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
Kidney Transplantation
Safety & Tolerability of Berinert® (C1 Inhibitor) Therapy to Prevent Rejection
Organ transplantation offers the only hope for a normal life for patients with end-stage renal disease on dialysis (ESRD). For the highly-sensitized patient, patients with antibodies to human leukocyte antigens (HLA)…
- Trial name
- NCT01134510
- Testing
- C1 Esterase Inhibitor
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Stanley Jordan, MD
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
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
Kidney Transplant
Dosing Regimen of Eculizumab Added to Conventional Treatment in Positive Cross Match Living Donor Kidney Transplant
A strongly positive crossmatch has long been considered an absolute contraindication to kidney transplantation and most patients with anti-human leukocyte antigen (HLA) antibody never were able to receive a kidney transplant.
- Trial name
- NCT00670774
- Testing
- Eculizumab
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- Mark Stegall
Lung Transplant Rejection
Combination Therapy With Carfilzomib for the Antibody-Mediated Rejection Diagnosis in Lung Transplantation
The clinical trial is a Phase II open label, single-arm pilot study to evaluate the safety and efficacy of combination therapy with carfilzomib, plasma exchange and intravenous immunoglobulins for AMR after lung transplantation…
- Trial name
- NCT02474927
- Testing
- Carfilzomib
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- John F. McDyer, MD
Renal Disease
Ides in Highly Sensitized (HS) Patients Awaiting Kidney Transplantation
This is a single center phase I/II open label, exploratory study assessing safety and efficacy of IdeS® (Hansa Medical, Lund, Sweden) given immediately prior to kidney transplantation.
- Trial name
- NCT02426684
- Testing
- IdeS® (Imlifidase)
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Cedars-Sinai Medical Center
Antibody Mediated Rejection of Kidney Transplant
C1-Inhibitor (INH) for Refractory Antibody Mediated Renal Allograft Rejection
This is an open-label, single arm trial in which patient who have ongoing antibody mediated rejection of a kidney transplant deemed refractory to maximal medical therapy are given the complement inhibitor C1-INH (Berinert) in an…
- Trial name
- NCT02936479
- Testing
- C1-INH (Berinert)
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- NYU Langone Health
Graft Rejection
Randomized Trial for Mixed Acute Rejection
This study is being conducted to determine how safe and effective using an immune cell (b cell) depleting therapy and/or Thymoglobulin is in patients with a kidney transplant who are experiencing certain types of rejection.
- Trial name
- NCT00771875
- Testing
- Rabbit Antithymocyte Globulin (RATG), Rituximab, Bortezomib
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- University of Cincinnati
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
Antibody-mediated Rejection, Hyperacute Rejection of Cardiac Transplant
The De-novo Use of Eculizumab in Presensitized Patients Receiving Cardiac Transplantation
All individuals who receive a heart transplant are at risk for developing antibody-mediated rejection (AMR). An antibody is a protein produced by the body's immune system when it detects a foreign substance, called an antigen.
- Conditions
- Antibody-mediated Rejection, Hyperacute Rejection of Cardiac Transplant, Left Ventricular Dysfunction, Cardiac Allograft Vasculopathy
- Trial name
- DUET (NCT02013037)
- Testing
- Eculizumab
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Cedars-Sinai Medical Center
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 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
Transplant Glomerulopathy
Treatment of Chronic Antibody-mediated Rejection in Kidney Transplant With Acthar
This is an open label safety and feasibility trial using Acthar® in addition to the investigators center-specific standard therapy, which could include increase in maintenance immunosuppression, high dose IVIG (intravenous…
- Trial name
- TGActhar (NCT02546492)
- Testing
- Acthar gel
- Where
- 2 sites in United States
- Volunteers
- 6 people
- Sponsor
- University of Maryland, Baltimore
Kidney Failure, Chronic
Induction Therapy Study in Live Donor Kidney Transplant Recipients With a Positive Crossmatch
The purpose of this study is to determine whether the anti-T cell antibody, Thymoglobulin is a more effective induction medication than the anti-IL-2R inhibitor daclizumab, in kidney transplant recipients who have a positive…
- Trial name
- NCT00275509
- Testing
- Thymoglobulin, Daclizumab, Plasmapheresis
- Where
- United States
- Volunteers
- 56 people
- Sponsor
- Johns Hopkins University