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ACTIVE NOT RECRUITING

Highly Suppressive Treg in Delayed and Slow Graft Function After Kidney Transplantation

NCT04414111 · View on ClinicalTrials.gov ↗

Study Summary

Delayed/slow graft function is the most common complication after kidney transplantation with an incidence over 20% and is the result of ischemia-reperfusion injury. The increased use of marginal kidney grafts to palliate the organ shortage is leading to a continued rise in the incidence of delayed/slow graft function. Delayed/slow graft function, however, is associated with an increased risk of acute rejection and graft failure. There are currently no clinically accepted biomarkers and no specific treatments for delayed/slow graft function. Regulatory T cells are protective in ischemia-reperfusion injury and rejection by suppressing pathologic immune responses. We hypothesize that the pre-transplant measurement of highly suppressive regulatory T cell is an accurate biomarker for delayed/slow graft function and its immunologic consequences. Ultimately, marginal kidney graft allocation could be directed to regulatory T cell-robust recipients and regulatory T cell-directed therapies could decrease marginal kidney graft discards without increasing delayed/slow graft function or impacting outcomes.

Interventions

  • DIAGNOSTIC_TEST Highly suppressive Treg measurement

Study Locations (2)

California

  • Loma Linda University Health Transplantation Institute — San Bernardino

Missouri

  • Saint Louis University — St Louis

Trial Details

FieldValue
Enrollment Target 180 participants
Start Date 2020-12-07
Est. Completion 2027-07-31

Sponsor

St. Louis University

35 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04414111

The ClinicalTrials.gov registry entry for NCT04414111 describes a study currently listed as active not recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 180 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is St. Louis University, which has 35 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Kidney Transplant; Complications appearing as the primary indexed condition, and to 1 intervention — of which Highly suppressive Treg measurement is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04414111 reports 2 study locations spanning 2 distinct geographic areas — top geographies include California, Missouri. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04414111 about?

NCT04414111 is a clinical study titled "Highly Suppressive Treg in Delayed and Slow Graft Function After Kidney Transplantation". Delayed/slow graft function is the most common complication after kidney transplantation with an incidence over 20% and is the result of ischemia-reperfusion injury. The increased use of marginal kidney grafts to palliate the organ shortage is leading to a continued rise in the incidence of delayed/...

What is the current status of trial NCT04414111?

This trial is currently active not recruiting. The enrollment target is 180 participants. The study started on 2020-12-07. Estimated completion is 2027-07-31.

What conditions does trial NCT04414111 study?

This clinical trial studies the following conditions: Kidney Transplant; Complications, DGF. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04414111?

The interventions under investigation include: Highly suppressive Treg measurement (DIAGNOSTIC_TEST). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04414111?

This trial is sponsored by St. Louis University, which has 35 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04414111 being conducted?

This trial has 2 study locations across California, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial