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

• Status: Unknown status
• Trial end date: 0000-00-00
• Target enrollment: 20
• Participant gender: Both

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanderbilt University
• Collaborator: Novartis Pharmaceuticals
• Treatments: Mycophenolate mofetil; Mycophenolic Acid
• Last Updated: 2010-12-16

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