Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
NCT ID:
NCT02314312
Brief 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
Detailed 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:
NCT02314312
Study Brief:
Protocol Section:
NCT02314312