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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 Oct 18, 2026, 7:37 PM 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

Brief summary

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

A randomized controlled study to evaluate the safety, efficacy, and overall benefit of FCR001 cell therapy in de novo living donor renal transplantation.

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

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 25, 2019 (Actual)
Primary completion
Feb 16, 2023 (Actual)
Completion
Feb 16, 2023 (Actual)
Last update posted
Mar 3, 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 3, 2023 · Synced Oct 18, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03995901 live on ClinicalTrials.gov.

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