Verslagen

Samenvatting van de aanvraag

Samenvatting
Dit item is dichtgeklapt
Dit item is opengeklapt

PROBLEM DEFINITION

In elderly recipients kidney transplantation is characterized by increased patient mortality and worse kidney function while death censored graft loss is a relatively rare event. This calls for an adapted approach to immunosuppression (IS).

 

OBJECTIVES

To compare standard IS with a regimen aiming for reduced immunopsuppression and preservation of graft function in elderly transplant recipients.

 

STUDY DESIGN

Randomized controlled trial

 

PATIENT POPULATION

Recipients aged 65 and above receiving a kidney allograft from a deceased donor aged 65 and above (part A) or from either a deceased donor below 65 years or a living donor of any age (part B)

 

INVESTIGATIONAL PRODUCT & COMPARATOR

Standard IS with prednisolon, tacrolimus and mycophenolate mofetil compared with a regimen consisting of prednisolon, very low dose tacrolimus and everolimus.

 

OUTCOME VARIABLE

Primary: successful transplantation at 2 years after transplantation defined as: absence of graft or patient loss in the presence of an eGFR above 30 ml/min (part A) or 45 ml/min (part B).

 

OUTCOME ASSESSMENT

Kidney function will be assessed as eGFR.

 

ANALYSIS

Intent-to-treat analysis

 

SAMPLE SIZE CALCULATION

To detect a difference of 20% in the endpoint successful transplantation with a power of 80% 192 patients are needed for part A and 180 for part B.

 

ECONOMIC EVALUATION

Better renal function is associated with less complications and improved quality of life. These aspects will be integrated in a lifetime economic decision model.

 

Naar boven
Direct naar: InhoudDirect naar: NavigatieDirect naar: Onderkant website