Prophylaxis of rejection in recipients of first or second cadaveric, living unrelated or living related kidney transplants
Conditions
Interventions
Trade Name: Myfortic 180 mg
Product Name: Myfortic
Product Code: ERL 080A
Pharmaceutical Form: Gastro-resistant tablet
Current Sponsor code: ERL080A
Other descriptive name: Myfortic
Concentration unit
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males or females, aged between 18 and 65 years 2. Recipients of first or second 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 (Visit 1), and are required to practice an approved method of birth control for the duration of the study and for a period of 3 months 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Graft loss due to immunological reasons in the first year after the first transplantation (in case of secondary transplantation) 2. Multi-organ recipients (e.g., kidney and pancreas) or previous transplant with any other organ, different from kidney 3. Patients receiving a kidney from a non-heart beating donor 4. Patients who are recipients of A-B-O incompatible transplants 5. Patients with a current peak PRA of > 10% 6. Patients with already existing antibodies against the HLA-type of the receiving transplant 7. Patients with any known hypersensitivity to mycophenolic acid or cyclosporine micro-emulsion, or other components of the formulations (e.g. lactose, see also SmPCs) 8. Use of other investigational drugs or a non-protocol immunosuppressant at randomization, or within 30 days or 5 half-lives prior to randomization, whichever is longer 9. Patients with thrombocytopenia (platelets 3 times UNL) 14. 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) 15. Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, unless they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels >40 mIU/m or 6 weeks post surgical bilateral oophorectomy with or without hysterectomy or are using one or more of the following acceptable methods of contraception: surgical sterilization (e.g., bilateral tubal ligation, hysterectomy), hormonal contraception (implantable, patch, oral), and double- barrier methods (any double combination of: IUD, male or female condom with spermicidal gel, diaphragm, sponge, cervical cap). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. Reliable contraception should be maintained throughout the study and for 3 months after study drug discontinuation 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). 19. Patients with chronic bowel inflammatory disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The primary efficacy variable is the proportion of patients with treatment failure defined as biopsy-proven acute rejection (BPAR), graft loss (GFL) or death at 6 months post-transplantation. ;Main Objective: The main aim of the study is to confirm the hypothesis than an initially intensified dosing regimen of mycophenolic acid administered as Myfortic® during the first 6 weeks post transplantation will provide therapeutical benefit as compared to a standard dosing regimen of Myfortic®, and is as safe and well-tolerated as the standard dosing regimen of Myfortic®.;Secondary Objective: To compare proportion of patients with treatment failure (defined as biopsy proven rejection, graft failure or death) at days 21 and 84 post-transplantation. To compare renal function as assessed by serum creatinine and glomerular filtration rate. To compare safety/tolerability as the proportion of patients with Myfortic® dose reductions and interruptions due to AEs, within 6 months post-transplantation. To explore changes in patient-reported gastro intestinal symptom burden using the Gastrointestinal Symptom Rating Scale (GSRS) total score at visits baseline, day 10, day 21, day 56, and day 84 post-transplantation. To explore changes in patient-reported health status measured by EQ-5D in at visits baseline, day 10, day 21, day 56, day 84 and day 180 post-transplantation. To compare the proportion of patients with treatment failure between treatment arms combining this study data with the data from CERL080ADE12 and with in-house historical data. | — |
Countries
Austria, Belgium, Italy, Sweden
Outcome results
None listed