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

NCT02314312 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2014-12-11

No results posted yet for this study

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

Conditions

  • Transplantation of Kidney
  • Expanded Criteria Donor
  • ECD

Interventions

DRUG

Everolimus + low dose cyclosporin A + prednisolone

DRUG

Standard immunosupressive regimen

Sponsors & Collaborators

  • Mahidol University

    lead OTHER

Principal Investigators

  • Surasak Kantachuvesiri, M.D., PH.D · Ramathibodi Hospital, Mahidol University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2015-06-30
Completion
2015-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02314312 on ClinicalTrials.gov