NCT05004493 Biorepository and Registry for Plasma Exchange Patients
| NCT ID | NCT05004493 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Charles M Knudson |
| Condition | Antibody-mediated Rejection |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2021-07-28 |
| Primary Completion | 2030-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2021-07-28 with a primary completion date of 2030-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Pts undergoing plasma exchange therapy are eligible to be in this protocol
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05004493 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 99 Years, studying Antibody-mediated Rejection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05004493 currently recruiting?
Yes, NCT05004493 is actively recruiting participants. Contact the research team at c-knudson@uiowa.edu for enrollment information.
Where is the NCT05004493 trial being conducted?
This trial is being conducted at Iowa City, United States.
Who is sponsoring the NCT05004493 clinical trial?
NCT05004493 is sponsored by Charles M Knudson. The trial plans to enroll 200 participants.