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Completed Phase 4 Interventional Results available

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

ClinicalTrials.gov ID: NCT02723591

Public ClinicalTrials.gov record NCT02723591. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 3, 2026, 5:07 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Astagraf XL® to Understand the Impact of Immunosuppression on De Novo DSA Development and Chronic Immune Activation in Kidney Transplantation

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT02723591
Recruitment status
Completed
Study type
Interventional
Phase
Phase 4
Enrollment
599 participants

Conditions and interventions

Eligibility (public fields only)

Age range
16 Years to 70 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 8, 2016
Primary completion
Jun 13, 2019
Completion
Jun 13, 2019
Last update posted
Dec 17, 2024

2016 – 2019

United States locations

U.S. sites
30
U.S. states
20
U.S. cities
27
Facility City State ZIP Site status
Site US10006 Birmingham Alabama 35294
Site US10025 Scottsdale Arizona 85259
Site US10031 Los Angeles California 90033
Site US10005 Sacramento California 95817
Site US10016 San Francisco California 94115
Site US10024 Aurora Colorado 80045
Site US10003 New Haven Connecticut 06510
Site US10014 Washington D.C. District of Columbia 20007
Site US10030 Jacksonville Florida 32224
Site US10020 Chicago Illinois 60605
Site US10010 Chicago Illinois 60611
Site US10001 Baltimore Maryland 21201
Site US10007 Boston Massachusetts 02114
Site US10013 Ann Arbor Michigan 48109
Site US10032 Detroit Michigan 48202
Site US10029 Minneapolis Minnesota 55455
Site US10027 Rochester Minnesota 55905
Site US10019 Livingston New Jersey 07039
Site US10004 Buffalo New York 14215
Site US10037 New York New York 10032
Site US10022 New York New York 10065
Site US10028 New York New York 10467
Site US10021 Syracuse New York 13210
Site US10026 Portland Oregon 97210
Site US10002 Charleston South Carolina 29425
Site US10036 Houston Texas 77030
Site US10018 Salt Lake City Utah 84112
Site US10012 Charlottesville Virginia 22903
Site US10008 Falls Church Virginia 22042
Site US10023 Madison Wisconsin 53792

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02723591, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Dec 17, 2024 · Synced Sep 3, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT02723591 live on ClinicalTrials.gov.

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