Clinical trials: Transplant Rejection
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.
Bronchiolitis Obliterans, Chronic Rejection of Lung Transplant
Efficacy + Safety of Liposome Cyclosporine A to Treat Bronchiolitis Obliterans Post Single Lung Transplant (BOSTON-1)
The objective of this trial is to assess the efficacy and safety of aerosolized liposomal cyclosporine A (L-CsA) as add-on therapy to standard of care (SoC) as compared to SoC alone in single lung transplant recipients with…
- Conditions
- Bronchiolitis Obliterans, Chronic Rejection of Lung Transplant, Lung Transplant Rejection, Lung Transplant; Complications
- Trial name
- BOSTON-1 (NCT03657342)
- Testing
- Liposomal Cyclosporine A, standard of care
- Where
- 39 sites in United States, Belgium and 5 more
- Volunteers
- 62 people
- Sponsor
- Zambon SpA
Lung Transplant Rejection
Assessment of Chronic Lung Allograft Dysfunction Using Single-breath & Multi-breath Hyperpolarized Xenon-129 MRI
This study will use Magnetic Resonance Imaging (MRI) to study the lungs of 90 volunteers using the inhaled contrast agent, hyperpolarized xenon-129.
- Trial name
- NCT04941573
- Testing
- Hyperpolarized 129-Xenon (MagniXene) MRI of the lung
- Where
- United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Xemed LLC
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
Lung Transplant Rejection
Analysis of Volatile Organic Compounds in the Breath of Lung Transplant Rejection Patients Using Infrared Spectroscopy
This study will sample and analyze volatile organic compounds (VOCs) from participants considered to be at risk for developing rejection following lung transplant by using infrared spectroscopy.
- Trial name
- NCT06309628
- Testing
- Breathe sample
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- Paragonix Technologies
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
Lung Transplant Rejection
LAMBDA 002 (Lung Registry) Study
The LAMBDA 002 registry study is an observational, longitudinal, multi-center study observing patients undergoing lung transplant.
- Trial name
- NCT05170425
- Testing
- Prospera
- Where
- 11 sites in United States
- Volunteers
- 154 people
- Sponsor
- Natera, Inc.
Heart Transplant Rejection
Prospera Test Evaluation in Cardiac Transplant (ProTECT)
The ProTECT registry is an observational longitudinal, multi-center study observing patients undergoing heart transplant for whom Prospera testing is part of routine clinical care, who are enrolled within 60 days of heart…
- Trial name
- ProTECT (NCT05205551)
- Where
- United States
- Volunteers
- 411 people
- Sponsor
- Natera, Inc.
Liver Transplant Rejection
Study of Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibody, CFZ533, in Liver Transplant Recipients With Additional 12-month Follow-up and Long-term Extension
This was a multicenter, open-label, active-controlled study to evaluate the efficacy, safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of two CFZ533 maintenance doses in de novo liver transplant recipients.
- Trial name
- CONTRAIL I (NCT03781414)
- Testing
- CFZ533, Tacrolimus - MMF - corticosteroids
- Where
- 29 sites in United States, Argentina and 8 more
- Volunteers
- 129 people
- Sponsor
- Novartis Pharmaceuticals
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
Transplant Rejection, Allograft Rejection
Study for the Prediction of Active Rejection in Organs Using Donor-derived Cell-free DNA Detection
This is a multi-center prospective study designed to collect blood samples from transplant patients in order to improve Natera's method for determining allograft rejection status using the donor-derived cell-free DNA analysis…
- Conditions
- Transplant Rejection, Allograft Rejection, Complications
- Trial name
- SPARO (NCT03984747)
- Where
- 4 sites in United States
- Volunteers
- 110 people
- Sponsor
- Natera, Inc.
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
Lung Transplant Rejection
An Open Label Trial Evaluating the Safety, Tolerability, Efficacy and Pharmacokinetic Profile of Tacrolimus Inhalation Powder in Adult Lung Transplant Recipients
Part A: This is an open label, single-arm study that will evaluate the safety, tolerability, efficacy and PK of Tacrolimus Inhalation Powder over 12 weeks in lung transplant patients who require reduced blood levels of tacrolimus…
- Trial name
- NCT05501574
- Testing
- Tacrolimus Inhalation Powder, Plastiape RS00 Dry Powder inhaler device
- Where
- 2 sites in Australia
- Volunteers
- 14 people
- Sponsor
- TFF Pharmaceuticals, Inc.
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
Cardiac Transplant Failure, Cardiac Transplant Rejection
Utility of Donor-Derived Cell Free DNA in Association With Gene Expression Profiling
Plasma donor-derived cell-free DNA (dd-cfDNA) is measured as a % of the total plasma cfDNA in association with the measurement of AlloMap, a non-invasive gene expression test to aid in heart transplant management.
- Conditions
- Cardiac Transplant Failure, Cardiac Transplant Rejection, Heart Diseases
- Trial name
- D-OAR (NCT02178943)
- Where
- 28 sites in United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- CareDx
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.
Solid Organ Transplant Rejection, Organ Rejection Transplants
Expanded Access for Use of ExoFlo in Abdominal Solid Organ Transplant Patients
This Expanded Access Protocol will provide access to the IMP ExoFlo for patients who have severe or life-threatening abdominal solid organ transplant rejection or who are evaluated and determined to be at high risk of progression…
- Conditions
- Solid Organ Transplant Rejection, Organ Rejection Transplants, Organ Rejection
- Trial name
- NCT05215288
- Testing
- ExoFlo
- Where
- 2 sites in United States
- Sponsor
- Direct Biologics, LLC
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.