Clinical trials: Antibody Mediated
Kidney Tansplant, Acute Rejection (AR) of Transplanted Kidney
Daratumumab for Late Antibody-Mediated Rejection
The study titled "Daratumumab for Late Antibody-Mediated Rejection in Kidney Transplant Recipients with De Novo Donor-Specific Antibodies" (DARTABMR) is a case-control investigation assessing whether daratumumab is more effective…
- Trial name
- DARTABMR (NCT07081126)
- Testing
- Daratumumab (Subcutaneously), control group
- Where
- Slovakia
- Volunteers
- 20 people
- Sponsor
- University Hospital, Martin
Pregnancy Related, Immune-mediated Diseases
Impact of In Utero Exposure to Immunomodulatory Drugs on Neonatal Immune System Development
What is this project about? This project aims to better understand how the immune system develops in babies whose mothers received immunomodulatory treatments during pregnancy.
- Trial name
- NEWbornIMMPACT (NCT07033663)
- Testing
- Monoclonal antibody
- Where
- 3 sites in Spain
- Volunteers
- 90 people
- Sponsor
- Fundació Sant Joan de Déu
Viral Vaccines, Chikungunya Fever
Chikungunya Virus Vaccine Trial in Healthy Adults
Background: Chikungunya virus (CHIKV) is transmitted by mosquitoes. It can cause fever, headache, muscle pain, fatigue, and joint pain. The disease usually does not cause death.
- Conditions
- Viral Vaccines, Chikungunya Fever, Chikungunya Virus Infection
- Trial name
- NCT01489358
- Testing
- VRC-CHKVLP059-00-VP
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Myasthenia Gravis, Systemic Lupus Erythematosus
Therapy of Antibody-mediated Autoimmune Diseases by Bortezomib (TAVAB)
The aim of this pilot study is to investigate the application of proteasome inhibitor Bortezomib (Velcade®, approved for therapy of multiple myeloma) in patients with therapy-refractory antibody-mediated autoimmune diseases.
- Conditions
- Myasthenia Gravis, Systemic Lupus Erythematosus, Rheumatoid Arthritis
- Trial name
- TAVAB (NCT02102594)
- Testing
- Bortezomib
- Where
- 2 sites in Germany
- Volunteers
- 11 people
- Sponsor
- Charite University, Berlin, Germany
Food Allergy
Expanded Access of Dupilumab in Adults With Severe Immunoglobulin E (IgE)-Mediated Food Allergy Previously Treated With Linvoseltamab
This is an expanded access program of dupilumab. The objective of the program is to provide continued dupilumab to adult participants with severe IgE-mediated food allergy who were previously treated with a short course of…
- Trial name
- NCT06631677
- Testing
- Dupilumab
- Sponsor
- Regeneron Pharmaceuticals
Kidney Transplant Rejection
An Efficacy and Safety Study of Imlifidase in Treatment of Antibody-Mediated Rejection in Kidney Transplant Patients
The purpose of this study was to investigate how efficiently the study medication imlifidase reduces the amount of donor specific antibodies (DSA) in comparison with plasma exchange (PE) therapy, in patients who have had an…
- Trial name
- NCT03897205
- Testing
- Imlifidase, Plasma Exchange
- Where
- 14 sites in United States, Australia and 3 more
- Volunteers
- 30 people
- Sponsor
- Hansa Biopharma AB
Primary Membranous Nephropathy
A Study to Assess the Effect of Surovatamig in Adult Participants With Antibody-mediated Kidney Disease
The purpose of this study is to assess the safety, tolerability, pharmacokinetic, and efficacy of surovatamig administered by subcutaneous injection in adult participants with primary membranous nephropathy.
- Trial name
- CLEAR-AbKD (NCT07571746)
- Testing
- Surovatamig
- Where
- 27 sites in United States, Belgium and 7 more
- Volunteers
- 43 people
- Sponsor
- AstraZeneca
COVID-19, Antibody COVID-19
The Role of Obesity in Severe COVID-19 Pathophysiology
The coronavirus disease 2019 (COVID-19) pandemic, caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has resulted in millions of deaths worldwide.
- Trial name
- SAMO (NCT06968442)
- Testing
- Venipuncture
- Where
- Netherlands
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Franciscus Gasthuis
Respiratory Syncytial Virus
Dose, Safety, Tolerability and Immunogenicity of a Stabilized Prefusion RSV F Subunit Protein Vaccine, VRC-RSVRGP084-00-VP (DS-Cav1), Alone or With Alum Adjuvant, in Healthy Adults
Background: Respiratory Syncytial Virus (RSV) is a virus that infects the lungs and breathing passages. Healthy adults who are infected generally have mild cold symptoms for a week or two.
- Trial name
- NCT03049488
- Testing
- VRC-RSVRGP084-00-VP, Aluminum Hydroxide Suspension
- Where
- United States
- Volunteers
- 95 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Immunity to Influenza Vaccine
Cell Mediated Immunity in Older Adults
This study is to study the immune response to the flu vaccine in people 65 years old and older. Only adults 65 years old and older and who are getting their flu vaccine are being asked to join in this study.
- Trial name
- CMI (NCT01189123)
- Testing
- High dose influenza vaccine Sanofi-Pasteur, fluzone by sanofi pasteur
- Where
- United States
- Volunteers
- 105 people, healthy volunteers welcome
- Sponsor
- Vanderbilt University
Autoimmune Diseases, Systemic Lupus Erthematosus (SLE)
CAR T-cell Therapy Targeting CD19 and BCMA in Patients With B Cell Mediated Autoimmune Disease
CAR T-cell Therapy Targeting CD19 and BCMA in Patients With B cell mediated autoimmune disease.
- Conditions
- Autoimmune Diseases, Systemic Lupus Erthematosus (SLE), Multi-Drug Resistant Nephrotic Syndrome, IgA Nephropathy (IgAN)
- Trial name
- NCT07305116
- Testing
- UCAR T-cell
- Where
- China
- Volunteers
- 15 people
- Sponsor
- The Children's Hospital of Zhejiang University School of Medicine
Glomerulonephritis
Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of KP104 to Treat Glomerulonephritis
The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and pharmacodynamics (PD) of KP104 in participants with IgAN and C3G. The study will start with enrolling the IgAN cohort.
- Trial name
- NCT05517980
- Testing
- KP104
- Where
- China
- Volunteers
- 52 people
- Sponsor
- Kira Pharmacenticals (US), LLC.
Kidney Transplant
Adipose-derived MSC to Treat Rejection in Kidney Transplant Recipients
This research study is being done to learn if an experimental treatment of infusing allogeneic adipose-derived mesenchymal stromal cells (allo-A-MSC ) directly into the renal artery is safe and can help reduce inflammation in the…
- Trial name
- NCT05456243
- Testing
- Low dose adipose tissue derived mesenchymal stromal cells (A-MSC), High dose adipose tissue derived mesenchymal stromal cells (A-MSC)
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Mayo Clinic
Lupus Erythematosus, Systemic Lupus Erythematosus
Study Evaluating SC291 in Subjects With Severe r/r B-cell Mediated Autoimmune Diseases (GLEAM)
SC291-102 is a Phase 1 study to evaluate SC291 safety and tolerability, preliminary clinical response, cellular kinetics and exploratory assessments for subjects with severe autoimmune diseases.
- Conditions
- Lupus Erythematosus, Systemic Lupus Erythematosus, SLE (Systemic Lupus), Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
- Trial name
- NCT06294236
- Testing
- SC291
- Where
- 5 sites in United States
- Volunteers
- 7 people
- Sponsor
- Sana Biotechnology
Covid19
Safety, Tolerability, and Immunogenicity of the COVID-19 Vaccine Candidates VBI-2902a and VBI-2905a
VBI-2902a and VBI-2905a are investigational vaccine candidates that use enveloped virus-like particle (eVLP) expression of a modified version of the SARS-CoV-2 spike (S) glycoprotein and are designed to induce neutralizing…
- Trial name
- NCT04773665
- Testing
- VBI-2902a, VBI-2905a
- Where
- 4 sites in Canada
- Volunteers
- 114 people, healthy volunteers welcome
- Sponsor
- VBI Vaccines Inc.
Antibody-mediated Rejection, Antibody-Mediated Rejection (AMR)
Sequential Daratumumab Followed by Telitacicept for the Treatment of ABMR After Kidney Transplantation-A Phase IIa Clinical Trial
The goal of this clinical trial is to: a. To evaluate the safety and efficacy of sequential daratumumab followed by telitacicept in kidney transplant recipients with active/chronic active ABMR in participants aged 18-70 years…
- Trial name
- STABILIZE (NCT07902609)
- Testing
- Methylprednisolone (MP), Daratumumab, Telitacicept
- Where
- China
- Volunteers
- 20 people
- Sponsor
- First Affiliated Hospital, Sun Yat-Sen University
Small Fiber Neuropathy, Autoimmune Small Fiber Neuropathy
IVIG in the Treatment of Autoimmune Small Fiber Neuropathy With TS-HDS, FGFR-3, or Plexin D1 Antibodies
This study will enroll patients with small fiber neuropathy (SFN). The study will look at an intravenous immunoglobulin (IVIG) called Panzyga.
- Conditions
- Small Fiber Neuropathy, Autoimmune Small Fiber Neuropathy, Inflammatory Polyneuropathy, Immune-Mediated Neuropathy
- Trial name
- NCT04153422
- Testing
- Panzyga IVIG
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Endeavor Health
Kidney Transplantation
Chronic Transplant Glomerulopathy and Regulation of Expression of Ephrin B1
The principal purpose is the study of the regulation of the expression of ephrin-B1 by immunofluorescence in kidney biopsies of patients with Chronic transplant glomerulopathy (CTG) compared to biopsies prior to the CTG, in same…
- Trial name
- GARRE (NCT02147210)
- Testing
- biological analysis
- Where
- France
- Volunteers
- 60 people
- Sponsor
- University Hospital, Toulouse
Kidney Transplant Rejection
Screening for Subclinical Antibody Mediated Rejection and Efficacy of Belatacept in the Context of de Novo Donor Specific Antibody After Kidney Transplantation (BELA-M-R)
Antibody mediated rejection (ABMR) is a major cause of graft loss after kidney transplantation (KT) and is mainly associated with preformed anti-HLA donor specific antibodies (DSAs) (phenotype 1) or de novo DSAs (dnDSAs)…
- Trial name
- BELA-M-R (NCT06291103)
- Testing
- Conversion to Belatacep, Standard of care treatment (SOC regimen) with Tacrolimus
- Where
- France
- Volunteers
- 290 people
- Sponsor
- University Hospital, Rouen
Antibody-mediated Rejection
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)
The purpose of this study is to assess the safety, tolerability, and efficacy of efgartigimod PH20 SC given by a prefilled syringe in participants with Antibody-Mediated Rejection (AMR) after kidney transplantation.
- Trial name
- Shamrock (NCT06503731)
- Testing
- Efgartigimod PH20 SC - prefilled syringe
- Where
- 23 sites in United States, Austria and 6 more
- Volunteers
- 33 people
- Sponsor
- argenx