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Not listed Phase 1Phase 2 Interventional

Evaluating Safety and Efficacy of TOL101 Induction Versus Anti-Thymocyte Globulin to Prevent Kidney Transplant Rejection

ClinicalTrials.gov ID: NCT01154387

Public ClinicalTrials.gov record NCT01154387. 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 Jul 22, 2026, 12:37 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 Two Part, Phase 1/2, Safety, PK and PD Study of TOL101, an Anti-TCR Monoclonal Antibody for Prophylaxis of Acute Organ Rejection in Patients Receiving Renal Transplantation

Study identification

NCT ID
NCT01154387
Recruitment status
Not listed
Study type
Interventional
Phase
Phase 1, Phase 2
Lead sponsor
Tolera Therapeutics, Inc
Industry
Enrollment
85 participants

Conditions and interventions

Interventions

  • Anti-Thymocyte Globulin Drug
  • TOL101 Drug
  • Steroids Drug
  • Tacrolimus Drug
  • Mycophenolate mofetil (MMF) Drug

Drug

Eligibility (public fields only)

Age range
18 Years to 60 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
Jun 30, 2010
Primary completion
May 31, 2013
Completion
May 31, 2013
Last update posted
Jun 10, 2013

2010 – 2013

United States locations

U.S. sites
12
U.S. states
10
U.S. cities
12
Facility City State ZIP Site status
University of Colorado Denver Aurora Colorado 80045
University of Kentucky Lexington Kentucky 40536
University of Michigan Ann Arbor Michigan 48109
St Barnabas Medical Center Livingston New Jersey 07039
Buffalo General Hospital Buffalo New York 14203
Montefiore Medical Center The Bronx New York 10467
Cleveland Clinic Foundation Cleveland Ohio 44195
Medical University of South Carolina Charleston South Carolina 29425
Baylor University Medical Center Dallas Texas 75246
Baylor All Saints Fort Worth Texas 76104
University of Utah Salt Lake City Utah 84132
University of Virginia Health System Charlottesville Virginia 22908

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 NCT01154387, 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 Jun 10, 2013 · Synced Jul 22, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01154387 live on ClinicalTrials.gov.

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