De novo renal 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
Current Sponsor code: ERL080
Concentra
Sponsors
Novartis Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria 1. Males or females, aged between 18 and 70 years 2. Recipients of de novo cadaveric, living unrelated or living related kidney transplants 3. Females capable of becoming pregnant must have a negative serum pregnancy test within 7 days prior to or at Baseline, and are required to practice an approved method of birth control for the duration of the study and for a period of 6 weeks following discontinuation of study medication, even where there has been a history of infertility 4. Patients who are willing and able to participate in the study and from whom written informed consent has been obtained 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: Exclusion Criteria 1. More than one previous renal transplantation 2. Graft loss due to immunological reasons in the first year after transplantation (in case of secondary transplantation) 3. Multi-organ recipients (e.g., kidney and pancreas) or previous transplant with any other organ, different from kidney 4. Patients receiving a kidney from a non-heart beating donor 5. Patients who are recipients of A-B-O incompatible transplants 6. Patients with a current peak PRA of > 50% 7. Patients with already existing antibodies against the HLA-type of the receiving transplant 8. Patients with any known hypersensitivity to mycophenolic acid or cyclosporine A, or other components of the formulations (e.g. lactose, see also SmPCs) 9. Patients who have received an investigational immunosuppressive drug within four weeks prior to study entry (Baseline visit) 10. Patients with thrombocytopenia (platelets 3 times UNL) 15. Females of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating, who are unwilling to use effective means of contraception (see also section 8.2 in the protocol) 16. Presence of a clinically significant infection requiring continued therapy, severe diarrhea, active peptic ulcer disease, or uncontrolled diabetes mellitus that in the opinion of the investigator would interfere with the appropriate conduct of the study 17. Evidence of drug or alcohol abuse 18. Patients receiving drugs known as strong inhibitors or inducers of CsA and/or Myfortic® drug metabolism (for drug interactions see Appendix 3 to this protocol).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This exploratory study will be conducted in two phases to compare in terms of safety and efficacy an initially intensified dosing regimen of Myfortic® versus a standard dosing regimen of Myfortic®. Primary objective of Phase I: Comparison of MPA exposure (AUC [0-12]) of two different Myfortic® dosing regimens including time to achieve an MPA AUC of > 40 mg*h/L. Primary objective of Phase II: To assess time to occurrence of treatment failures, defined as a composite endpoint of biopsy proven acute rejection, graft loss, and death, loss to follow up and discontinuations from study drug treatment due to lack of efficacy or toxicity (at least one condition must be present) during the first 6 months post transplantation or at month 6 post transplantation.;Secondary Objective: Phase I: • To assess safety and tolerability •To assess the incidence of BPAR and Graft Loss •To assess the pharmacokinetic profile of Myfortic® •To assess IMPDH activity Phase II: • To assess occurrence of treatment failures at additional timepoints day 28 and day 84 • To assess rates of events for the following endpoints on day 28, 84, and 180: - Treated biopsy-proven acute rejection (BPAR), death or graft loss - Treated BPAR, death, graft loss or loss to follow up - Death, graft loss or loss to follow-up - Treated acute rejection - Treated acute rejection, death, graft loss, or loss to follow up • To assess all individual components of the composite endpoint “treatment failure” • To assess time to “event” for the composite endpoint as well as all individual components of that endpoint “treatment failure” • To assess renal function • To assess safety and tolerability ;Primary end point(s): Primary endpoint of Phase I is the MPA exposure of two different Myfortic® dosing regimens at different timepoints after transplantation. Primary endpoint of Phase II is the time to occurrence of treatment failures up to or at Month 6 with two different Myfortic® dosing regime | — |
Countries
Germany
Outcome results
None listed