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

Lung Transplantation Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01044667
• Other study ID #: Myfortic 091423
• Status: Terminated
• Phase: N/A
• First received: January 6, 2010
• Last updated: February 16, 2018
• Start date: January 2010
• Est. completion date: December 2012

Study information

• Verified date: February 2018
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: December 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Transplantation

Intervention

Behavioral:
• GI and Quality of Life Assessment

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University	Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Gastrointestinal Quality of Life Index (GIQLI), Baseline to 60 days:	Change in GIQLI after conversion from MMF to Myfortic	Change from Baseline to 60 days
Primary	Change in SF-36 Health Survey, Baseline to 60 days	Change in SF-36 Health Survey after conversion from MMF to Myfortic	Change from Baseline to 60 days
Primary	Change in EQ-5D Health Questionnaire, Baseline to 90 days	Change in EQ-5D Health Questionnaire after conversion from MMF to Myfortic	Change from Baseline to 60 days
Secondary	Gastrointestinal Quality of Life Index (GIQLI)	Change in GIQLI after conversion from MMF to Myfortic	Day 90 and Day 180
Secondary	SF-36 Health Survey	Change in SF-36 Health Survey after conversion from MMF to Myfortic	Day 90 and Day 180
Secondary	EQ-5D Health Questionnaire	Change in EQ-5D Health Questionnaire after conversion from MMF to Myfortic	Day 90 and Day 180