immunosuppression Renal transplantation
Conditions
Interventions
Study patients will be randomized to the following regime in both stratum A and
stratum B in a 1:1ratio. Arm 1: Basiliximab (B) induction (20 mg iv on days 0
and 4), prednisolone taper to 5 mg at 3
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
65 Years to 99 Years
Inclusion criteria
Inclusion criteria: nclusion criteria 1. Written informed consent must be obtained before any assessment is performed 2. Male or female subject >= 65 years old 3. Subject randomized within 24 hours of completion of transplant surgery 4. Stratum A: Recipient of a primary (or secondary, if first graft is not lost due to immunological reasons) renal transplant from a deceased donor aged 65 years or older 5. Stratum B: Recipient of a primary (or secondary, if first graft is not lost due to immunological reasons) renal transplant from a deceased donor aged below 65 years or a living donor of any age
Exclusion criteria
Exclusion criteria: Exclusion criteria for both stratum A and B 1. Subject is a multi-organ transplant recipient 2. Recipient of ABO incompatible allograft or CDC cross-match positive transplant 3. Subject at high immunological risk for rejection as determined by local practice for assessment of anti-donor reactivity 4. Recipient of a kidney with a CIT > 24 hr 5. Recipients of a kidney from an HLA identical related living donor 6. Known intolerability for one or more of the study drugs 7. Subject who is HIV positive 8. HBsAg and/or a HCV positive subject with evidence of elevated LFTs (ALT/AST levels >= 2.5 times ULN). Viral serology results obtained within 6 months prior to randomization are acceptable * 9. Recipient of a kidney from a donor who tests positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or anti-hepatitis C virus (HCV) 10. Subject with a BMI greater than 35 11. Subject with severe systemic infections, current or within the two weeks prior to randomization 12. Subject requiring systemic anticoagulation that cannot be temporarily interrupted and which would preclude renal biopsy 13. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases 14. Subject with severe restrictive or obstructive pulmonary disorders 15. Subject with severe hypercholesterolemia or hypertriglyceridemia that cannot be controlled 16. Subject with white blood cell (WBC) count
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primay outcome is succesfull transplantation. As outcome is expected to be markedly different in stratum A and stratum B, different primary outcome criteria will be used. We have defined successful transplantation as our primary outcome variable combining patient and graft survival with a minimum level of renal function. In our opinion this endpoint combines the most relevant outcomes for the patient. Stratum A: Primary endpoint: successful transplantation at 1 year after transplantation defined as: absence of graft or patient loss in the presence of an eGFR above 30 ml/min/1.73m2. Stratum B: Primary endpoint: successful transplantation at 1 year after transplantation defined as absence of graft or patient loss in the presence of an eGFR above 45 ml/min/ 1.73m2. Both strata are pooled for analysis. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes both strata: • Incidence of individual endpoints of death, graft loss, rejection eGFR below 30 or 45 ml/min/ 1.73m2 rejection at Months 12 and 24. • Rejection treatment and type of rejection treatment • The evolution of renal function (eGFR) over time by slope analysis. • The incidence of adverse events, serious adverse events and adverse reactions • The incidence of clinically relevant infections, new onset diabetes mellitus and malignancies • Presence of frailty at 3, 12 and 24 months after transplantation and change in frailty from baseline •Presence of markers for immunosenescence at 12 and 24 months and changes from baseline •hrQOL at 3, 12 and 24 months and changes from baseline. •Development of donor specific antibodies. | — |
Countries
Netherlands
Outcome results
None listed