Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05004493
Other study ID # 202104462
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
Gender All
Age group 12 Years to 99 Years
Eligibility Pts undergoing plasma exchange therapy are eligible to be in this protocol

Study Design


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.
See also
  Status Clinical Trial Phase
Completed NCT02533596 - Elimination of Cardiac and Inflammatory Biomarkers and Adipokines by Therapeutic Plasma Exchange N/A
Completed NCT04367610 - Effects of A Standardized Treatment Approach on Kidney Transplant Recipients With Antibody-Mediated Rejection
Completed NCT05021484 - Felzartamab in Late Antibody-Mediated Rejection Phase 2
Terminated NCT02120482 - Combined Apheresis for ABO-incompatible Transplantation - a Pilot Study N/A
Terminated NCT03744910 - Clazakizumab for the Treatment of Chronic Active Antibody Mediated Rejection in Kidney Transplant Recipients Phase 3
Terminated NCT03221842 - Efficacy and Safety of Human Plasma-derived C1-esterase Inhibitor as add-on to Standard of Care for the Treatment of Refractory Antibody Mediated Rejection (AMR) in Adult Renal Transplant Recipients Phase 3
Terminated NCT01895127 - Efficacy and Safety of Eculizumab for Treatment of Antibody-mediated Rejection Following Renal Transplantation Phase 2
Completed NCT02013037 - The De-novo Use of Eculizumab in Presensitized Patients Receiving Cardiac Transplantation Phase 3
Recruiting NCT03737136 - Comparison Between Bortezomib and Rituximab Plus Plasmapheresis in AMR N/A
Recruiting NCT05913596 - The Safety and Efficacy of CD38 Monoclonal Antibody Monotherapy for CaAMR in Renal Transplantation N/A
Active, not recruiting NCT04541914 - Diagnostic Efficacy of Molecular Diagnostic Method for AMR in ABOiKT N/A
Withdrawn NCT03805178 - Lung Transplant Plasmapheresis/Belatacept/Carfilzomib for Antibody Mediated Rejection and Desensitization Phase 2
Recruiting NCT06112951 - A Prospective Randomized Trial of ECP in Subclinical AMR N/A
Active, not recruiting NCT04897438 - Donor-derived Cell-free DNA for Early Diagnosis of Antibody-mediated Rejection N/A
Completed NCT04026087 - Subclass of Donor-specific Antibody as a Risk Factor of Antibody Mediated Rejection in Renal Transplantation
Active, not recruiting NCT03994783 - Transplant Antibody-Mediated Rejection: Guiding Effective Treatments Phase 3
Not yet recruiting NCT05862766 - Isatuximab in Lung Transplant Recipients Early Phase 1
Recruiting NCT04368962 - DSA Risk Factors in MMF-based Immunosuppressed Post-transplanted Patients
Completed NCT03444103 - A Pilot Trial of Clazakizumab in Late ABMR Phase 2
Recruiting NCT05140018 - Incidence, Course and Outcome of ABMR in Kidney Transplantation