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NCT03707262 · ClinicalTrials.gov registry record · Phase 1

Study of Combined Kidney and Blood Stem Cell Transplant From a Brother or Sister Donor

A Phase 1 study of Kidney Transplant and Tolerance, sponsored by Jeffrey Veale, MD.

Recruiting
Registry status
Phase 1
Development phase
15
Enrollment target
1
Study location

NCT03707262 is a Phase 1 study of Kidney Transplant and Tolerance that is actively recruiting participants, run by Jeffrey Veale, MD. The registered enrollment target is 15 participants, below the 1,898-participant average among 30 other Kidney Transplant trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03707262, a Phase 1 study of Kidney Transplant and Tolerance, is actively recruiting participants, sponsored by Jeffrey Veale, MD.

RECRUITING
Registry status
Phase 1
Development phase
15 participants
Enrollment target
1
Study location

Study Summary

The purpose of this study is to find out if an investigational treatment will allow kidney transplant recipients to better accept their new kidney and stop immunosuppressive medicines. This study is for kidney transplant recipients who receive a kidney from a sibling donor. The investigational treatment is started after kidney transplant. It begins with a regimen of a drug called rabbit anti-thymocyte globulin (rATG) combined with radiation therapy (known as total lymphoid irradiation, or TLI) to the lymph nodes and spleen. This is followed by an infusion of blood stem cells, which will be donated by the same sibling who donated their kidney. Researchers think that this treatment allows immune cells from the donor and recipient to live side by side, a condition referred to as "mixed chimerism." Mixed chimerism may help create a state of "tolerance" in kidney transplant recipients in which all immunosuppressive medications can be stopped without rejection of the transplanted kidney. This study will test whether (1) the investigational treatment will allow patients to stop immunosuppressive medications after their kidney transplant and (2) if the treatment impacts the rate of kidney rejection and the side effects of immunosuppressive medications.

Interventions

  • BIOLOGICAL Donor CD34+ and CD3+ cells

Study Locations (1)

California

  • University of California, Los Angeles - Los Angeles

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2019-11-06
Est. Completion 2026-02
Phase Phase 1

Sponsor

Jeffrey Veale, MD

1 total trials

What the Registry Record Tells You About NCT03707262

The ClinicalTrials.gov registry entry for NCT03707262 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,898-participant average among 30 other Kidney Transplant trials with a reported enrollment target (99% lower). The listed sponsor is Jeffrey Veale, MD, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Kidney Transplant appearing as the primary indexed condition, and to 1 intervention - of which Donor CD34+ and CD3+ cells is the first listed.

NCT03707262 reports 1 study location spanning 1 distinct geographic area - top geographies include California.

Frequently Asked Questions

What is clinical trial NCT03707262 about?

NCT03707262 is a clinical study titled "Study of Combined Kidney and Blood Stem Cell Transplant From a Brother or Sister Donor". The purpose of this study is to find out if an investigational treatment will allow kidney transplant recipients to better accept their new kidney and stop immunosuppressive medicines. This study is for kidney transplant recipients who receive a kidney from a sibling donor. The investigational trea...

What is the current status of trial NCT03707262?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2019-11-06. Estimated completion is 2026-02.

What conditions does trial NCT03707262 study?

This clinical trial studies the following conditions: Kidney Transplant, Tolerance, Renal Transplant Rejection.

What interventions are being tested in trial NCT03707262?

The interventions under investigation include: Donor CD34+ and CD3+ cells (BIOLOGICAL).

Who is sponsoring clinical trial NCT03707262?

This trial is sponsored by Jeffrey Veale, MD, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03707262 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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