Clinical trials: Rejection of Renal Transplant
Kidney Transplant Rejection
A Study to Investigate the Efficacy and Safety of Frexalimab Versus Tacrolimus in Adults Undergoing Kidney Transplantation
The purpose of this open-label, randomized, active-comparator-controlled study is to determine the efficacy and safety of frexalimab subcutaneous administrations up to 5 years compared to tacrolimus capsules in adults undergoing…
- Trial name
- FREXERA (NCT07412470)
- Testing
- Frexalimab, Tacrolimus, rabbit anti-thymocyte globulin
- Where
- 73 sites in United States, Argentina and 16 more
- Volunteers
- 526 people
- Sponsor
- Sanofi
Renal Transplant Failure and Rejection
A Study Comparing Siplizumab With Rabbit Anti-Thymocyte Globulin to Help the Body Accept a Kidney Transplant
The goal of this clinical trial is to learn if siplizumab can prevent rejection of a kidney transplant in adult participants with end stage kidney disease.
- Trial name
- MODERNIZE1 (NCT07508787)
- Testing
- Siplizumab, Rabbit anti-thymocyte globulin
- Where
- 14 sites in United States, Brazil and 1 more
- Volunteers
- 120 people
- Sponsor
- Nefro Avillion Clinical Development, LLC
Kidney Transplant Rejection
Study of Tegoprubart Efficacy and Safety Compared With Tacrolimus in Kidney Transplantation
This study will evaluate the efficacy and safety of tegoprubart compared with tacrolimus in adult participants undergoing first kidney transplantation.
- Trial name
- LEGACY (NCT07835581)
- Testing
- Tegoprubart, Tacrolimus
- Volunteers
- 620 people
- Sponsor
- Eledon Pharmaceuticals
Kidney Transplant
GraftAssure Lowering Allograft rejeCTIon by Combination- (GALACTIC) Trial
The GALACTIC Registry study purpose is to validate the Combination Model-score (CM-score) for increased accuracy in the percentage of the positive predictive value (PPV) of allograft rejection results for the GraftAssure…
- Trial name
- GALACTIC (NCT07551531)
- Where
- United States
- Volunteers
- 5,000 people
- Sponsor
- Insight Molecular Diagnostics
Kidney Transplant Rejection
Safety and Efficacy of Tegoprubart in Patients Undergoing Kidney Transplantation
This study will evaluate the safety and efficacy of AT-1501 compared with tacrolimus in patients undergoing kidney transplantation.
- Trial name
- NCT05983770
- Testing
- AT-1501, Tacrolimus
- Where
- 43 sites in United States, Australia and 5 more
- Volunteers
- 127 people
- Sponsor
- Eledon Pharmaceuticals
Kidney Transplant Rejection, End Stage Renal Disease
Safety & Tolerability Study of Chimeric Antigen Receptor T-Reg Cell Therapy in Living Donor Renal Transplant Recipients
The purpose of this study is to evaluate the safety and tolerability of TX200-TR101 and its effects on the donated kidney in living donor kidney transplant recipients.
- Trial name
- STEADFAST (NCT04817774)
- Testing
- TX200-TR101
- Where
- 5 sites in Belgium, Netherlands and 1 more
- Volunteers
- 26 people
- Sponsor
- Sangamo Therapeutics
Kidney Transplant Rejection
Long-Term Safety and Efficacy of Tegoprubart in Kidney Transplant Recipients
This study will evaluate the long term safety and efficacy of AT-1501 (tegoprubart) compared with tacrolimus in patients undergoing kidney transplantation.
- Trial name
- NCT06126380
- Testing
- AT-1501, Tacrolimus
- Where
- 43 sites in United States, Australia and 6 more
- Volunteers
- 132 people
- Sponsor
- Eledon Pharmaceuticals
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 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 Transplant Rejection, Cell-free DNA
Validation of Donor-Derived Cell-Free DNA (Dd-cfDNA) for Kidney Transplant Monitoring
The goal of this observational study is to learn if the donor-derived cell-free DNA (dd-cfDNA) test can assess rejection in kidney transplant recipients. Participants will have blood and urine collected at their study visit.
- Trial name
- NCT07060716
- Testing
- donor-derived cell-free DNA test
- Where
- 10 sites in United States, Germany
- Volunteers
- 125 people
- Sponsor
- Insight Molecular Diagnostics
Immunosuppression Management, Biomarkers / Blood
PIONEER Trial (Post-Transplant Application of TruGraf and TRAC Molecular Panel in Renal Transplant Recipients)
This is an observational, prospective, multi-center trial designed to evaluate clinical outcomes in kidney transplant recipients undergoing TruGraf and TRAC monitoring. Approximately 15 U.S. sites
- Conditions
- Immunosuppression Management, Biomarkers / Blood, Subclinical Rejection, Biopsy
- Trial name
- PIONEER (NCT07231328)
- Testing
- There is no required Intervention for this Protocol. Based on Results for TruGraf/TRAC/TRAC ID Investigators may use the results in managing subjects Immunosuppression or rule out rejection.
- Volunteers
- 600 people
- Sponsor
- Transplant Genomics, Inc.
Prevention of Rejection in Kidney Transplant
Safety, Pharmacokinetics, and Efficacy of AT 1501 in Patients Undergoing Kidney Transplant
This study will evaluate the safety, PK, and efficacy of AT 1501 in patients undergoing kidney transplantation.
- Trial name
- NCT05027906
- Testing
- AT-1501
- Where
- 9 sites in United States, Australia and 3 more
- Volunteers
- 48 people
- Sponsor
- Eledon Pharmaceuticals
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
Transplant Rejection, Transplant Kidney
Study of the Plasma and Urinary cfDNA of in Kidney Transplant Patients
It has been shown that the amount of circulating donor-cell-free DNA increases in patients with transplant rejection. Quantification of single nucleotide polymorphisms (SNPs) present in circulating donor DNA currently allows for…
- Trial name
- PLAKID-TRANSP (NCT06910527)
- Where
- France
- Volunteers
- 250 people
- Sponsor
- Poulet Geoffroy
Kidney Transplant Failure and Rejection
A Follow up Study of Patients Treated With Imlifidase Prior to Kidney Transplantation
The rationale for the current protocol is to collect data from extended follow up in subjects that have received a kidney transplant following imlifidase dosing to provide a better understanding regarding the long-term outcome…
- Trial name
- NCT03611621
- Testing
- Imlifidase
- Where
- 6 sites in United States, France and 1 more
- Volunteers
- 31 people
- Sponsor
- Hansa Biopharma AB
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 Diseases, Kidney Disease, Chronic
Clinical Impact of the IBox As an Early Intervention TooL
International, multicentre, randomized 1:1 controlled trial to prove the clinical and medico economic benefits of the medical device Predigraft, by showing that the use of Predigraft could improve patient's follow-up.
- Conditions
- Kidney Diseases, Kidney Disease, Chronic, Kidney Transplant Rejection, Kidney Transplant; Complications
- Trial name
- NCT05112315
- Testing
- Predigraft
- Where
- 16 sites in Austria, France and 4 more
- Volunteers
- 507 people
- Sponsor
- Predict4Health
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.
Kidney Transplant Failure and Rejection
BIOtechnology Applied to Renal TRansplantation With IMmunobiogram
Immunobiogram (IMBG) is a novel in vitro diagnostic bioassay developed by Biohope Scientific Solutions for Human Health SL, that allows to measure the pharmacodynamic response to individual immunosuppressive drugs in patients…
- Trial name
- BIOTRAIM (NCT05816486)
- Testing
- Immunobiogram
- Where
- 15 sites in Brazil, France and 3 more
- Volunteers
- 443 people
- Sponsor
- Biohope Scientific Solutions for Human Health, S.L.
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.