Clinical trials: Antibody Mediated
Antibody Mediated Rejection of Lung Transplant
A Phase 1 Clinical Trial of Siltuximab for the Treatment of Antibody-Mediated Rejection After Lung Transplantation
Antibody-mediated rejection after lung transplantation commonly results in allograft failure and death in spite of current therapeutic regimens.
- Trial name
- Siltux-AMR (NCT06990711)
- Testing
- Siltuximab
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- Washington University School of Medicine
Heart Transplant, Pediatric Heart Transplant
Non-invasive Prediction of EArly Cardiac rEjection
Acute rejection remains a major cause of morbidity and mortality in pediatric patients after heart transplant. In order to screen for rejection, most centers perform heart catheterizations with endomyocardial biopsies frequently…
- Conditions
- Heart Transplant, Pediatric Heart Transplant, Rejection, Cardiac MRI
- Trial name
- PEACE (NCT07770659)
- Where
- 22 sites in United States
- Volunteers
- 200 people
- Sponsor
- Vanderbilt University Medical Center
Multiple Myeloma
Autologous Memory-like NK Cell Therapy With BHV-1100 and Low Dose IL-2 in Multiple Myeloma Patients
This is an open-label single center Phase 1a/1b study with the primary objective of establishing the safety and exploring the efficacy of infusing the ex vivo combination product of BHV-1100 plus cytokine induced memory-like…
- Trial name
- NCT04634435
- Testing
- BHV-1100 plus cytokine induced memory-like (CIML) NK cells plus IVIG and low dose IL-2
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Biohaven Pharmaceuticals, Inc.
Antibody-mediated Rejection, Kidney Transplant; Complications
Clazakizumab for Chronic and Active Antibody Mediated Rejection Post-Kidney Transplant
Antibody mediated rejection (ABMR) is a unique, significant and often severe form of allograft rejection. This single center, phase I/II, open label single-arm exploratory study focuses on enrolling ten patients with biopsy…
- Conditions
- Antibody-mediated Rejection, Kidney Transplant; Complications, Transplant Glomerulopathy, Transplant Glomerulopathy - Late Form
- Trial name
- NCT03380377
- Testing
- Clazakizumab
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Stanley Jordan, MD
Kidney Transplant Failure and Rejection
AlloSure for the Monitoring of Antibody Mediated Processes After Kidney Transplantation
This is a prospective cohort observational study to assess the role of AlloSure Donor Derived Cell Free DNA (ddcfDNA) assay in the monitoring of three high-risk groups of kidney transplant patients for antibody mediated…
- Trial name
- All-MAP (NCT04057742)
- Testing
- AlloSure ddcfDNA assay, AlloMap assay, Inflammatory Cytokines
- Where
- United States
- Volunteers
- 52 people
- Sponsor
- University of Wisconsin, Madison
Antibody-mediated Rejection
Subclass of Donor-specific Antibody as a Risk Factor of Antibody Mediated Rejection in Renal Transplantation
Antibody-mediated rejection is now recognized as the first cause of long-term kidney transplant loss. This type of rejection is mediated by the presence of graft-specific antibodies, usually directed against HLA (Human Leukocyte…
- Trial name
- COR-HUM (NCT04026087)
- Where
- France
- Volunteers
- 100 people
- Sponsor
- University Hospital, Montpellier
Chikungunya Virus Infection
Trial for Safety and Immunogenicity of a Chikungunya Vaccine, VRC-CHKVLP059-00-VP, in Healthy Adults
This is a multicenter, randomized, placebo-controlled, double-blind study to evaluate the safety and immunogenicity of a 2-injection vaccine Chikungunya virus (CHIKV) virus-like particle vaccine (CHIKV VLP) in healthy adults.
- Trial name
- NCT02562482
- Testing
- VRC-CHKVLP059-00-VP, VRC-PBSPLA043-00-VP
- Where
- 6 sites in Dominican Republic, Guadeloupe and 3 more
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Warm Autoimmune Hemolytic Anemia
Subcutaneous ALXN1830 in Adult Participants With Warm Autoimmune Hemolytic Anemia
This is a Phase 2, multiple ascending, dose-finding, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, health-related quality of life, tolerability, pharmacokinetic, pharmacodynamic, and…
- Trial name
- NCT04956276
- Testing
- ALXN1830
- Where
- United States
- Sponsor
- Alexion Pharmaceuticals, Inc.
Sensitized Kidney Transplant Recipients
Identification of Donor Specific B Cells and Antibody Mediated Rejection
Many people who are on the wait list for a kidney transplant have harmful antibodies, called donor specific antibodies (DSA), which will attack foreign tissue such as the transplanted organ.
- Trial name
- NCT02133248
- Where
- United States
- Volunteers
- 86 people, healthy volunteers welcome
- Sponsor
- University of Wisconsin, Madison
Chronic Antibody-mediated Rejection (cABMR)
Allogeneic Umbilical Cord Mesenchymal Stromal Cells for the Treatment of Chronic Antibody-Mediated Rejection in Kidney Transplantation
Kidney transplantation is the best treatment for end-stage chronic kidney disease (CKD), improving survival and quality of life, while reducing treatment costs.
- Trial name
- SCARR (NCT06886646)
- Testing
- Allogeneic Mesenchymal Stromal Cell Therapy
- Where
- France
- Volunteers
- 22 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Subclinical Acute Antibody-mediated Rejection in Kidney Transplantation
Eculizumab Therapy for Subclinical Antibody-mediated Rejection in Kidney Transplantation
Advances in renal transplantation have increased life-expectancy in patients with end-stage kidney disease. Conventional immunosuppressive drugs prevent efficiently early allograft losses due to T-cell mediated rejection.
- Trial name
- TAMARCIN (NCT02113891)
- Testing
- Eculizumab
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Kidney Transplantation, Antibody Mediated Rejection
Treatment of Chronic Active Antibody Mediated Rejection After Kidney Transplantation by Double-Filtration PlasmaPheresis or Plasma Exchange
In France around 90,000 cases of end-stage chronic kidney disease patients treated either by dialysis (60%) or renal transplantation (just over 40%).
- Trial name
- DFPP (NCT03436134)
- Testing
- Sessions of conventional apheresis, Sessions of news apheresis with double filtration
- Where
- France
- Volunteers
- 16 people
- Sponsor
- University Hospital, Grenoble
Anti-3-hydroxy-3-methylglutaryl-CoA Reductase (HMGCR) Immune-Mediated Necrotizing Myopathy
The MIGHT Trial - An Exploratory Clinical Trial of IVIG in Anti-HMGCR Immune Mediated Necrotizing Myopathy
This is a randomized, placebo-controlled, double blinded phase 2 exploratory clinical trial of intravenously administered pooled human immunoglobulin (IVIG) in anti-3-hydroxy-3-methylglutaryl-CoA reductase (HMGCR) immune mediated…
- Trial name
- NCT06599697
- Testing
- Intravenously administered pooled human immunoglobulin (IVIG)
- Where
- 5 sites in United States
- Volunteers
- 12 people
- Sponsor
- University of Alabama at Birmingham
Antibody-mediated Rejection, Autoimmune Reaction Mediated by Immune Complex
Elimination of Cardiac and Inflammatory Biomarkers and Adipokines by Therapeutic Plasma Exchange
Therapeutic plasma exchange (TPE) is an established treatment modality for the acute removal of pathophysiological relevant mediators in various diseases.
- Trial name
- NCT02533596
- Where
- Germany
- Volunteers
- 21 people
- Sponsor
- Hannover Medical School
Kidney Transplant Rejection
ddcfDNA in Kidney Transplant Recipients
The objective of this study is to predict subclinical Antibody-Mediated Rejection (ABMR) occurrences in de novo DSA-positive recipients maintaining stable renal function after transplantation.
- Trial name
- NCT06013358
- Testing
- AlloSeq cfDNA
- Where
- South Korea
- Volunteers
- 200 people
- Sponsor
- Seoul National University Hospital
Kidney Failure, Chronic, End-Stage Renal Disease
Clazakizumab in Highly-HLA Sensitized Patients Awaiting Renal Transplant
Patients who have had a previous allograft failure represent a major problem for transplant centers as they are highly-human leukocyte antigen (HLA) sensitized and unlikely to receive another transplant without significant…
- Conditions
- Kidney Failure, Chronic, End-Stage Renal Disease, Transplant Glomerulopathy, Transplant;Failure,Kidney
- Trial name
- NCT03380962
- Testing
- Clazakizumab
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Stanley Jordan, MD
Kidney Transplant Rejection, Antibody-mediated Rejection
Donor-derived Cell-free DNA for Early Diagnosis of Antibody-mediated Rejection
Patients after kidney transplantation who develop donor-specific antibodies (DSA) are at high risk for antibody-mediated rejection (ABMR).
- Conditions
- Kidney Transplant Rejection, Antibody-mediated Rejection, Kidney Transplant Failure
- Trial name
- cfDNA-DSA (NCT04897438)
- Testing
- Kidney allograft biopsy depending on donor-derived cell-free DNA levels
- Where
- Germany
- Volunteers
- 40 people
- Sponsor
- Charite University, Berlin, Germany
Antibody-mediated Rejection, Lung Transplant Rejection
A Prospective Randomized Trial of ECP in Subclinical AMR
The goal of this clinical trial is to evaluate the therapeutic effect of extracorporeal photopheresis in subclinical antibody-mediated rejection after lung transplantation.The main questions it aims to answer are: 1.
- Trial name
- EUROEXPORT-DSA (NCT06112951)
- Testing
- Extracorporeal Photopheresis
- Where
- 7 sites in Austria, Belgium and 5 more
- Volunteers
- 80 people
- Sponsor
- Medical University of Vienna
Atopic Immunoglobulin E-Mediated Allergic Disorder
A Phase 1b Study of STMC-103H in Multi-Sensitized Allergic Subjects Who Are Otherwise Healthy
The primary objective of this study is to assess the safety and tolerability of STMC-103H compared to placebo in allergic subjects who are otherwise healthy.
- Trial name
- NCT03819881
- Testing
- STMC-103H
- Where
- 2 sites in United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Siolta Therapeutics, Inc.
Heart Transplantation, Rejection Heart Transplant
CARdiac Imaging and BIomarkers in the Diagnosis of Antibody Mediated Rejection in Heart Transplantation
The goal of this observational study is to systematically assess the presence and distribution of CMR-defined inflammation and fibrosis in clinically stable HT recipients with DSA detected during active screening for AMR…
- Conditions
- Heart Transplantation, Rejection Heart Transplant, HLA Antigens
- Trial name
- CARIBIAM (NCT06774365)
- Where
- 4 sites in Italy
- Volunteers
- 683 people
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna