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AGe-adapted Benefits of Envarsus Versus Twice-daily Tacrolimus ImmunosuppressioN druGs After Kidney Transplantation

NCT03005236 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2016-12-29

No results posted yet for this study

Summary

The proportion of elderly patients with end-stage kidney disease undergoing renal replacement therapy (RRT) is steadily increasing. Although kidney transplantation remains the optimal RRT of choice, it is clear that older adults have a differential risk versus benefit profile after kidney transplantation compared to younger adults. No age-adapted immunosuppression for older adults has been shown to improve kidney allograft outcomes but recent sub-analyses of clinical trial data has hinted at improved outcomes for older kidney transplant patients receiving Envarsus versus standard twice-daily tacrolimus formulations. This feasibility study will investigate this effect to see whether a full scale randomised controlled trial is warranted and to provide information regarding study feasibility.

Conditions

  • Kidney Transplant Failure and Rejection

Interventions

DRUG

ENVARSUS

Envarsus is a once-a-day oral formulation of tacrolimus.

DRUG

Standard twice daily tacrolimus

Standard tacrolimus will include twice-daily formulations that are currently available.

Sponsors & Collaborators

  • University Hospital Birmingham NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Adnan Sharif, MD · Consultant Nephrologist

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-30
Primary Completion
2019-04-30
Completion
2019-10-31

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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 NCT03005236 on ClinicalTrials.gov