Efficacy and Safety of Everolimus in de Novo Kidney Transplant Recipients of ECD or AKI Donors

Mahidol University48 enrolled

Overview

Single center, open-label randomized-control trial Population: de novo 48 kidney transplant recipients (age 18-75 years) from ECD/AKI donors Compare: everolimus with low dose CNI and prednisolone versus standard immunosuppressive regimen Objective: To evaluate efficacy of everolimus with low dose CNI in de novo kidney transplant recipients of ECD/AKI donors Primary endpoint: Mean eGFR (CKD-EPI) at 12 months post-transplantation

Secondary Endpoints: * To assess renal function by means of eGFR (Cockcrault and Gault formula), at -Month 6 and 12 post-transplantation * To assess incidence of the individual composite endpoints including BPAR, graft loss and death at Month 6 and 12 post-transplantation * To assess the incidence and duration of renal replacement therapy * To assess the incidence of chronic allograft nephropathy (IF/TA) at Month 12 * To assess renal function by means of serum creatinine at Month 6 and 12 post-transplantation * To compare the overall safety and tolerability (incidence of AEs and SAEs, infections, discontinuations due to AEs, lab abnormalities, wound and surgical complications) at Month 6 and 12 post-transplantation Definition of ECD * Brain-dead donor \> 60 years old or * Donor age \> 50 years old with two of the following criteria; * History of HT * Terminal SCr. ≥ 1.5 mg/dL * Death from cerebrovascular accident Definition of AKI donor * Brain-dead donor with an increase of SCr. ≥ 0.3 mg/dL from baseline

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Transplantation of Kidney Expanded Criteria Donor ECD

Interventions

Everolimus + low dose cyclosporin A + prednisoloneDRUG

Standard immunosupressive regimenDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age 18-75 years * Recipients of first DDKT from ECD or AKI donors * Patient willing to participate in the study Exclusion Criteria: * Multi-organ recipients * Organ donation after Cardiac Death (DCD). * PRA \> 20 % or with historical peak PRA \> 50% * Patients who lost first graft due to immunological reason within the first year post-transplantation. * ABO incompatible transplants or positive cross-match * Patients with chronic inflammatory bowel disease. * Severe allergy requiring acute treatment, or any known hypersensitivity to everolimus, thymoglobulin * Thrombocytopenia (platelet \< 75,000/mm3), ANC \< 1,500 /mm3 or leucopenia (leucocytes \< 2,500/mm3), or Hb \< 6 g/dL * Chronic active HCV, HIV, or HBsAg positive * History of malignancy during the last five years, except squamous or basal cell carcinoma of the skin. * Ongoing infection requiring treatment with a systemic antibiotic. * Patient with severe hypercholesterolemia (\> 300 mg/dL) or hypertriglyceridemia (\> 600 mg/dL) that cannot be controlled * Evidence of severe liver disease. * Severe restrictive or obstructive pulmonary disorders. * Pregnant or nursing (lactating) women. * Patient who refuse to participate into the study or would like to withdraw from the study.

Outcomes

Primary Outcomes

eGFR (CKD-EPI)

Time frame: 12 months post kidney transplantation

Data from ClinicalTrials.gov

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