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

ECD Clinical Trial

Official title:
A 12 Month, Single-center, Open-label, Randomized-controlled Trial to Investigate Efficacy, Safety and Tolerability of Everolimus in Combination With Cyclosporine A and Corticosteroid in de Novo Transplant Recipients of Expanded Criteria Donor Kidneys or Acute Kidney Injury

Status Active, not recruiting

Clinical Trial Summary

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

Clinical Trial Description

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02314312
Study type	Interventional
Source	Mahidol University
Contact
Status	Active, not recruiting
Phase	Phase 3
Start date	January 2012
Completion date	June 2015

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