Patients with end stage kidney disease who will undergo primary renal transplantation or retransplantation. MedDRA version: 7.0 Level: LLT Classification code 10014646
Conditions
Interventions
Trade Name: Prograf 0.5 mg
Product Name: Prograf
Product Code: FK506
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Tacrolimus
CAS Number: 109581-93-3
Current Sponsor code: FK506
Concentratio
Sponsors
Fujisawa GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Male or female patients between 18 and 60 years of age. 2.Female patient of childbearing potential agrees to maintain effective birth control during the study and 3 months thereafter. 3.Patient has end stage kidney disease and is a suitable candidate for primary renal transplantation or retransplantation (unless the graft was lost from rejection within 12 months). 4.Patient is receiving a kidney transplant from a cadaveric or living (not HLA identical) donor with compatible AB0 blood type. 5.Patient is capable of understanding the purpose and risks of the study, has been fully informed and has given written informed consent. Patient unable to write and/or read but who fully understands the oral information given by the investigator (or nominated representative) has given oral informed consent witnessed in writing by an independent person. 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. Patient has a high immunological risk, defined as a PRA grade >50% in the previous 6 months and / or having a previous graft survival 350mg/dL, 9.1 mmol/dL). Patient with controlled hyperlipidemia is acceptable. 6. Patient is pregnant or breastfeeding. 7. Patient is allergic or intolerant to corticosteroids, macrolide antibiotics, mycophenolate mofetil, mycophenolic acid, tacrolimus, sirolimus or to the excipients of the study medication. 8. Patient requires ongoing dosing with corticosteroids. 9. Patient requires initial sequential or parallel therapy with immunosuppressive antibody preparation(s) or prohibited medication (see section 7.6). 10. Patient or donor is known to be HIV positive. 11. Patient with malignancy or history of malignancy, except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully. 12. Patient has significant, uncontrolled concomitant infections and/or severe diarrhoea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer. 13. Patient is participating or has participated in another clinical trial and/or is taking or has been taking an investigational drug in the past 30 days. 14. Patient has previously received or is receiving an organ transplant other than kidney. 15. Patient has been previously enrolled in this study. 16. Patient is unlikely to comply with the visits scheduled in the protocol. 17. Patient has any form of substance abuse, psychiatric disorder or condition which, in the opinion of the investigator, may invalidate communication with the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective of this study is to compare the two therapy regimens (Arm 1: tacrolimus + sirolimus + corticosteroids, Arm 2: tacrolimus + MMF + corticosteroids)with regard to renal function by using calculated creatinine clearance. The aim is to demonstrate that Arm 1 is non-inferior to Arm 2 with regard to the primary endpoint.;Secondary Objective: The secondary objectives are to compare the efficacy and safety profiles of the two therapy regimens (Arm 1: tacrolimus + sirolimus + corticosteroids, Arm 2 : tacrolimus + MMF + corticosteroids);Primary end point(s): The primary efficacy endpoint of this study will be the renal function measured by calculated creatinine clearance at month 6 (by using the Cockcroft formula). | — |
Countries
Hungary, Italy, Spain, Sweden
Outcome results
None listed