Measurement of Patient Reported Outcomes in Renal Transplant Patients With And Without Gastrointestinal (GI) Symptoms (PROGIS)
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Open, Multi-centre, Non-interventional, Observational Study to Characterize the Impact That GI Complaints Have on Patient-reported Outcomes in Patients Who Have Had a Renal Transplant. Patients Will be Evaluated at Visit 1 and Then Again After 4 (+2) Weeks (Visit 2)
Study Start Date
Primary Completion Date
Study Completion Date
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Kidney transplanted Patients currently on MMF who have GI symptoms and will be converted to EC-MPS treatment and patients currently on MMF without GI symptoms who will continue with MMF therapy.
Patient received kidney transplant at least 1 month prior to study with MMF as a part of the treatment for at least 2 weeks.
Eligible to convert to myfortic because of GI complaints or not currently experiencing GI complaints and stable on current immunosuppressive regimen.
At least 18 years of age;
Willing to provide written informed consent; and
Able to meet all study requirements including completing paper questionnaires and completing two study visits.
GI symptoms assumed or known not be caused by MPA therapy and have recent acute rejection at least 1 week prior to the study.
Breast-feeding or pregnant woman.
Patients with psychiatric illness.
Underlying acute medical intervention or hospitalization
Receiving investigational drug within 30days prior to study.