Clinical trials: Antibody Mediated
Kidney Transplant Rejection
An Long-term Follow-up Trial of Kidney Tx Patients Treated With Imlifidase or PE After an AMR
The aim of this trial is to collect data and provide a better understanding of the long-term outcome of imlifidase treatment on active or chronic active antibody-mediated rejection (AMR) in kidney transplant recipients.
- Trial name
- NCT04711850
- Testing
- Imlifidase
- Where
- 7 sites in Austria, France and 1 more
- Volunteers
- 18 people
- Sponsor
- Hansa Biopharma AB
Rheumatoid Arthritis
Drug Concentration, Immunogenicity, and Efficacy Study in Patients With Rheumatoid Arthritis Currently Treated With Etanercept, Adalimumab, or Infliximab
The purpose of this study is to examine the relationship between anti-drug antibodies, serum drug concentrations, and clinical response for rheumatoid arthritis patients being treated with etanercept, adalimumab or infliximab.
- Trial name
- ANTIBODY-RA (NCT01981473)
- Testing
- no intervention
- Where
- 54 sites in United States, Argentina and 3 more
- Volunteers
- 605 people
- Sponsor
- Pfizer
Antibody-mediated Rejection
Clazakizumab for the Treatment of Chronic Active Antibody Mediated Rejection in Kidney Transplant Recipients
This trial investigates the efficacy and safety of clazakizumab [an anti-interleukin (IL)-6 monoclonal antibody (mAb)] for the treatment of CABMR in recipients of a kidney transplant.
- Trial name
- IMAGINE (NCT03744910)
- Testing
- Clazakizumab, Physiologic saline solution
- Where
- 142 sites in United States, Australia and 13 more
- Volunteers
- 194 people
- Sponsor
- CSL Behring
Purpura, Thrombotic Thrombocytopenic
IdeS in Asymptomatic Antibody-Mediated Thrombotic Thrombocytopenic Purpura (TTP) Patients
The main purpose of this study is to evaluate safety and tolerability in patients diagnosed with asymptomatic antibody-mediated TTP with low ADAMTS13 activity after receiving single intravenous dose of IdeS.
- Trial name
- NCT02854059
- Testing
- IdeS (0.25 mg/kg), IdeS (0.50 mg/kg)
- Where
- United Kingdom
- Volunteers
- 2 people
- Sponsor
- Hansa Biopharma AB
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.
Chronic Kidney Diseases, Inflammation
Trial to Evaluate Reduction in Inflammation in Patients With Advanced Chronic Renal Disease Utilizing Antibody Mediated IL-6 Inhibition
Patients with chronic kidney disease, who have evidence of systemic inflammation with increased cardiovascular risk, will be enrolled into this trial.
- Trial name
- RESCUE (NCT03926117)
- Testing
- Ziltivekimab
- Where
- 49 sites in United States
- Volunteers
- 264 people
- Sponsor
- Novo Nordisk A/S
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
Acute Antibody-Mediated Rejection (AMR)
A Multicenter Study to Evaluate the Efficacy and Safety of Cinryze® for the Treatment of Acute Antibody-mediated Rejection in Participants With Kidney Transplant
The main purpose of the study is to evaluate the efficacy of CINRYZE administered with plasmapheresis, plasma exchange, or immune adsorption treatments and sucrose-free immunoglobulin (IVIg) for the treatment of acute…
- Trial name
- NCT02547220
- Testing
- Cinryze®
- Where
- 47 sites in United States, Canada and 4 more
- Volunteers
- 39 people
- Sponsor
- Shire
Antibody-mediated Rejection
Efficacy and Safety of Human Plasma-derived C1-esterase Inhibitor as add-on to Standard of Care for the Treatment of Refractory Antibody Mediated Rejection (AMR) in Adult Renal Transplant Recipients
This is a double-blind, randomized-withdrawal, placebo-controlled study in kidney transplant patients with AMR to evaluate the efficacy and safety of human plasma-derived C1-esterase inhibitor as add-on to standard of care (IVIG).
- Trial name
- NCT03221842
- Testing
- C1-esterase inhibitor
- Where
- 26 sites in United States, Belgium and 5 more
- Volunteers
- 63 people
- Sponsor
- CSL Behring
Herpes Zoster
Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster Vaccine With Various Formulations in Adults >= 50 Years
The goal of this randomized observer-blind trial is to further refine the formulation of vaccines containing GSK1437173A in older adults by comparing the cellular and humoral immune responses and the safety profiles of the…
- Trial name
- NCT00802464
- Testing
- Herpes zoster vaccine GSK1437173A
- Where
- 12 sites in United States, Czechia and 1 more
- Volunteers
- 410 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Allografts, Rejection; Transplant, Kidney
A Study to Evaluate the Safety and Efficacy of Dual Costimulation Blockade With VIB4920 and Belatacept for Prophylaxis of Allograft Rejection in Adults Receiving a Kidney Transplant
The purpose of this study is to evaluate the efficacy, safety and tolerability of dual costimulation blockade with VIB4920 in combination of belatacept in adult male or female recipients of a renal allograft from a deceased…
- Conditions
- Allografts, Rejection; Transplant, Kidney, Transplant Rejection, Kidney Transplantation
- Trial name
- NCT04046549
- Testing
- Belatacept, VIB4920, Thymoglobulin
- Where
- 4 sites in United States
- Volunteers
- 25 people
- Sponsor
- Amgen
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
Peanut Allergy
Efficacy and Safety of Viaskin Peanut in Children With Immunoglobulin E (IgE)-Mediated Peanut Allergy
The PEPITES study evaluates the efficacy and safety of Viaskin Peanut 250 µg peanut protein to induce desensitization to peanut in peanut-allergic children 4 through 11 years of age after a 12-month treatment by epicutaneous…
- Trial name
- PEPITES (NCT02636699)
- Testing
- Viaskin Peanut 250mcg
- Where
- 31 sites in United States, Australia and 3 more
- Volunteers
- 500 people
- Sponsor
- DBV Technologies
Anemia, Chronic Kidney Disease
Efficacy and Safety of Peginesatide (AF37702) in the Treatment of Anemia in Participants With Chronic Kidney Disease
The purpose of this study is to evaluate the ability of peginesatide (AF37702) to increase and maintain increased hemoglobin levels in participants with chronic kidney disease (CKD) (either not on dialysis, receiving regular…
- Conditions
- Anemia, Chronic Kidney Disease, Chronic Renal Failure, Pure Red Cell Aplasia
- Trial name
- NCT00314795
- Testing
- Peginesatide
- Where
- 4 sites in France, Germany and 1 more
- Volunteers
- 22 people
- Sponsor
- Takeda
Stage V Chronic Kidney Disease
Safety & Efficacy Of Eculizumab In The Prevention Of AMR In Sensitized Recipients Of A Kidney Transplant From A Deceased Donor
Primary Objective: To evaluate the safety and potential efficacy of eculizumab to prevent AMR in sensitized recipients of deceased donor kidney transplants.
- Trial name
- NCT01567085
- Testing
- Eculizumab
- Where
- 15 sites in Australia, France and 4 more
- Volunteers
- 80 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Antibody Mediated Rejection
Safety & Efficacy of Eculizumab to Prevent AMR in Living Donor Kidney Transplant Recipients Requiring Desensitization
The purpose of this trial was to determine the safety and efficacy of eculizumab in the prevention of antibody-mediated rejection (AMR) in sensitized recipients of a living donor kidney transplant requiring desensitization…
- Trial name
- NCT01399593
- Testing
- Eculizumab
- Where
- 41 sites in United States, Australia and 8 more
- Volunteers
- 102 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Chronic Kidney Disease, Inflammation
Trial to Evaluate Reduction in Inflammation in Patients With Advanced Chronic Renal Disease Utilizing Antibody Mediated IL-6 Inhibition in Japan.
The purpose of this research study is to compare the safety and effectiveness of 2 different doses of a study drug called ziltivekimab to placebo (an inactive substance) in reducing inflammation and improving some of the bad…
- Conditions
- Chronic Kidney Disease, Inflammation, Cardiovascular Risk
- Trial name
- RESCUE-2 (NCT04626505)
- Testing
- Ziltivekimab
- Where
- Japan
- Volunteers
- 36 people
- Sponsor
- Novo Nordisk A/S
Graft Rejection
A Pilot Study to Evaluate the Use of C1 Esterase Inhibitor (Human) in Patients With Acute Antibody-Mediated Rejection
The purpose of this research study is to evaluate the safety, effect, and pharmacology of C1 Esterase Inhibitor (human) in kidney transplant patients with acute Antibody-Mediated Rejection (AMR).
- Trial name
- NCT01147302
- Testing
- C1 Esterase Inhibitor (Human)
- Where
- 5 sites in United States, Germany
- Volunteers
- 18 people
- Sponsor
- Shire