Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
Study NCT ID:
NCT02314312
Status:
UNKNOWN
Last Update Posted:
2014-12-11
First Post:
2014-12-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Everolimus in de Novo Kidney Transplant Recipients of ECD or AKI Donors
Sponsor:
Mahidol University
Organization:
Study Overview
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:
UNKNOWN
Status Verified Date:
2014-12
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
* 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: