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

ovartis Pharma GmbH0 个研究点开始时间: 2006年1月10日最近更新: 2012年4月24日

试验速览

暂无简介。

•- 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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 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

发起方

ovartis Pharma GmbH