Clinical trials: Antibody Mediated
End Stage Renal Disease, Antibody Mediated Rejection
Belatacept in Kidney Transplantation of Moderately Sensitized Patients
The purpose of this study is to evaluate the safety and effectiveness of an immunosuppressive medication, Belatacept, as a replacement for a calcineurin inhibitor, in combination with a standard of care regimen of…
- Trial name
- BelatPilot (NCT02130817)
- Testing
- Belatacept, Tacrolimus withdrawal, Plasmapheresis/Intravenous Immunoglobulin G
- Where
- United States
- Sponsor
- University of Wisconsin, Madison
Hemophilia A, Gene Therapy
Gene Therapy Study in Severe Hemophilia A Patients With Antibodies Against AAV5
This study is being conducted by BioMarin Pharmaceutical Inc. as an open label, single dose study to determine the safety of valoctocogene roxaparvovec (an Adenovirus-Associated Virus (AAV) based gene therapy vector) in severe…
- Conditions
- Hemophilia A, Gene Therapy, Clotting Disorders, Blood Disorder
- Trial name
- GENEr8-AAV5+ (NCT03520712)
- Testing
- Valoctocogene Roxaparvovec
- Where
- 9 sites in South Africa, South Korea and 2 more
- Volunteers
- 3 people
- Sponsor
- BioMarin Pharmaceutical
Antineutrophilic Cytoplasmic Antibody (ANCA)- Associated Vasculitis (AAV), Idiopathic Inflammatory Myositis (IIM)
A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease
This is a phase 1 study designed to evaluate the safety, pharmacokinetics (PK), and anti-B-cell activity of FT819 following treatment with or without auxiliary medicinal product (AMP) in participants with moderate-to-severe…
- Conditions
- Antineutrophilic Cytoplasmic Antibody (ANCA)- Associated Vasculitis (AAV), Idiopathic Inflammatory Myositis (IIM), Systemic Sclerosis (SSc), Systemic Lupus Erythematosus (SLE)
- Trial name
- NCT06308978
- Testing
- FT819, Fludarabine, Cyclophosphamide
- Where
- 21 sites in United States, France and 2 more
- Volunteers
- 244 people
- Sponsor
- Fate Therapeutics
Kidney Transplantation
Eculizumab for Prevention of Antibody-Mediated Rejection in ABO-Incompatible Living Donor Kidney Transplantation
The aim of this study is to determine whether a single dose of eculizumab can effectively prevent antibody-mediated rejection in recipients undergoing living donor kidney transplantation with a different ABO blood group type than…
- Trial name
- NCT06453135
- Testing
- Eculizumab
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Tao Lin
Hemolytic Anemia
The Safety of Repurposing Daratumumab for Relapsed or Refractory Autoimmune Antibody Mediated Hemolytic Anemia
A single-arm study utilizing a 6 x 4 expansion design using daratumumab SC treatment for patients with refractory Autoimmune Hemolytic Anemia.
- Trial name
- DARA-AIHA (NCT05004259)
- Testing
- Daratumumab / Hyaluronidase Injection
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Dartmouth-Hitchcock Medical Center
Solid Tumor, Adult
First-in-Human Study of the GDF-15 Neutralizing Antibody Visugromab (CTL-002) in Patients With Advanced Cancer (GDFATHER)
The Phase 1 part (Part A) is a dose escalation study of IV visugromab (CTL-002, a monoclonal antibody neutralizing GDF-15) as monotherapy and in combination with an approved checkpoint inhibitor (CPI) in patients with advanced…
- Trial name
- GDFATHER (NCT04725474)
- Testing
- visugromab (CTL-002), nivolumab
- Where
- 13 sites in Germany, Spain and 1 more
- Volunteers
- 199 people
- Sponsor
- CatalYm GmbH
Renal Transplant Rejection, Pediatric Kidney Disease
VIRTUUS Children's Study
The objective of the VIRTUUS Children's Study is to adapt identified and validated adult noninvasive diagnostic and prognostic biomarkers for the characterization of allograft status in pediatric recipients of kidney allografts.
- Conditions
- Renal Transplant Rejection, Pediatric Kidney Disease, End Stage Renal Disease, Nephropathy
- Trial name
- VIRTUUS (NCT03719339)
- Where
- 13 sites in United States, Canada
- Volunteers
- 445 people
- Sponsor
- Children's Hospital of Philadelphia
Asthma
Retrospective Analysis of Systemic Glucocorticoid Mediated Long-term Effects, Patient Pathways and Economic Burden Across Multiple Indications
Glucocorticoids are important in the treatment of many inflammatory, allergic, immunologic, and malignant disorders. However, the adverse effects of systemic corticosteroids are one of the most common causes of iatrogenic…
- Trial name
- NCT06488703
- Where
- Germany
- Volunteers
- 107,032 people
- Sponsor
- GlaxoSmithKline
Late Rejection of Renal Transplant, Antibody-mediated Rejection
Bortezomib in Late Antibody-mediated Kidney Transplant Rejection
Late antibody-mediated rejection (AMR) after kidney transplantation is defined as a separate rejection entity. So far, no appropriate treatment has been established for this rejection type.
- Trial name
- BORTEJECT (NCT01873157)
- Testing
- Bortezomib
- Where
- Austria
- Volunteers
- 44 people
- Sponsor
- Medical University of Vienna
Transplant Failure, Heart Transplant Rejection
MuLtimodality EvaluatiOn of aNtibody mEdiated Damage in Heart Transplantation (LEONE-HT)
Cross-sectional evaluation of antibody mediated injury in heart transplantation patients through a multimodal approach: electron microscopy, optic microscopy, immunohistochemistry techniques, transthoracic echocardiography…
- Conditions
- Transplant Failure, Heart Transplant Rejection, Antibody-mediated Rejection
- Trial name
- LEONE-HT (NCT05184426)
- Testing
- Echocardiogram, Cardiac magnetic resonance, Coronary angiography
- Where
- 3 sites in Spain
- Volunteers
- 90 people
- Sponsor
- Juan Francisco Delgado Jimenez
Renal Transplant Rejection
Fostamatinib in the Treatment of Chronic Active Antibody Mediated Rejection
A Phase 2, Pilot Study to Assess the Safety and Efficacy of Fostamatinib in the Treatment of Chronic Active Antibody Mediated Rejection in Renal Transplantation
- Trial name
- FOSTAMR (NCT03991780)
- Testing
- Fostamatinib
- Where
- United Kingdom
- Volunteers
- 8 people
- Sponsor
- Imperial College London
Antibody-Mediated Rejection, Kidney Transplantation
Phase 2 Study of ALXN2030 in Patients With Antibody-Mediated Rejection After Kidney Transplantation
The primary objective of this study is to evaluate the efficacy of ALXN2030 compared with placebo on biopsy proven histologic resolution in participants with active or chronic active antibody-mediated rejection (AMR) at Week 52.
- Conditions
- Antibody-Mediated Rejection, Kidney Transplantation, Biopsy-proven Histologic Scores, AMR
- Trial name
- CONCORD (NCT06744647)
- Testing
- ALXN2030
- Where
- 51 sites in United States, Brazil and 6 more
- Volunteers
- 47 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Pure Red-Cell Aplasia, Chronic Kidney Failure
Surveillance Study to Estimate the Incidence of Pure Red Blood Cell Aplasia Among Patients With Chronic Kidney Failure
The purpose of this study is to estimate the incidence rate of pure red cell aplasia (PRCA; aplastic anemia) mediated by erythropoietin (EPO) antibodies in patients who are receiving subcutaneous (s.c.) epoetin alfa (polysorbate…
- Trial name
- PRIMS (NCT00391287)
- Where
- 387 sites in Australia, Belgium and 13 more
- Volunteers
- 15,334 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Limbic Encephalitis With LGI1 Antibodies
Antibody-mediated LGI1 Encephalitis: Symptoms, Biomarkers, and Mechanisms of the Chronic Phase of the Disease
The encephalitis mediated by antibodies against Leucine-rich, glioma inactivated 1 protein (anti-LGI1 encephalitis) predominantly affects men (M:F, 6:4) and mostly older than 60 years.
- Trial name
- NCT06515106
- Testing
- Remote cognitive rehabilitation program
- Where
- Spain
- Volunteers
- 20 people
- Sponsor
- Fundacion Clinic per a la Recerca Biomédica
Antibody-mediated Rejection, Humoral Rejection
Efficacy and Safety of Eculizumab for Treatment of Antibody-mediated Rejection Following Renal Transplantation
This is an open-label analysis that will compare eculizumab versus Plasmapheresis (PP) and Immunoglobulin (IVIg) for the treatment of antibody-mediated rejection (AMR) in renal transplant recipients.
- Trial name
- NCT01895127
- Testing
- Eculizumab, Immunoglobulin, Plasmapheresis
- Where
- 3 sites in United States
- Volunteers
- 11 people
- Sponsor
- Brigham and Women's Hospital
Renal Transplantation
Endothelial Microparticules and Antibody Mediated Rejection and Kidney Transplantation: Biomarker of Antibody-mediated Rejection in Kidney Transplantation
Context and rationale: Antibody-mediated rejection is the leading cause of long-term renal graft loss. It's due to the production by the recipient of antibodies directed against antigens (belonging or not to the HLA system)…
- Trial name
- MICROMARK RJ (NCT03098238)
- Testing
- Biological sample
- Where
- France
- Volunteers
- 249 people, healthy volunteers welcome
- Sponsor
- University Hospital, Montpellier
Melanoma
Study of DS-8273a With Nivolumab in Unresectable Stage III or Stage IV Melanoma
The purpose of this study is to evaluate the safety profile, tolerability, and immunoregulatory (pharmacodynamic; PD) activity of DS-8273a administered in combination with nivolumab (anti-PD-1 antibody) to subjects with…
- Trial name
- NCT02983006
- Testing
- DS-8273a, Nivolumab
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- NYU Langone Health
Immunoglobulin E-Mediated Food Allergy, Immunoglobulin G4-Related Disease
Immunoglobulin G4 and Immunoglobulin E Antibodies in a Population With Adverse Reactions to Foodstuffs-related Symptoms
The aim of this study is to analyze a population with symptoms associated with adverse reactions to foodstuffs (ARFS). To determine the levels of food-specific immunoglobulin G4 (IgG4) and immunoglobulin E (IgE) antibody…
- Conditions
- Immunoglobulin E-Mediated Food Allergy, Immunoglobulin G4-Related Disease, Symptoms and Signs, Adverse Reaction to Food
- Trial name
- NCT05681975
- Testing
- Food-specific Immunoglobulin G4 and/or Immunoglobulin E antibody reactions
- Where
- Spain
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Universidad Politecnica de Madrid
Kidney; Complications, Allograft, Transplantation Infection
The Role of B Cells in Kidney Allograft Dysfunction
The purpose of this study is to understand the role of specific B cells in activating or repressing an anti-allograft immune response after kidney transplantation.
- Trial name
- NCT02294032
- Testing
- Immunosuppressive Agents
- Where
- United States
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Loma Linda University
Antibody Mediated Rejection
A Two Part Dose-escalation Safety and Efficacy Study of CID-103 in Adults With Active and Chronic Active Renal Allograft Antibody Mediated Rejection (ABMR).
The goal of the global Phase 1/2 clinical trial is to evaluate whether CID-103, a novel anti-CD38 monoclonal antibody, is safe and effective in adults with with active and chronic active renal allograft antibody mediated…
- Trial name
- NCT07641426
- Testing
- CID-103
- Where
- 4 sites in China
- Volunteers
- 58 people
- Sponsor
- CASI pharmaceuticals, Inc.