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Efficacy and Safety of a Reduced Immunosuppression vs. Standard Triple Therapy in Senior Renal Transplant Recipients

NCT02453867 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2017-08-09

No results posted yet for this study

Summary

Study purpose To establish efficacy and safety of a reduced immunosuppressive therapy with tacrolimus once daily for senior (\>65 years of age) renal transplant recipients

Conditions

  • Immunosuppression After Renal Transplantation

Interventions

OTHER

Reduced immunosuppression

Stop steroids at month 3 Stop mycophenolate at month 6 continue tacrolimus once daily (Advagraf, trough levels \> 5ng/ml) Stop mycophenolate at month 6

DRUG

Tacrolimus

Tacrolimus is used in both the acitve comparator arm and the interventional arm

DRUG

mycophenolate

Mycophenolate is used in the acitve comparator arm for the whole study period; Mycophenolate is stopped at month 6 after Transplantation (month 3 of the study) in the experimental arm

DRUG

Steroids

Steroids are used continually in the active comparator arm and are stopped at the beginning of the study (month 3 after Transplantation) as an Intervention in the experimental arm

Sponsors & Collaborators

  • Charite University, Berlin, Germany

    collaborator OTHER

  • European Renal Association - European Dialysis and Transplant Association

    collaborator OTHER

  • European Kidney Transplant Association (EKITA)

    collaborator OTHER

  • DESCARTES Working Group On Transplantation

    collaborator OTHER

  • Klemens Budde

    lead OTHER

Principal Investigators

  • Klemens Budde, MD · Charite Universitaetsmedizin Berlin

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-31
Primary Completion
2018-07-31
Completion
2019-07-31

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Drugs

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 NCT02453867 on ClinicalTrials.gov