Measurement of Patient Reported Gastrointestinal (GI) and Health-related Quality of Life (HRQL) Outcomes in Simultaneous Pancreas-Kidney Transplant Recipients - MyWay

ovartis Pharma GmbH0 sitesJanuary 10, 2006

Overview

No summary available.

Registry

who.int

Start Date

January 10, 2006

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

ovartis Pharma GmbH

•\- Received pancreas\-kidney transplant at least 3 months prior to study enrollment;
•\- Receiving immunosuppressive regimen that includes MMF in combination with other immunosuppressive drugs (i.e., a calcineurin inhibitor, a mTOR inhibitor, steroids at least three months at time of study enrollment);
•\- Receiving MMF for at least 1 month prior to enrollment (max. dose 2000 mg/d);
•\- Eligible and willing to convert to myfortic®;
•\- Stable on current immunosuppressive regimen for at least 1 month prior to enrollment;
•\- At least 18 years of age.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range

•\- If applicable, GI symptoms assumed or known to be caused by other drugs or infections (e.g. oral biphosphonates induced, infectious diarrhea);
•\- Acute rejection \< 4weeks prior to study enrollment;
•\- Woman of child\-bearing potential who is planning to become pregnant or is pregnant and/or lactating or who is unwilling to use effective means of contraception;
•\- Presence of psychiatric illness (i.e., schizophrenia, major depression) that, in the opinion of the site investigator, would interfere with study requirements;
•\- Undergoing acute medical intervention or hospitalization, excluding hospitalization due to elective diagnostic procedures