Clinical trials: Antibody Mediated Rejection
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
Graft Rejection, Kidney Transplantation
Recombinant Human C1 Inhibitor for the Treatment of Early Antibody-Mediated Rejection in Renal Transplantation
The purpose of this study will be to assess the safety, tolerability, and efficacy of rhC1INH in renal transplant recipients with biopsy-confirmed antibody-mediated rejection (AMR) within 30 days of renal transplantation.
- Trial name
- NCT01035593
- Testing
- plasmapheresis and IVIG, recombinant C1 inhibitor
- Where
- United States
- Sponsor
- Pharming Technologies B.V.
Antibody-mediated Rejection
A Study to Learn More About the Effects and Safety of Felzartamab Infusions in Adults With Kidney Transplants Who Have Antibody-Mediated Rejection (AMR)
In this study, researchers will learn more about the use of felzartamab in kidney transplant patients who have antibody-mediated rejection, also known as AMR. Kidney transplants can save lives for people with kidney failure.
- Trial name
- TRANSCEND (NCT06685757)
- Testing
- Felzartamab
- Where
- 56 sites in United States, Argentina and 10 more
- Volunteers
- 132 people
- Sponsor
- Biogen
Antibody-Mediated Graft Rejection
Cell-based Assays for Antibody-mediated Transplant Rejection
Goal: The goal of this study is to validate blood tests, which can detect antibody-mediated rejection (ABMR) after renal transplantation.
- Trial name
- NCT03916822
- Testing
- Alloantigen-specific B-cells
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- Plexision
Antibody Mediated Rejection
Study of SG301 for Renal AMR After Transplantation
To evaluate the safety and tolerability of SG301 injection in patients with antibody-mediated rejection (AMR) after renal transplantation.
- Trial name
- NCT07764627
- Testing
- SG301 Injection
- Where
- 7 sites in China
- Volunteers
- 10 people
- Sponsor
- Hangzhou Sumgen Biotech Co., Ltd.
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
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
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
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.
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, Microvascular Inflammation
A Study to Learn More About the Long-Term Safety and Effects of Felzartamab Infusions in Adults With Kidney Transplants Who Have Antibody-Mediated Rejection (AMR) or Microvascular Inflammation (MVI) (TRANSCEND/TRANSPIRE LTE)
In this study, researchers will learn more about a drug called felzartamab in people who have received a kidney transplant and then developed antibody-mediated rejection (AMR) or microvascular inflammation (MVI).
- Trial name
- NCT07444489
- Testing
- Felzartamab
- Where
- 14 sites in United States
- Volunteers
- 201 people
- Sponsor
- Biogen
Transplant Rejection
BIVV020 (SAR445088) in Prevention and Treatment of Antibody-mediated Rejection (AMR)
Primary Objectives: Cohort A: To evaluate the efficacy of BIVV020 in prevention of AMR Cohort B: To evaluate the efficacy of BIVV020 in treatment of active AMR Secondary Objectives: To assess the overall efficacy of BIVV020 in…
- Trial name
- NCT05156710
- Testing
- BIVV020 (SAR445088), Intravenous immunoglobulin (IVIg), Rituximab or biosimilar
- Where
- 27 sites in United States, Canada and 5 more
- Volunteers
- 48 people
- Sponsor
- Sanofi
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
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
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
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, 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.
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.
Antibody-Mediated Rejection (AMR)
A Study of Mezagitamab in Adults With Late Antibody-Mediated Rejection (AMR) After a Kidney Transplant
Antibody-mediated rejection (AMR) is a major cause of worsening kidney function after a kidney transplant (kidney allograft dysfunction) and can lead to kidney failure.
- Trial name
- NCT07613359
- Testing
- Mezagitamab
- Where
- 35 sites in United States, China and 3 more
- Volunteers
- 36 people
- Sponsor
- Takeda
Antibody-mediated Rejection in Kidney Transplant
Assess Burden of Disease Among Kidney Transplant Recipients With Chronic Active Antibody Mediated Rejection
This study investigates the burden of disease among kidney transplant recipients that have developed Chronic Active Antibody Mediated Rejection (caAMR) compared with kidney transplant recipients that have not developed caAMR
- Trial name
- NCT05452317
- Testing
- Chronic active AMR group, Non-Chronic active AMR group
- Where
- 3 sites in United States
- Volunteers
- 52 people
- Sponsor
- CSL Behring