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

Mahidol University

Status and phase

Unknown

Phase 3

Conditions

Transplantation of Kidney

ECD

Expanded Criteria Donor

Treatments

Drug: Everolimus + low dose cyclosporin A + prednisolone

Drug: Standard immunosupressive regimen

Study type

Interventional

Funder types

Other

Identifiers

NCT02314312

CRAD001ATH01T

Details and patient eligibility

About

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

Full 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

Enrollment

48 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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.