Biorepository and Registry for Plasma Exchange Patients

Antibody-mediated Rejection Clinical Trial

Official title:

Assessment of Changes in Normal and Pathological Immune Factors in Patients Undergoing Plasma Exchange

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05004493
• Other study ID #: 202104462
• Status: Recruiting
• Start date: July 28, 2021
• Est. completion date: December 31, 2040

Study information

• Verified date: November 2023
• Source: University of Iowa
• Contact: Charles Knudson, MD, PHD
• Phone: +1 319 467-5129
• Email: c-knudson[@]uiowa.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2040
• Est. primary completion date: December 31, 2030
• Gender: All
• Age group: 12 Years to 99 Years
• Eligibility: Pts undergoing plasma exchange therapy are eligible to be in this protocol

Related Conditions & MeSH terms

• Antibody-mediated Rejection
• CIDP
• Neuromyelitis Optica
• NMO Spectrum Disorder
• TTP

Locations

Country	Name	City	State
United States	DeGowin blood Center	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Charles M Knudson

Country where clinical trial is conducted

United States, 

References & Publications (4)

Mockel T, Basta F, Weinmann-Menke J, Schwarting A. B cell activating factor (BAFF): Structure, functions, autoimmunity and clinical implications in Systemic Lupus Erythematosus (SLE). Autoimmun Rev. 2021 Feb;20(2):102736. doi: 10.1016/j.autrev.2020.102736. Epub 2020 Dec 14. — View Citation

Reeves HM, Winters JL. The mechanisms of action of plasma exchange. Br J Haematol. 2014 Feb;164(3):342-51. doi: 10.1111/bjh.12629. Epub 2013 Oct 30. — View Citation

Schiemann B, Gommerman JL, Vora K, Cachero TG, Shulga-Morskaya S, Dobles M, Frew E, Scott ML. An essential role for BAFF in the normal development of B cells through a BCMA-independent pathway. Science. 2001 Sep 14;293(5537):2111-4. doi: 10.1126/science.1061964. Epub 2001 Aug 16. — View Citation

Winters JL. Plasma exchange: concepts, mechanisms, and an overview of the American Society for Apheresis guidelines. Hematology Am Soc Hematol Educ Program. 2012;2012:7-12. doi: 10.1182/asheducation-2012.1.7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IgG and IgM antibody levels	The effect of replacement fluids on IgG and IgM antibody levels will be examined.	Levels over the course of treatment will be compared. Typically 1-2 weeks.