Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting study of Antibody-mediated Rejection and CIDP, sponsored by Charles M Knudson.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The effect of replacement fluids on IgG and IgM antibody levels will be examined.
Conditions Studied
Study Locations (1)
Iowa
- DeGowin blood Center - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2021-07-28 |
| Est. Completion | 2040-12-31 |
What NCT05004493 shows while recruiting
NCT05004493 is an observational study that tracks outcomes without assigning an intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, above the 132-participant average among 5 other Antibody-mediated Rejection trials with a reported enrollment target (52% higher).
The record links to 4 conditions, with Antibody-mediated Rejection appearing as the primary indexed condition, and to 0 interventions.
NCT05004493 reports a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Antibody-mediated Rejection
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
A Study to Learn More About the Effects and Safety of Felzartamab Infusions in Adults With Kidney Transplants Who Have Antibody-Mediated Rejection (AMR)
RECRUITING · Phase 3
-
A Study to Evaluate the Safety and Tolerability of Efgartigimod PH20 SC Given by Prefilled Syringe in Kidney Transplant Recipients With Antibody-Mediated Rejection (AMR)
RECRUITING · Phase 2
-
Phase 2 Study of ALXN2030 in Patients With Antibody-Mediated Rejection After Kidney Transplantation
RECRUITING · Phase 2
-
Clazakizumab in Highly-HLA Sensitized Patients Awaiting Renal Transplant
ACTIVE NOT RECRUITING · Phase 1
-
VIRTUUS Children's Study
ACTIVE NOT RECRUITING
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00107289 · 200 participants · Phase 2
Iodine I 131 Metaiodobenzylguanidine in Treating Patients With Recurrent, Progressive, or Refractory Neuroblastoma or Malignant Pheochromocytoma or Paraganglioma
- NCT00109174 · 200 participants · NA
MRS Measurement of Glutamate and GABA Metabolism in Brain
- NCT00177268 · 200 participants
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
- NCT00493688 · 200 participants
A Study to Determine Whether Perioperative Energy Dynamics Correlates With Postoperative Outcomes
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI