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RCT Comparing Immunosuppressive Regimens in Elderly Renal Transplant Recipients

NCT03797196 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 374

Last updated 2023-05-10

No results posted yet for this study

Summary

Open label, randomized, multicenter, intervention trial comparing standard immunosuppression with tacrolimus and mycophenolate mofetil with a low exposure tacrolimus regimen in combination with everolimus.

The primary objective is to test the hypothesis that an age-adapted immunosuppressive regimen targeted at reduced immunosuppression with low calcineurin inhibitor (tacrolimus) exposure in combination with everolimus will result in improved outcome in elderly recipients of A: Kidneys from older deceased donors (\>64 years) and B: Kidneys from living donors (all ages) and younger deceased donors (\<65 years).

Conditions

  • Renal Transplant Recipients
  • Elderly Patients
  • Immunosuppression

Interventions

DRUG

low dose tacrolimus in combination with everolimus

a low exposure Tacrolimus once-daily (Envarsus®) regimen in combination with Everolimus will be evaluated in elderly transplant recipients

DRUG

standard dose tacrolimus with mycophenolate mofetil

A standard Tacrolimus once-daily (Envarsus) regimen in combination with Everolimus will be evaluated in elderly transplant recipients

Sponsors & Collaborators

  • Radboud University Medical Center

    collaborator OTHER

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    collaborator OTHER

  • Amsterdam UMC, location VUmc

    collaborator OTHER

  • UMC Utrecht

    collaborator OTHER

  • Leiden University Medical Center

    collaborator OTHER

  • Erasmus Medical Center

    collaborator OTHER

  • Universitaire Ziekenhuizen KU Leuven

    collaborator OTHER

  • University Medical Center Groningen

    lead OTHER

Principal Investigators

  • Dennis Hesselink, MD, PhD · EMC

  • Frederike Bemelman, Md, PhD · AIDS Malignancy Consortium

  • Stefan Berger, Md, PhD · UMCG

  • Jan-Stephan Sanders, MD, PhD · UMCG

  • Azam Nurmohamed, Md, PhD · VUMC

  • Aiko De Vries, MD, PhD · LUMC

  • Luuk Hilbrands, Md, PhD · Radboud MC

  • Arjan Van Zuilen, MD, PhD · UMCU

  • Dirk Kuypers, MD, PhD · Leuven MC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-29
Primary Completion
2025-06-30
Completion
2026-12-31

Countries

  • Belgium
  • Netherlands

Study Locations

More Related Trials

Entities

Companies

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 NCT03797196 on ClinicalTrials.gov