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To Compare the Effects of Immediate-release Tacrolimus and Astagraf XL on Donor-Specific Antibody (DSA) Formation and the Development of Immune Activation (IA) in de Novo Kidney Transplant Recipients

NCT02723591 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 599

Last updated 2024-12-18

Study results available
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Summary

This study compared the incidence of a two-part composite endpoint consisting of de novo donor specific antibody (DSA) formation or a designation of immune activation (IA) on peripheral blood molecular profiling in participants maintained on twice daily, immediate-release tacrolimus versus those maintained on Astagraf XL in the first year post-transplant.

Conditions

  • Kidney Transplantation

Interventions

DRUG

Tacrolimus

Oral Capsule

DRUG

Tacrolimus immediate release

Oral Capsule

Sponsors & Collaborators

  • Astellas Pharma Global Development, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Astellas Medical Affairs, Americas

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-09
Primary Completion
2019-06-14
Completion
2019-06-14

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT02723591 on ClinicalTrials.gov