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Extended Release Tacrolimus vs. Twice-Daily Tacrolimus

NCT03289650 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2023-04-10

Study results available
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Summary

The overall aim of the study is to prospectively investigate the impact of two maintenance calcineurin inhibitor immunosuppressive regimens: once-daily extended release tacrolimus and twice-daily tacrolimus on subpopulations of T and B cells and alloreactive T cells as well as on renal allograft function.

Conditions

Interventions

DRUG

Tacrolimus

immunosuppressive agent tacrolimus, given twice-daily

DRUG

Tacrolimus Extended Release Oral Tablet [Envarsus]

immunosuppressive agent extended-release tacrolimus, given once daily

Sponsors & Collaborators

  • Lorenzo Gallon

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-09-05
Primary Completion
2021-02-23
Completion
2021-02-23
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT03289650 on ClinicalTrials.gov