Recruiting

Observational Study

Sponsor:

Charles M Knudson

Code:

NCT05004493

Conditions

Antibody-mediated Rejection

NMO Spectrum Disorder

TTP

CIDP

Eligibility Criteria

Sex: All

Age: 12 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief 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.

Conditions

Antibody-mediated Rejection

NMO Spectrum Disorder

TTP

CIDP

Study ID

NCT05004493

Start date

Jul 28, 2021

Status verified date

May, 2025

Completion date

Dec 31, 2040

Anticipated

Primary completion date

Dec 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 70+

Healthy Volunteers: Not accepted

Pts undergoing plasma exchange therapy are eligible to be in this protocol

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

Plasma arm

Patients receiving plasma as one of the main replacement fluids

No Plasma

Patients receiving saline and/or 5% albumin as the replacement fluid.

Primary outcome measure

  • IgG and IgM antibody levels [ Time Frame: Levels over the course of treatment will be compared. Typically 1-2 weeks. ]

Central Contacts and Locations

Central contacts

Charles Knudson, MD, PHD

+1 319 467-5129c-knudson@uiowa.edu

Locations

DeGowin blood Center

Recruiting

Iowa City, Iowa, United States, 52242

More Information

Sponsor

Charles M Knudson

Last update posted

May 20, 2025

Last verified

May, 2025

Keywords

  • plasma exchange
  • plasmapheresis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Charles M Knudson on 2025-05-20.