The OPTIMIzE study;OPen label multicenter randomized Trial comparing standard IMmunosuppression with tacrolimus and mycophenolate mofetil with a low exposure tacrolimus regimen In combination with everolimus in de novo renal transplantation in Elderly patients.

Conditions

kidney transplant

Brief summary

Incidence of individual endpoints of death, graft loss, eGFR below 30 or 45 ml/min/1.73m2 at Months 12 and 24, Incidence of treated biopsy-proven rejection (tBPAR), Rejection treatment and type of rejection treatment, The evolution of renal function (eGFR and creatinine clearance) over time by slope analysis, The incidence of adverse events, serious adverse events and adverse reactions, The incidence of clinically relevant infections, post transplantation diabetes mellitus, malignancies and cardiovascular events, Presence of frailty at 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 0, 12 and 24 months and changes from baseline, Development of donor-specific anti-HLA antibodies (DSA), Difference in illness perception at 0, 12 and 24 months and changes from baseline, Difference in BAASIS at 12 and 24 months, Difference in symptoms (DSI + MTSOSD-59) at 0, 12 nad 24 months and changes from baseline, Difference in iBOX predicted outcome at 3, 5 and 7 years

Related papers

No related papers found yet.

Interventions

DRUGPrednisolone 5mg Soluble Tablets

DRUGCertican 0

DRUG75 mg tablety

DRUGMycofenolaat mofetil Sandoz 250 mg

DRUGcapsules

DRUGhard

DRUGEnvarsus 0.75 mg prolonged-release tablets

DRUGSimulect 20 mg powder and solvent for solution for injection or infusion

DRUGCiclosporine Teva 25 mg

DRUGzachte capsules

Eligibility

Sex/Gender

All

Age

65 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Incidence of individual endpoints of death, graft loss, eGFR below 30 or 45 ml/min/1.73m2 at Months 12 and 24, Incidence of treated biopsy-proven rejection (tBPAR), Rejection treatment and type of rejection treatment, The evolution of renal function (eGFR and creatinine clearance) over time by slope analysis, The incidence of adverse events, serious adverse events and adverse reactions, The incidence of clinically relevant infections, post transplantation diabetes mellitus, malignancies and cardiovascular events, Presence of frailty at 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 0, 12 and 24 months and changes from baseline, Development of donor-specific anti-HLA antibodies (DSA), Difference in illness perception at 0, 12 and 24 months and changes from baseline, Difference in BAASIS at 12 and 24 months, Difference in symptoms (DSI + MTSOSD-59) at 0, 12 nad 24	—

Measure

Time frame

Incidence of individual endpoints of death, graft loss, eGFR below 30 or 45 ml/min/1.73m2 at Months 12 and 24, Incidence of treated biopsy-proven rejection (tBPAR), Rejection treatment and type of rejection treatment, The evolution of renal function (eGFR and creatinine clearance) over time by slope analysis, The incidence of adverse events, serious adverse events and adverse reactions, The incidence of clinically relevant infections, post transplantation diabetes mellitus, malignancies and cardiovascular events, Presence of frailty at 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 0, 12 and 24 months and changes from baseline, Development of donor-specific anti-HLA antibodies (DSA), Difference in illness perception at 0, 12 and 24 months and changes from baseline, Difference in BAASIS at 12 and 24 months, Difference in symptoms (DSI + MTSOSD-59) at 0, 12 nad 24

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Countries

Belgium, Netherlands

Outcome results

None listed