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Terminated Phase 3 Interventional

A Safety and Efficacy Study of FCR001 vs Standard of Care in de Novo Living Donor Kidney Transplantation

ClinicalTrials.gov ID: NCT03995901

Public ClinicalTrials.gov record NCT03995901. 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 Jun 26, 2026, 10:53 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

A Randomized, Controlled, Multi-center, Safety and Efficacy Study of FCR001 Cell-based Therapy Relative to a Tacrolimus and Mycophenolate-based Regimen in de Novo Living Donor Renal Transplant Recipients, and Safety in FCR001 Donors

Study identification

NCT ID
NCT03995901
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 3
Lead sponsor
Talaris Therapeutics Inc.
Industry
Enrollment
15 participants

Conditions and interventions

Interventions

  • FCR001 Biological

Biological

Eligibility (public fields only)

Age range
18 Years and older
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
Oct 24, 2019
Primary completion
Feb 15, 2023
Completion
Feb 15, 2023
Last update posted
Mar 2, 2023

2019 – 2023

United States locations

U.S. sites
18
U.S. states
15
U.S. cities
17
Facility City State ZIP Site status
Mayo Clinic Phoenix Arizona 85054
Scripps Clinic La Jolla California 92037
University of California, San Francisco San Francisco California 94143
Georgetown University Hospital Washington D.C. District of Columbia 20007
Mayo Clinic Jacksonville Florida 32224
Northwestern Memorial Hospital Chicago Illinois 60611
The University of Michigan Hospitals & Health System Ann Arbor Michigan 48109
University of Minnesota Medical Center Minneapolis Minnesota 55455
Mayo Clinic Rochester Minnesota 55905
University of Nebraska Medical Center Omaha Nebraska 68198
New York-Presbyterian/Weill Cornell New York New York 10065
Duke University Medical Center Durham North Carolina 27710
The Ohio State University Wexner Medical Center Columbus Ohio 43210
Oregon Health & Science University Portland Oregon 97239
Hospital of the University of Pennsylvania Philadelphia Pennsylvania 19104
Baylor University Medical Center Dallas Texas 75246
UT Southwestern Medical Center Dallas Texas 75390
Virginia Commonwealth University Richmond Virginia 23298

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 NCT03995901, 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 Mar 2, 2023 · Synced Jun 26, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03995901 live on ClinicalTrials.gov.

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