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

NCT ID: NCT02314312

Last Updated: 2014-12-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2015-06-30

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

Conditions

Transplantation of Kidney; Expanded Criteria Donor; ECD

Keywords

Kidney transplantation; ECD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A: investigation arm

De novo kidney transplantation form ECD/AKI donor with Everolimus + low dose cyclosporinA + prednisolone as immunosuppressive regimen

Group Type: EXPERIMENTAL

Everolimus + low dose cyclosporin A + prednisolone

Intervention Type: DRUG

B: control arm

De novo kidney transplantation form ECD/AKI donor with standard immunosuppressive regimen

Group Type: OTHER

Standard immunosupressive regimen

Intervention Type: DRUG

Interventions

Everolimus + low dose cyclosporin A + prednisolone

Intervention Type: DRUG

Standard immunosupressive regimen

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mahidol University

OTHER

Sponsor Role: lead

Responsible Party

CHALERMPON NA PETVICHARN

Ramathibodi Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Surasak Kantachuvesiri, M.D., PH.D

Role: PRINCIPAL_INVESTIGATOR

Ramathibodi Hospital, Mahidol University

Other Identifiers

CRAD001ATH01T

Identifier Type: -

Identifier Source: org_study_id