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

Conditions: Stable Pancreas-Kidney (SPK) Transplant Recipients
MedDRA version: M15Level: LLTClassification code 10023438

Registration Number: EUCTR2005-001144-23-DE

Lead Sponsor: ovartis Pharma GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

- 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

Exclusion Criteria

- 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