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

NCT01044667 | Terminated

• 1 other identifier: Myfortic 091423
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Transplantation

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (3)

• Gastrointestinal Quality of Life Index (GIQLI)

  Day 90 and Day 180

• SF-36 Health Survey

  Day 90 and Day 180

• EQ-5D Health Questionnaire

  Day 90 and Day 180

Study Arms (1)

Patients taking Myfortic

OTHER

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

Interventions

GI and Quality of Life Assessment BEHAVIORAL

Patients taking Myfortic

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University: lead
• Novartis Pharmaceuticals: collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232-4753, United States

Location

Study Officials

• Eric Lambright, MD

  Vanderbilt University Medcial Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2010
• First Posted: January 8, 2010
• Study Start: January 1, 2010
• Primary Completion: July 1, 2012
• Study Completion: December 1, 2012
• Last Updated: February 20, 2018

Record last verified: 2018-02

Locations

US (1)