be assessed through the following questionnaires that have previously been validated in populations other than lung transplant (1). These questionnaires are selected specifically to capture the impact of GI complaints as related to the health related quality of life. The questionnaires that will be completed by the patient:

i.Gastrointestinal Quality of Life Index (GIQLI)

• The GIQLI is a 36-item questionnaire that assess the impact of GI distress on daily life

ii.SF-36 Health Survey • "The SF-36 Health Survey is a questionnaire that capture practical, reliable, and valid information about functional health and well-being from the patients' point of view" (4)

iii.EQ-5D Health Questionnaire

• "The EQ-5D is a standardized instrument for use as a measure of health outcome. It [EQ-5D] provides a simple descriptive profile and a single value for health status" (5)

Patients will complete the three questionnaires at 4 outpatient visits occurring:

  • when the patient comes in to an outpatient clinic visit after initial hospital discharge after lung transplantation with complaints of GI distress (DAY 1-Convert to Myfortic);
  • 60 DAYS;
  • 90 DAYS;
  • 180 Days
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ability and willingness to provide written informed consent and adhere to study regimen
  • Recipients who are 18-70 years of age
  • Patients who have undergone either single or double lung transplant are discharged on the standard MMF (no generic MMF will be used) therapy and complain of GI symptoms, thought to be related to their immunosuppressive regimen

Exclusion Criteria:

  • Patients who have GI complaints thought to be due to factors other than immunosuppressive regimen
  • Patients receiving steroid treatment for acute rejection
  • Women of childbearing potential who do not agree to use at least two acceptable forms of contraception prior to starting study drug, while taking study drug, and for 6 weeks after stopping study drug
  • Women who have a positive serum or urine pregnancy test at visit 1 and/or continuing through the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01044667

Contacts
Contact: Carla M Thomas, RN, BSN 615-936-0834 carla.thomas@vanderbilt.edu
Contact: Haley Hoy, Ph.D., ACNP 615-202-8576 haley.hoy@vanderbilt.edu

Locations
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232-4753
Contact: Carla M Thomas, RN, BSN    615-936-0834    carla.thomas@vanderbilt.edu   
Sponsors and Collaborators
Vanderbilt University
Novartis Pharmaceuticals
Investigators
Principal Investigator: Eric Lambright, MD Vanderbilt University Medcial Center
  More Information

No publications provided

Responsible Party: Dr. Eric Lambright, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT01044667     History of Changes
Other Study ID Numbers: Myfortic 091423
Study First Received: January 6, 2010
Last Updated: December 16, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Mycophenolate mofetil
Mycophenolic Acid
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 21, 2014