Clinical trials: Kidney Graft Rejection
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
Kidney Transplant Rejection
Evaluation of Patient Outcomes From the Kidney Allograft Outcomes AlloSure Registry
This is an observational study to evaluate safety and efficacy outcomes in renal transplant recipients in whom post-transplant care is managed using AlloSure®.
- Trial name
- KOAR (NCT03326076)
- Testing
- Donor-derived cell-free DNA (AlloSure®), Standard care, Peripheral blood gene expression profiling (AlloMap Kidney)
- Where
- 72 sites in United States
- Volunteers
- 4,000 people, healthy volunteers welcome
- Sponsor
- CareDx
Graft Rejection, Kidney Transplantation
Study Comparing the Safety and Efficacy of Belatacept With That of Cyclosporine in Patients With a Transplanted Kidney
The purpose of this study is to determine whether treatment with Belatacept (BMS-224818) is as efficacious as treatment with cyclosporine at preventing acute rejection and with a superior safety/tolerability profile (better…
- Conditions
- Graft Rejection, Kidney Transplantation, Renal Transplantation
- Trial name
- NCT00035555
- Testing
- Belatacept, Cyclosporine, Mycophenolate mofetil (MMF)
- Where
- 12 sites in United States
- Volunteers
- 230 people
- Sponsor
- Bristol-Myers Squibb
Kidney Transplantation
Benefit of Early Protocol Biopsy and Treatment of Subclinical Rejection
This multicentre randomized, controlled trial (RCT) compared renal allograft histology and function in subjects treated with Tacrolimus + MMF + prednisone undergoing early protocol biopsies and treatment of subclinical rejection…
- Trial name
- NCT00885820
- Testing
- Tacrolimus, MMF, Corticosteroids (Prednisone)
- Where
- 12 sites in United States, Canada
- Volunteers
- 240 people
- Sponsor
- Astellas Pharma Inc
Kidney Transplant Rejection
SRDK0921_ Analytical Performance Study
Analytical Performance Study of the SRDK0921 IVD medical device (Kit and Software)
- Trial name
- SRDK0921_APS (NCT05747274)
- Testing
- SRDK0921
- Where
- France
- Volunteers
- 439 people
- Sponsor
- BioMAdvanced Diagnostics
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
Microvascular Inflammation
A Study to Learn About the Effects of Felzartamab Infusions in Adults With Kidney Transplants Who Have Late Isolated Microvascular Inflammation
In this study, researchers will learn more about a drug called felzartamab in people who have received a kidney transplant and later developed a condition called microvascular inflammation (MVI).
- Trial name
- TRANSPIRE (NCT07219043)
- Testing
- Felzartamab
- Where
- 51 sites in United States, Argentina and 9 more
- Volunteers
- 81 people
- Sponsor
- Biogen
Kidney Transplant Rejection, End Stage Renal Disease
Long-Term Follow-Up of TX200-TR101 (STEADFAST Long Term)
This long-term follow-up study is being conducted to collect long-term (up to 15 years post-infusion) safety and tolerability data from subjects enrolled in studies evaluating TX200-TR101.
- Trial name
- NCT05987527
- Testing
- Blood sample
- Where
- 5 sites in Belgium, Netherlands and 1 more
- Volunteers
- 11 people
- Sponsor
- Sangamo Therapeutics
Kidney Transplantation, Renal Transplantation
A Study to Evaluate FK778 in Kidney Transplant Patients
A dose finding study to evaluate the safety and effectiveness of FK778 in kidney transplant patients
- Conditions
- Kidney Transplantation, Renal Transplantation, Transplantation, Renal, Transplantation, Kidney
- Trial name
- NCT00189735
- Testing
- FK778
- Where
- 37 sites in Austria, Belgium and 10 more
- Volunteers
- 364 people
- Sponsor
- Astellas Pharma Inc
Graft Rejection
Safety/Efficacy of Everolimus and Neoral® in Adult Cardiac Transplant Patients With Established Allograft Vasculopathy
Everolimus is an immunosuppressive drug that is being studied for preventing acute rejection that can happen after heart transplantation. It is usually used in combination with other immunosuppressive drugs such as cyclosporine.
- Trial name
- NCT00097968
- Testing
- everolimus
- Where
- 6 sites in United States
- Sponsor
- Novartis Pharmaceuticals
Kidney Transplant Rejection
Acceptability and Feasibility of TruGraf® Testing as Part of the Standard of Care
This is an observational study in renal transplant recipients to evaluate the acceptability, feasibility, and clinical utility of TruGraf® testing in conjunction with standard clinical assessment.
- Trial name
- NCT04267016
- Testing
- TruGraf Testing - Peripheral blood gene expression profiling
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- Transplant Genomics, Inc.
Kidney Transplant Rejection
Cellular Immunotherapy in Recipients of HLA-matched, Living Donor Kidney Transplants
The primary objective of this study is to demonstrate the safety and efficacy of cellular immunotherapy with MDR-101 for induction of functional immune tolerance in recipients of human leukocyte antigen (HLA)-matched, living…
- Trial name
- NCT03363945
- Testing
- MDR-101
- Where
- 19 sites in United States, Canada
- Volunteers
- 30 people
- Sponsor
- Medeor Therapeutics, Inc.
Kidney Transplant Rejection
Validation of Genomic Immune-phenotyping Profiles to Predict Risk of Kidney Transplant Rejection
Global, non-randomized, observational study for the validation of Verici Dx genomic tests to predict risk of kidney clinical and subclinical acute rejection, and chronic allograft damage or interstitial fibrosis / tubular atrophy…
- Trial name
- NCT04727788
- Where
- 13 sites in United States, France and 2 more
- Volunteers
- 550 people
- Sponsor
- Verici Dx
Kidney Transplantation
REgulatory T Cell Therapy to Achieve Immunosuppression REduction
The goal of this multi-national, multi-center, open-label, randomized Phase 2 trial is to determine the safety and efficacy of administering expanded regulatory T cells (TRK-001) to prevent allograft rejection in living donor…
- Trial name
- RETIRE (NCT06552169)
- Testing
- Arm 1: SOC (mTOR + CNI), Arm 2A: TRACT/MONO mTOR, Arm 2B: TRACT/MONO CNI
- Where
- 7 sites in United States, Taiwan
- Volunteers
- 34 people
- Sponsor
- Singulera Therapeutics Inc.
Prevention of Acute Rejection in Paediatric Recipients of a Renal Transplant
Efficacy, Tolerability and Safety of Early Introduction of Everolimus, Reduced Calcineurin Inhibitors and Early Steroid Elimination Compared to Standard CNI, Mycophenolate Mofetil and Steroid Regimen in Paediatric Renal Transplant Recipients
The purpose of this study is to determine if everolimus combined with reduced exposure CNI (TAC) is efficacious and safe and will support corticosteroid elimination compared to a standard exposure CNI (TAC) + MMF + steroid…
- Trial name
- NCT01544491
- Testing
- RAD001, MMF
- Where
- 31 sites in United States, Argentina and 11 more
- Volunteers
- 106 people
- Sponsor
- Novartis Pharmaceuticals
Acute Renal Transplant Rejection
NI-0401 in Patients With Acute Renal Allograft Rejection
The purpose of the study is to determine the safety and tolerability of NI-0401 and whether NI-0401 can reverse BpACR.
- Trial name
- NCT00805909
- Testing
- NI-0401
- Where
- France
- Volunteers
- 12 people
- Sponsor
- Light Chain Bioscience - Novimmune SA
Cadaveric Donor Renal Transplantation, Acute Renal Allograft Rejection
An Open-label, Prospective, Randomized, Multi-center, Phase II Comparative Trial of Thymoglobulin Versus Simulect for the Prevention of Delayed Graft Function and Acute Allograft Rejection in Renal Allograft Recipients.
A multicenter clinical study comparing event-free survival at 6 months after transplant between Thymoglobulin-treated and Simulect-treated adult kidney transplant patients.
- Conditions
- Cadaveric Donor Renal Transplantation, Acute Renal Allograft Rejection, Induction Therapy
- Trial name
- NCT00235300
- Testing
- Thymoglobulin [Anti-thymocyte Globulin (rabbit)], Simulect (basliximab)
- Where
- 28 sites in United States, France and 3 more
- Volunteers
- 240 people
- Sponsor
- Genzyme, a Sanofi Company
Kidney Transplant
First in Human Study: LIS1, an Induction Treatment in Kidney Transplanted Patients
This first in human study aims at evaluating LIS1, a stabilized solution of purified anti-T lymphocytes polyclonal glyco-humanized swine IgG with immunosuppressive activity, in regards of safety, T cell depletion, and…
- Trial name
- NCT04431219
- Testing
- LIS1
- Where
- Czechia
- Volunteers
- 10 people
- Sponsor
- Xenothera SAS
Kidney Transplant Rejection
The PROspera Kidney Transplant ACTIVE Rejection Assessment Registry (ProActive)
The ProActive registry is a longitudinal, multi-center study with a prospective arm observing clinical care for patients receiving physician ordered Prospera, an allograft rejection test, and a historical control arm collecting…
- Trial name
- ProActive (NCT04091984)
- Testing
- Prospera
- Where
- 55 sites in United States
- Volunteers
- 5,000 people
- Sponsor
- Natera, Inc.
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.