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

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ClinicalTrials.gov Identifier: NCT01044667
Recruitment Status : Terminated (poor enrollment and lack of study staff)
First Posted : January 8, 2010
Last Update Posted : February 20, 2018
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Vanderbilt University Medical Center ( Vanderbilt University )

Brief Summary:
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 or disease Intervention/treatment Phase
Lung Transplantation Behavioral: GI and Quality of Life Assessment Not Applicable

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. The 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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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)
Study Start Date : January 2010
Actual Primary Completion Date : July 2012
Actual Study Completion Date : December 2012


Arm Intervention/treatment
Patients taking Myfortic
Lung transplant patients converted from MMF to Myfortic as part of standard of care treatment will have GI and Quality of Life assessments done at the time of conversion to Myfortic and at 60 days, 90 days and 180 days.
Behavioral: GI and Quality of Life Assessment



Primary Outcome Measures :
  1. Change in Gastrointestinal Quality of Life Index (GIQLI), Baseline to 60 days: [ Time Frame: Change from Baseline to 60 days ]
    Change in GIQLI after conversion from MMF to Myfortic

  2. Change in SF-36 Health Survey, Baseline to 60 days [ Time Frame: Change from Baseline to 60 days ]
    Change in SF-36 Health Survey after conversion from MMF to Myfortic

  3. Change in EQ-5D Health Questionnaire, Baseline to 90 days [ Time Frame: Change from Baseline to 60 days ]
    Change in EQ-5D Health Questionnaire after conversion from MMF to Myfortic


Secondary Outcome Measures :
  1. Gastrointestinal Quality of Life Index (GIQLI) [ Time Frame: Day 90 and Day 180 ]
    Change in GIQLI after conversion from MMF to Myfortic

  2. SF-36 Health Survey [ Time Frame: Day 90 and Day 180 ]
    Change in SF-36 Health Survey after conversion from MMF to Myfortic

  3. EQ-5D Health Questionnaire [ Time Frame: Day 90 and Day 180 ]
    Change in EQ-5D Health Questionnaire after conversion from MMF to Myfortic



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01044667


Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232-4753
Sponsors and Collaborators
Vanderbilt University
Novartis Pharmaceuticals
Investigators
Principal Investigator: Eric Lambright, MD Vanderbilt University Medcial Center

Responsible Party: Vanderbilt University
ClinicalTrials.gov Identifier: NCT01044667     History of Changes
Other Study ID Numbers: Myfortic 091423
First Posted: January 8, 2010    Key Record Dates
Last Update Posted: February 20, 2018
Last Verified: February 2018

Additional relevant MeSH terms:
Mycophenolic Acid
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action