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NCT02244801 · ClinicalTrials.gov registry record · Phase 1

Donor-Alloantigen-Reactive Regulatory T Cell (darTreg) Therapy in Renal Transplantation (The ONE Study )

A Phase 1 study, sponsored by University of California, San Francisco.

Completed
Registry status
Phase 1
Development phase
6
Enrollment target

NCT02244801: Completed Phase 1 study, sponsored by University of California, San Francisco.

NCT02244801 is a Phase 1 study that has completed, run by University of California, San Francisco. The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02244801, a Phase 1 study, has completed, sponsored by University of California, San Francisco.

COMPLETED
Registry status
Phase 1
Development phase
6 participants
Enrollment target

Study Summary

This Phase I pilot study will evaluate the safety, and tolerability of darTreg infusion for adult, de novo, living donor renal transplant recipients.

Primary Outcome

Explore the immunomodulatory potential, safety and tolerability of a single infusion of darTregs as adjunct immunosuppressive treatment through the incidence of biopsy-confirmed acute rejection (BCAR) within 60 weeks following renal transplantation.

Interventions

  • DRUG darTreg infusion

Trial Details

FieldValue
Enrollment Target 6 participants
Start Date 2015-04
Est. Completion 2018-08-28
Phase Phase 1

What the finished NCT02244801 record still lists

NCT02244801 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).

The record links to 0 conditions, and to 1 intervention - of which darTreg infusion is the first listed.

NCT02244801 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02244801 about?

NCT02244801 is a clinical study titled "Donor-Alloantigen-Reactive Regulatory T Cell (darTreg) Therapy in Renal Transplantation (The ONE Study )". This Phase I pilot study will evaluate the safety, and tolerability of darTreg infusion for adult, de novo, living donor renal transplant recipients.

What is the current status of trial NCT02244801?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2015-04. Estimated completion is 2018-08-28.

What interventions are being tested in trial NCT02244801?

The interventions under investigation include: darTreg infusion (DRUG).

Who is sponsoring clinical trial NCT02244801?

This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02244801's enrollment target sits among peer trials

6 1974th of 2000 higher than 12 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02244801, the US trial registry maintained by the National Library of Medicine. NCT02244801 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.