Clinical trials: Transplant Rejection
Rejection Acute Renal, Rejection Chronic Renal
Extended Validation of Donor-derived Cell-free DNA in Kidney Transplant Recipients
This is a multinational, multi-center, observational cohort study. Kidney allograft rejection is poorly detected by standard-of-care biomarkers.
- Conditions
- Rejection Acute Renal, Rejection Chronic Renal, Transplantation, Kidney Rejection Transplant
- Trial name
- VALiDATE (NCT07805343)
- Testing
- Donor-derived cell-free DNA
- Where
- 25 sites in United States, Belgium and 6 more
- Volunteers
- 5,000 people
- Sponsor
- Paris Translational Research Center for Organ Transplantation
Heart Transplant Rejection
Surveillance HeartCare® Outcomes Registry
This is an observational registry to assess the clinical utility of surveillance using HeartCare testing services, in association with clinical care of heart transplant recipients.
- Trial name
- SHORE (NCT03695601)
- Testing
- Standard of Care
- Where
- 67 sites in United States
- Volunteers
- 2,743 people
- Sponsor
- CareDx
Kidney Transplant Rejection, Kidney Transplant Failure
The smartNTx Trial:Telemedical Management Versus Standard Aftercare in Kidney Transplant Recipients (KTR)
The smartNTx trial: Prospective, randomized controlled trial (RCT) to investigate additional interventional telemedical management versus standard aftercare in kidney transplant recipients (KTR).
- Trial name
- smartNTx (NCT05897047)
- Testing
- Additional interventional telemedical management
- Where
- 2 sites in Germany
- Volunteers
- 391 people
- Sponsor
- University of Erlangen-Nürnberg Medical School
Rejection; Transplant, Kidney, Rejection; Transplant, Pancreas
A Multicenter Randomized Controlled Trial to Treat Acute T Cell Mediated Rejection in Kidney and Kidney-Pancreas Transplant Recipients
After a kidney or a kidney-pancreas transplant, some patients may face problems with their new organs. This happens because the body sometimes makes a mistake and tries to get rid of the organ. This problem is called rejection.
- Trial name
- TACKLE-IT (NCT06474273)
- Testing
- Methylprednisolone, Prednisone
- Where
- 30 sites in Australia, Canada and 1 more
- Volunteers
- 540 people
- Sponsor
- University of Sydney
Antibody Mediated Rejection of Lung Transplant
A Phase 1 Clinical Trial of Siltuximab for the Treatment of Antibody-Mediated Rejection After Lung Transplantation
Antibody-mediated rejection after lung transplantation commonly results in allograft failure and death in spite of current therapeutic regimens.
- Trial name
- Siltux-AMR (NCT06990711)
- Testing
- Siltuximab
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- Washington University School of Medicine
Acute Rejection of Renal Transplant, Graft Failure
Dd-cfDNA and Treg in Prediction of Kidney Transplant Acute Rejection
Acute rejection after kidney transplantation should ideally be diagnosed prior to immunologic injury in a non-invasive fashion in order to improve long-term graft function.
- Trial name
- NCT05084768
- Testing
- Donor-derived cell-free DNA
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- Loma Linda University
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
Heart Transplant, Pediatric Heart Transplant
Non-invasive Prediction of EArly Cardiac rEjection
Acute rejection remains a major cause of morbidity and mortality in pediatric patients after heart transplant. In order to screen for rejection, most centers perform heart catheterizations with endomyocardial biopsies frequently…
- Conditions
- Heart Transplant, Pediatric Heart Transplant, Rejection, Cardiac MRI
- Trial name
- PEACE (NCT07770659)
- Where
- 22 sites in United States
- Volunteers
- 200 people
- Sponsor
- Vanderbilt University Medical Center
Kidney Transplant, Kidney Transplant Failure and Rejection
(TNX-1500) in Kidney Transplant Recipients
The primary objective is to investigate the safety of TNX-1500, an FC-modified anti-CD154 mAb, in five kidney transplant recipients at 12 months.
- Conditions
- Kidney Transplant, Kidney Transplant Failure and Rejection, Immunosuppression, Immunosuppression After Kidney Transplantation
- Trial name
- TONIX-1500 (NCT07204080)
- Testing
- TNX-1500, Kidney Transplant
- Where
- 2 sites in United States
- Volunteers
- 5 people
- Sponsor
- Ayman Al Jurdi, MD
Transplant
Immune Function as Predictor of Infectious Complications and Clinical Outcome in Patients Undergoing Solid Organ Transplantation
At Rigshospitalet, Denmark, we will examine the immune function of solid organ transplant recipients before and at several timepoints after transplantation as well as the clinical outcome, especially the risk of infections…
- Trial name
- Immune-Mo (NCT03847285)
- Testing
- solid organ transplantation
- Where
- Denmark
- Volunteers
- 188 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Kidney Transplant, Rejection
Detection of Circulating Kidney DNA in Kidney Transplant Patients Facing an Episode of Graft Rejection
In France, 3,500 kidney transplants are carried out per year; and 40,000 people succeed in 2019 with a kidney transplant. Despite regular medical monitoring, nearly 30% of transplant patients will develop rejection.
- Trial name
- DART-RREGREF (NCT06351488)
- Where
- 3 sites in France
- Volunteers
- 319 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Kidney Transplant Failure and Rejection, Kidney Transplant; Complications
ECP-DL Cell Infusion for Induction in Living Donor Kidney (LDK) Transplants
This is a phase 1 trial, 36 month duration for subjects with end-stage renal disease (ESRD). The objectives of the trail are1) Determine the safety of ECP-DL cell infusion in living donor renal transplant recipients.
- Trial name
- ECP (NCT07083830)
- Testing
- ECP-DL treated mononuclear cell infusion
- Volunteers
- 24 people
- Sponsor
- Northwestern University
Kidney Transplant Rejection, Kidney Transplant
Microbiome and Immunosuppression: The Mission Study
The purpose of this research is to study immunosuppression drugs, certain foods, and how they can change the microbiome (the natural microorganisms inside the body) of the individual taking the immunosuppressive medications.
- Trial name
- MISSION (NCT04953715)
- Testing
- collection of body microbiome
- Where
- 2 sites in United States
- Volunteers
- 140 people
- Sponsor
- The University of Texas Medical Branch, Galveston
Lung Transplant; Complications, Lung Transplant; Infection or Inflammation
Prospective Multicenter Research on Donor and Recipient Management Strategies to Improve Lung Transplant Outcomes
This project aims to collect detailed clinical data, blood samples, and patient-reported outcomes from 2,600 lung transplant candidates, donors, and recipients at Lung Transplant Centers.
- Conditions
- Lung Transplant; Complications, Lung Transplant; Infection or Inflammation, Lung Transplant Rejection, Lung Transplant Failure
- Trial name
- PROMISE (NCT06399302)
- Where
- 19 sites in United States, Canada
- Volunteers
- 2,600 people
- Sponsor
- Duke University
Heart Transplant Failure and Rejection
Precision Guided Tacrolimus Dosing in Pediatric Heart Transplant
Immunosuppressive therapy is required to prevent organ rejection, however, dosing of immunosuppressive agents is complicated by patient-specific differences impacting the body's absorption and elimination of these agents.
- Trial name
- NCT04380311
- Testing
- Tacrolimus Dosing Support Tool
- Where
- 2 sites in United States
- Volunteers
- 17 people
- Sponsor
- University of Utah
Kidney Transplant Rejection
Impact of the Microbiota on the Likelihood of Renal Graft Rejection
Identification of a bacterial signature in the blood or stool that may be associated with acute rejection in patients treated with Nulojix during their first year of transplant.
- Trial name
- MERRLIN (NCT04736381)
- Testing
- Belatacept Injection [Nulojix]
- Where
- 10 sites in France
- Volunteers
- 70 people
- Sponsor
- Institut National de la Santé Et de la Recherche Médicale, France
Pediatric Heart Transplantation, Immunosuppression
Tacrolimus/Everolimus vs. Tacrolimus/MMF in Pediatric Heart Transplant Recipients Using the MATE Score
The TEAMMATE Trial will enroll 210 pediatric heart transplant patients from 25 centers at 6 months post-transplant and follow each patient for 2.5 years.
- Conditions
- Pediatric Heart Transplantation, Immunosuppression, Chronic Kidney Diseases, Cardiac Allograft Vasculopathy
- Trial name
- TEAMMATE (NCT03386539)
- Testing
- Everolimus, Tacrolimus, Mycophenolate Mofetil
- Where
- 25 sites in United States
- Volunteers
- 211 people
- Sponsor
- Boston Children's Hospital
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
Lung Transplant, End Stage Lung Disease
GRAfT 2.0. A Multimodal Prospective Approach to Define the Mechanisms and Clinical Features of Acute and Chronic Rejection in Lung Transplantation
Background: Lung transplants can save lives, but the procedure has risks. Some people develop donor-specific antibodies (DSA) after the procedure-that is, their bodies create proteins that treat the new lungs as foreign and mount…
- Conditions
- Lung Transplant, End Stage Lung Disease, Rejection
- Trial name
- NCT07516379
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)