Patients with end stage kidney disease who will undergo renal transplantation MedDRA version: 7.0 Level: LLT Classification code 10014646
Conditions
Sponsors
Astellas Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patients aged between 18 and 65 years. 2.Female patients of child bearing potential must have a negative serum pregnancy test prior to enrolment and must agree to practice effective birth control during the study. 3.Patients receiving a kidney transplant from a cadaveric donor or a living non HLA identical donor between 5 and 65 years of age with compatible AB0 blood type. 4.Patients with end stage kidney disease who are suitable candidates for primary renal transplantation or re-transplantation (unless the graft was lost because of immunological reasons within 12 months). 5.Patients capable of understanding the purpose and risks of the study, who have been fully informed and have given written informed consent to participate in the study. 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.Patients receiving or having previously received an organ transplant other than a kidney. 2.Patients with a high immunological risk, defined as a PRA grade >50% in the previous 6 months and/or with a previous graft survival of less than 12 months due to immunological reasons. 3.Cold ischaemia time of the donor kidney >30 hours. 4.Patients receiving a graft from a non-heart-beating donor other than of Maastricht category 3 (withdrawn of support awaiting cardiac arrest). 5.Patients allergic or intolerant to HCO-60 or structurally related compounds, steroids, macrolide antibiotics, mycophenolate mofetil or tacrolimus. 6.Patients with malignancies or a history of malignancy within the last 5 years, with the exception of those with basalioma or squamous cell carcinoma of the skin that has been treated successfully. 7.Patients with significant, uncontrolled concomitant infections and/or severe diarrhoea, vomiting, active upper gastrointestinal tract malabsorption or active peptic ulcer. 8.Patients with significant liver disease, defined as having continuously elevated SGPT/ALT and/or SGOT/AST and/or total bilirubin levels during the past 28 days of = 2 times the upper value of the normal range of the investigational site. 9.Patients with liver cirrhosis. 10.Patients requiring initial sequential or parallel therapy with immunosuppressive antibody preparation(s). 11.Patients with any form of substance abuse, psychiatric disorder or condition which, in the opinion of the investigator, may complicate communication with the investigator. 12.Patients participating or having participated in another clinical trial and/or those taking or having taken an investigational/non-registered drug in the past 28 days. 13.Patients requiring ongoing dosing with a systemic immunosuppressive drug prior to transplantation. Low dose steroids (<20 mg/day prednisolone equivalent) is acceptable. 14.Patients who are pregnant or breast-feeding. 15.Patients or donors known to be HIV positive. 16.Patients unlikely to comply with the visits scheduled in the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The study aims to evaluate and to compare the efficacy and safety of a triple modified release tacrolimus FK506E (MR4) / MMF / steroid regimen with a triple standard tacrolimus FK506 / MMF / steroid regimen in patients undergoing kidney transplantation. It shall be demonstrated that FK506E (MR4) is non-inferior to FK506 with regards to the primary endpoint.;Secondary Objective: ;Primary end point(s): Event rate of patients with biopsy-proven acute rejection within the first 24 weeks following transplantation | — |
Countries
Czech Republic, Finland, Hungary, Italy, Sweden
Outcome results
None listed