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NCT05004493 · ClinicalTrials.gov registry record

Biorepository and Registry for Plasma Exchange Patients

A clinical trial of Antibody-mediated Rejection and CIDP, sponsored by Charles M Knudson.

Recruiting
Registry status
200
Enrollment target
1
Study location

NCT05004493 is a study of Antibody-mediated Rejection and CIDP that is actively recruiting participants, run by Charles M Knudson. The registered enrollment target is 200 participants, above the 132-participant average among 5 other Antibody-mediated Rejection trials with a reported enrollment target (52% higher). The trial reports 1 study location across 1 state.

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The verdict

NCT05004493, a study of Antibody-mediated Rejection and CIDP, is actively recruiting participants, sponsored by Charles M Knudson.

RECRUITING
Registry status
200 participants
Enrollment target
1
Study location

Study Summary

Patients who have immune mediated diseases commonly undergo plasma exchange (PLEX) procedures to remove pathological substances, typically believed to be antibodies. At our facility about 400 of these procedures are performed annually on 40-60 different patients. These procedures are considered within the standard of care for these patients and are covered by insurance. This study will not influence the treatment plan for subjects who participate in this study. The goal of the study is to collect and cryopreserve blood biospecimens (plasma, serum, PBMCs) for current and future studies. Any patient undergoing plasma exchange procedures will be eligible for the study. Patients or the legally authorized representative (LAR) will be consented for the study as soon as feasible after the are referred to DeGowin for plasma exchange. The immediate objective of the study is to examine antibody levels (IgG/IgM) and BAFF levels in the blood of these patients over the course of the plasma exchange treatments. Specimens and clinical data will be collected such that other immune factors that may regulate B cell survival, proliferation and antibody secretion can be studied. Another goal of the study is to isolate and cryopreserve PBMCs at different points during the patient's treatment. This would allow the study of immune cells that may mediate these diseases. The study will also follow pathological antibodies over time in these patients so biospecimens can be obtained even after the completion of their course of plasma exchange treatments. The collection of biospecimens and clinical information from these subjects will help us understand the impact of plasma exchange on both normal and pathological immune factors in a variety of patients undergoing these procedures.

Study Locations (1)

Iowa

  • DeGowin blood Center - Iowa City

Trial Details

FieldValue
Enrollment Target 200 participants
Start Date 2021-07-28
Est. Completion 2040-12-31

Sponsor

Charles M Knudson

1 total trials

What the Registry Record Tells You About NCT05004493

The ClinicalTrials.gov registry entry for NCT05004493 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 132-participant average among 5 other Antibody-mediated Rejection trials with a reported enrollment target (52% higher). The listed sponsor is Charles M Knudson, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Antibody-mediated Rejection appearing as the primary indexed condition, and to 0 interventions.

NCT05004493 reports 1 study location spanning 1 distinct geographic area - top geographies include Iowa.

Frequently Asked Questions

What is clinical trial NCT05004493 about?

NCT05004493 is a clinical study titled "Biorepository and Registry for Plasma Exchange Patients". Patients who have immune mediated diseases commonly undergo plasma exchange (PLEX) procedures to remove pathological substances, typically believed to be antibodies. At our facility about 400 of these procedures are performed annually on 40-60 different patients. These procedures are considered with...

What is the current status of trial NCT05004493?

This trial is currently recruiting. The enrollment target is 200 participants. The study started on 2021-07-28. Estimated completion is 2040-12-31.

What conditions does trial NCT05004493 study?

This clinical trial studies the following conditions: Antibody-mediated Rejection, CIDP, NMO Spectrum Disorder, TTP.

Who is sponsoring clinical trial NCT05004493?

This trial is sponsored by Charles M Knudson, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05004493 being conducted?

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

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