Clinical trial NCT02314312: Efficacy and Safety of Everolimus in de Novo Kidney Transplant Recipients of ECD or AKI Donors
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Transplantation of Kidney
Expanded Criteria Donor
ECD
Keywords: Kidney transplantation
ECD
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2014-12-11
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: eGFR (CKD-EPI)
timeFrame: 12 months post kidney transplantation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ramathibodi Hospital, Mahidol University
name: Surasak Kantachuvesiri, M.D., PH.D
role: PRINCIPAL_INVESTIGATOR
References: