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

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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02314312

Enrollment

Registered

2014-12-11

Start date

2012-01-31

Completion date

2015-06-30

Last updated

2014-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ECD, Expanded Criteria Donor, Transplantation of Kidney

Keywords

Kidney transplantation, ECD

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

Interventions

DRUGEverolimus + low dose cyclosporin A + prednisolone

DRUGStandard immunosupressive regimen

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
eGFR (CKD-EPI)	12 months post kidney transplantation

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026