Stable Pancreas-Kidney (SPK) Transplant Recipients MedDRA version: M15 Level: LLT Classification code 10023438
Conditions
Interventions
Trade Name: Myfortic 180 mg Filmtabletten
Product Name: Myfortic 180 mg Filmtabletten
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Mycophenolate sodium
Current Sponsor code: ERL080
Co
Sponsors
Novartis Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess if a switch from MMF to myfortic® results in improved GI- and/or health-related quality of life outcomes, and to determine the proportion of SPK transplant recipients who are experiencing any GI complaints under MMF-based immunosuppressive treatment.;Secondary Objective: Secondary objective of this study is to determine the proportion of enrolled SPK transplant recipients who are experiencing at least minor GI symptoms under MMF-based immunosuppressive therapy. A further secondary objective is to identify and evaluate the impact of immunosuppressive-induced GI symptoms on patient’s perception of symptom severity and HRQL;Primary end point(s): Primary endpoint is the comparison of the single answers of the patients to the specified questions in different questionnaires (gastrointestinal specific and quality-of-life specific) before and 6-8 weeks after conversion from MMF to myfortic. | — |
Countries
Germany
Outcome results
None listed