Patients with end stage kidney disease who will undergo primary renal transplantion or retransplantation MedDRA version: 7.0 Level: LLT Classification code 10014646
Conditions
Interventions
Trade Name: Prograf
Product Name: Prograf
Product Code: FK506
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Tacrolimus
CAS Number: 109581-93-3
Current Sponsor code: FK506
Concentration unit:
Sponsors
Fujisawa GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 Male or female patients minimum 60 years of age 2 Patient has end stage kidney disease and is a suitable candidate for primary renal transplantation or retransplantation 3. Patient is receiving a kidney transplant, from a cadaveric or living donor (not HLA identical) with compatible ABO blood type 4. Patient has been fully informed and has given written informed consent according to ICH-GCP. 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 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patient has an immunological high risk, defined as a PRA grade >50% 2. Cold ischemia time of the donor kidney greater than 30 hours 3. Patient has significant liver disease, defined as having during the past 30 days continuously elevated ASAT (SGOT) and/or ALAT (SGPT) levels greater than 2 times the upper value of the normal range of the investigational site or is receiving a graft from a hepatitis C or B positive donor 4. Patient is allergic or intolerant to corticosteroids, macrolide antibiotics, mycophenolate mofetil, mycophenolic acid, tacrolimus, basiliximab or to the excipients of the study medication 5. Patient requires ongoing dosing with corticosteroids 6. Patient requires initial sequential or parallel therapy with immunosuppressive antibody preparation(s) or prohibited medication (see section 7.4 of protocol) 7. Patient or donor is known to be HIV positive 8. Patient with malignancy or history of malignancy, except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully 9. Patient has significant, uncontrolled concomitant infections and/or severe diarrhoea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer 10. 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 11. Patient has previously received or is receiving an organ transplant other than kidney 12. Patient has been previously enrolled in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To compare the efficacy and safety profiles of the two therapy regimens (Arm 1: Delayed Tacrolimus + MMF+ Basiliximab + Corticosteroids (1 week), Arm 2: Tacrolimus + MMF + Corticosteroids (3 months)). ;Main Objective: To compare renal function as well as incidence of renal dysfunction, patient death, graft loss or first biopsy proven acute rejection within the first 6 months after transplantation for the two therapy regimens (Arm 1: Delayed Tacrolimus + MMF+ Basiliximab + Corticosteroids (1 week), Arm 2: Tacrolimus + MMF + Corticosteroids (3 months)). The aim is to demonstrate that Arm 1 is non-inferior to Arm 2 with regard to the primary endpoint.;Primary end point(s): A two step testing strategy will be applied for the two primary endpoints. The first primary efficacy endpoint of this study will be the renal function measured by calculated creatinine clearance at month 6, determined from the serum creatine using the Cockcroft formula. If the result of the test for the first primary endpoint is statistically significant, then the composite endpoint can also be tested in a confirmatory way. The composite endpoint is the incidence of death, graft loss or acute rejection within the first 6 months after transplantation and incidence of renal dysfunction defined as a calculated creatinine clearance value of =40 ml/min/1.73 m2 at month 6. | — |
Countries
Spain
Outcome results
None listed