Clinical Trials

The purpose of this study is to decrease the waiting time on the transplant list for patients who have high level of anti-HLA antibodies with ESRD and improve the patients and allograft survival after transplant.

The purpose of this study is to test the tolerability, safety, and effectiveness of 12 weeks once-daily fenofibrate in reducing Ischemic Cholangiopathy (IC) incidence after Donation after Circulatory Death (DCD) liver transplantation. Additionally to assess the association between serum markers of cholestasis and development of IC. Tolerability and safety will be assessed as proportions of: drug discontinuation, and new grade 3 or 4 adverse events. Effectiveness will be assessed as incidence of cholangiographically-diagnosed IC and incidence of any IC-related complication.

The main focus of this study is to develop blood and/or urine tests that will help to detect early signs of rejection in people who have had a liver transplant. Researchers will examine blood, urine, and tissue samples and try to identify markers for certain conditions such as rejection, response to therapy, and scarring of the liver. Additionally, researchers would like to identify biomarkers that can detect damage to the native kidneys before blood levels of creatinine rises. By studying gene expression, researchers hope to be able to diagnose these conditions earlier and improve liver survival.

To evaluate the efficacy of Cinryze® given for the treatment of acute antibody-mediated rejection (of renal allograft) (AMR) in kidney transplant recipients as measured by the proportion of subjects with new or worsening transplant glomerulopathy (TG) at 6 months after treatment initiation.

The purpose of this study is to validate the use of an RNA-seq based peripheral blood assay in renal transplant recipients in adult kidney transplant recipients.  

The purpose of this study is to validate an MRI method to detect renal fibrosis in patients after kidney transplantation (KT).

The purpose of this study is to attempt to improve outcomes after kidney transplantation and to improve the safety of living kidney donation based upon variation in the apolipoprotein L1 gene (APOL1). Genes control what is inherited from a family, such as eye color or blood type. Variation in APOL1 can cause kidney disease. African Americans, Afro-Caribbeans, Hispanic Blacks, and Africans are more likely to have the APOL1 gene variants that cause kidney disease. APOLLO will test DNA from kidney donors and recipients of kidney transplants for APOL1 to determine effects on kidney transplant-related outcomes.

The purpose of this retrospective and prospective study is to evaluate tissue bank from donors and recipients who underwent heart and lung transplant in order to study the Role of Mitochondrial DNA in Encoding Histocompatibility Antigens in humans and rejection.

The purpose of this study is to determine the incidence of biopsy proven acute rejections detected due to elevated dd-cfDNA independent of change in serum creatinine, to determine incidence of DeNovo Donor specific antibody (DSA) or increase in preexisting DSA’s in presence of elevated dd-cfDNA, and to determine the association of elevated dd-cfDNA with progression of chronic changes in surveillance biopsies.

The objectives of this study is to evaluate the efficacy of Daratumumab as an HLA desensitization strategy prior to cardiac transplantation in highly-sensitized patients.

The purpose of this study is to evaluate genes collected comparing a recipient's serum, a recipient's original liver and the donor liver graft to determine the characteristics of livers that are susceptible versus resistant to recurrent disease, to reduce the likelihood of liver graft failure in the long-term.

The purpose of this trial is to evaluate the reduction in incidence and severity of delayed graft function when using QPI-1002 with kidney transplants from donors older than 45 years who have brain death.

The purposes of this study are to prospectively evaluate the effects of a structured, modified Mediterranean diet on post-liver transplant weight gain and development of PTMS, to prospectively evaluate the effects of a structured, modified Mediterranean diet on cardiovascular outcomes post-liver transplantation, and to prospectively evaluate the effects of a structured, modified Mediterranean diet on development or recurrence or de novo NAFLD/NASH in liver-transplant patients.

The purpose of this study is to determine if “booster” revaccination with the Janssen Ad26.CoV2.S vaccine (JNJ-78436735, aka the J&J vaccine, a viral vector vaccine) increases anti-COVID spike protein antibody levels in solid organ transplant recipients who did not form acceptable levels of anti-COVID spike protein antibody after receiving two doses of a mRNA vaccine: Pfizer-BioNTech (BNT162b2 vaccine) or Modena (mRNA-1273). 

The purpose of this study is to explore adherence, barriers, side effects, and preference for pharmacologic antifungal prophylaxis following lung transplant. 

The purpose of this study to collect blood samples and data to assess the diagnostic capability of an updated version of the Prospera™ test.  The current standard of care for detection of rejection in renal allograft recipients is serum creatinine, often used in combination with other blood tests such as proteinuria. Natera has developed an assay called Prospera™ to detect the amount of donor-derived cell-free DNA (dd-cfDNA), which is a marker of kidney rejection.

Hypothesis: we hypothesize that the abundance and functions of Breg subsets in kidney transplant patients could be associated with transplant tolerance and rejection, including DSA-mediated kidney transplant rejection. In addition, oral corticosteroid treatment significantly alters the frequency and function of Breg subsets, which could lead altered clinical outcomes.

Aims, purpose, or objectives:
1. Investigate the frequency Bregs and their ability to express IL-10 along with other immune cells in the context of tolerance/rejection in kidney transplant patients.
we hypothesize that the abundance and functions of Breg subsets in kidney transplant patients could be associated with transplant tolerance and rejection, ...

A normal lung ultrasound artifact pattern in an aymptomatic lung transplant recipient with normal chest radiograph and spirometry can safely exclude significant acute cellular rejection.

The purpose of this study is to validate the use of a RNAseq-based peripheral blood assay in liver transplant recipients when correlated to liver biopsy results.

The purpose of this study is to investigate whether clazakizumab (an anti-interleukin (IL)-6 monoclonal antibody (mAb)) may be beneficial for the treatment of CABMR in recipients of a kidney transplant by inhibiting the production of Donor Specific Antibodies (DSA) and re-shaping T cell alloimmune responses.

The purpose of this study is to determine if DNA originating from the transplanted heart or lung can be detected in the blood and used to monitor for rejection.

This study aims to understand the pharmacogenomics of Native American patients compared to Caucasians who are undergoing kidney transplant for treatment of kidney disease.

The purpose of this study is to investigate ghrelin, a peptide that mechanistically carries the promise of therapeutics benefit for diverse aspects of morbidity associated with lung transplantation.

The purpose of this study is to longitudinally follow Torque Teno Virus (TTV) levels in lung transplant recipients and attempt to find a correlation with infection or rejection events.

The purpose of this study is to determine whether off-pump bilateral orthotopic lung transplantation (BOLT) or venoarterial extracorporeal membrane oxygenation (VA ECMO) lung transplantation results in higher PGD grade 3 at 48-72 hours, mortality at 90 days, and the combination of these two endpoints.

Secondly, to determine whether off-pump or VA ECMO lung transplantation has more red blood cell transfusion (intraoperative plus the first 24 hours in the ICU), chest tube output the first 24 hours, incidence of re-exploration for bleeding, air emboli, stroke, PGD grade 3 at T0 and T24, pneumonia, need for dialysis, rejection, bronchial dehiscence, tracheostomy, length of ...

The purpose of this study is to evaluate the pharmacokinetics (PK), safety and tolerability of pegcetacoplan in patients with TA-TMA.

The primary purpose of this study is to evaluate the feasibility of analysis of RNA transcripts from EVs sampled from the coronary sinus.

A Multicenter, Prospective, Double-Blind, Randomized, Placebo-Controlled, Phase 3 Study of ANG-3777 (formerly BB3) to Improve Graft Function and Reduce the Severity of Kidney Dysfunction or Delayed Graft Function Following Kidney Transplantation in Recipients of a Deceased Donor Kidney

The purpose of this study is 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 an active antibody mediated rejection (AMR) after recently been kidney transplanted. The purpose is also to investigate and compare safety for these two treatments. 20 patients will be treated with imlifidase and 10 with PE.

The purpose of this study is to attempt to improve outcomes after kidney transplantation and to improve the safety of living kidney donation based upon variation in the apolipoprotein L1 gene (APOL1). Genes control what is inherited from a family, such as eye color or blood type. Variation in APOL1 can cause kidney disease. African Americans, Afro-Caribbeans, Hispanic Blacks, and Africans are more likely to have the APOL1 gene variants that cause kidney disease. APOLLO will test DNA from kidney donors and recipients of kidney transplants for APOL1 to determine effects on kidney transplant-related outcomes.

The purpose of this study is to develop a digital droplet PCR-based method to quantitate ccfDNA., and to establish ranges of donor ccfDNA that correspond to rejection status.

The purpose of this study is to develop an RNA-seq based peripheral blood assay predictive of inflammation/rejection on allograft biopsy in adult heart transplant recipients.

This study will evaluate the safety of intramuscular administration of PLX-R18 (allogenetic ex-vivo explanded placental adherent stromal cells) in subjects who have with incomplete hematopoietic recovery after hematopoietic stem cell transplantation.

The purpose of this study is to to determine if Cardiopulmonary Bypass (CPB) is an independent risk factor for development of Primary Graft Dysfunction (PGD) as compared to Extracorporeal Membrane Oxygenation (ECMO) even when adjusted for all other recipient, donor, biologic and operative risk factors.

The purpose of this study is to evaluate safety and efficacy outcomes in renal transplant recipients in whom post-transplant care is managed using AlloSure®. AlloSure® is a non-invasive test to measure donor-derived cell-free DNA (dd-cfDNA). The AlloSure test is intended to assess the probability of allograft rejection in kidney transplant recipients with clinical suspicion of rejection and to inform clinical decision-making regarding the necessity of renal biopsy in such patients at least 2 weeks post-transplant in conjunction with standard clinical assessment. Amendment 1 (A1): Is an observational study to develop and validate the clinical use of KidneyCare®.

This is a double-blind, randomized-withdrawal, placebo-controlled study consisting of 2 treatment periods, and a post-treatment Follow-up Period during which retreatment is permitted if needed.

The overall goal of this study is to determine the safety and feasibility of infusing adipose-derived mesenchymal stem cells directly into the artery of renal allografts with biopsy-proven rejection in order to reduce inflammation detected in the graft.   We contend that future studies will show that administering immunomodulatory cells directly into the allograft will be more effective and safer than the current approaches of delivering massive doses of systemic immunosuppression.

Study participation involves receiving mesenchymal stem cells (MSC), created from the adipose tissue (body fat) of a donor, and infused into the main artery of a transplanted ...

The aims of this study are to identify frailty trajectories and biomarkers of frailty after kidney transplantation. Subjects will be followed beginning immediately prior to kidney transplantation until 1 year after kidney transplantation. Frailty will be prospectively assessed using performance-based measures (Fried criteria and Short Physical Impairment Battery). The relationship between frailty measures and blood levels of promising candidate biomarkers will be analyzed.

The purpose of this study is to connect the findings of TruGraf (a peripheral blood RNA signature that has been shown to correlate with rejection in kidney transplants) with rejection episodes in kidney transplant patients that are managed using standard of care clinical protocols at the three Mayo transplant sites. 

The purpose of this study is to test the hypothesis that pregnancy post-transplant will increase the risk of adverse renal events (defined as acute rejection, reduction in GFR by 30%, new or worsening proteinuria, or graft-loss).  The risk will be increased in women with complications in pregnancy, such as preeclampsia or pre-term delivery. 

The purpose of this study of posoleucel ALVR105 is to assess the safety and tolerability of posoleucel ALVR105 in kidney transplant recipients. The key secondary objective is to test the hypothesis that the administration of posoleucel ALVR105 to kidney transplant recipients with BK viremia will demonstrate superiority in suppressing BK viral load compared with placebo.

Nonadherence to immunosuppression is associated with an increased risk for organ rejection, allograft vasculopathy, and death (De Geest et al., 2014). Immunosuppression nonadherence has been found to be a factor in up to 90% of late acute rejection events that occur after the first year following transplant, and in 13% to 26% of deaths among heart transplant recipients in single-center research studies (De Geest et al., 2005). A prospective cohort study found that for individuals who were nonadherent after their first year following transplant, the risk of a negative clinical event was doubled (Dobbels et al., 2004). In ...

The purpose of this study is to describe the association between Prospera dd-cfDNA measures and other diagnostic tests used to detect heart allograft rejection and/or njury, including histology, echocardiography and DSA, in the first post-transplant year. Additionally, to inform rates of clinical outcomes in a contemporary cohort of adult heart transplant recipients to determine power for a future randomized, controlled clinical trial.

The purpose of this study is to assess the clinical utility of surveillance using HeartCare testing services, in association with clinical care of heart transplant recipients.

The purpose of this study is to assess the long-term effectiveness and safety of L-CsA plus Standard of Care (SoC) in the treatment of BOS in single (SLT) and double lung transplant (DLT) recipients.

Enrollment will be limited to patients who have completed 48 weeks participation in either the BT-L-CsA-301-SLT (BOSTON-1) or BT-L-CsA-302-DLT (BOSTON-2) trial. All patients in this clinical trial will receive L-CsA in addition to Standard of Care, regardless of randomization arm in prior trials.

The purpose of this study is to evaluate L-CsA for the treatment of bronchiolitis obliterans syndrome in adults diagnosed with Bronchiolitis Obliterans Syndrome (BOS) following double-lung transplant. Patients will receive either L-CsA (5 mg) via the PARI Investigational eFlow® Device twice daily plus Standard of Care (SoC) treatment, or SoC alone, for a period of 48 weeks. All patients will be eligible to continue in an open-label extension trial of L-CsA following completion of BOSTON-2.

The purpose of this study is to to determine whether or not prior living kidney donors have an increased risk of bone fractures. The study will also determine bone structure and health in prior living donors as compared to matched controls.  

We will determine if living kidney donors are at increased risk of bone disease and fractures following kidney donation. This information will be valuable in informing future kidney donors of the risks of donation and in devising treatments, such as administration of vitamin D analogs like calcitriol, to ...

The purpose of this study is to determine the effectiveness of using a combination of two different drugs in preventing the transmission of HCV from a HCV positive donor to a HCV negative solid organ recipient. Both drugs are FDA-approved. Mavyret™ is currently used commercially to treat Hepatitis C and Zetia® is used commercially to treat high cholesterol.

The purpose of this study is to analyze L-CsA for the treatment of bronchiolitis obliterans syndrome in adults diagnosed with Bronchiolitis Obliterans Syndrome (BOS) following single-lung transplant. Patients will receive either L-CsA (5 mg) via the PARI Investigational eFlow® Device twice daily plus Standard of Care (SoC) treatment, or SoC alone, for a period of 48 weeks. All patients will be eligible to continue in an open-label extension trial of L-CsA following completion of BOSTON-1.

The study will prospectively determine the clinical utility of CMV cell-mediated immunity using the Quantiferon test. The investigators will use the assay results to tailor the duration of CMV prophylaxis in solid organ transplant patients.

The purpose of this study is to determine the set of assessments and biomarkers that could together constitute a robust and valid composite health risk model for accurate personalized estimation of one year NRM.

To assess the safety and feasibility of mesenchymal stem cells therapy in patients with transplant related bronchiolitis obliteran syndrome (BOS).

The purpose of this study is to evaluate safety, tolerability, pharmacokinetics, and effectiveness of SER-155 in adults undergoing hematopoietic stem cell transplantation to reduce the risk of infection and graft vs. host disease.

This study aims to measure the percentage of time spent in hyperglycemia in patients on insulin therapy and evaluate diabetes related patient reported outcomes in kidney transplant recipients with type 2 diabetes. It also aimes to evaluate immunosuppression related patient reported outcomes in kidney transplant recipients with type 2 diabetes.

The purpose of this study is to evaluate the effectiveness of ibrutinib in reducing the incidence of NIH moderate/severe chronic GVHD.

The purpose of this study is to evaluate the safety and tolerability of multiple ascending doses of AMG 592 in subjects with steroid refractory cGVHD. Phase 2 - The purpose is to evaluate the effectiveness of AMG 592 in subjects with steroid refractory cGVHD as measured by ORR at 16 weeks according to the 2014 cGVHD NIH Consensus Criteria.

The purpose of this study is to compare the effectiveness and safety of itolizumab versus placebo as first-line therapy for subjects with Grade III-IV aGVHD or Grade II with LGI involvement, in combination with corticosteroids.

The purpose of this study is to assess SNDX-6352, or Axatilimab, for individuals who have active chronic recurrent or refractory Graft versus Host Disease (cGVHD) whom have used at least two previous treatments and have not had an improvement in symptoms. This study evaluates the effectiveness, safety, and tolerability of axatilimab at three different dose levels. Participants can receive axatilimab for up to two years and could be in the study up to 28 months.

The study is a Phase II randomized, open label, multicenter trial designed to identify whether sirolimus is a potential alternative to prednisone as an up-front treatment for patients with standard-risk acute GVHD defined according to clinical and biomarker-based risk stratification. This trial incorporates both a novel up front GVHD therapy (sirolimus) as well as a novel BMT CTN developed acute GVHD biomarker test.

The purpose of this study is to deepen our understanding of the ARDS mechanism following transplantation through an analysis of cytokines, metabolomics and proteomics before ARDS occurs, and during the early phase of ARDS development.

This randomized phase III trial studies how well caspofungin acetate works compared to fluconazole or voriconazole in preventing fungal infections in patients following donor stem cell transplant. Caspofungin acetate, fluconazole, and voriconazole may be effective in preventing fungal infections in patients following donor stem cell transplant. It is not yet known whether caspofungin acetate is more effective than fluconazole or voriconazole in preventing fungal infections in patients following donor stem cell transplant.

The purpose of this study is to evaluate the safety and tolerability of PC945 for the prevention of fungal aspergillus infections in the lung in patients who have received a lung transplant.

The purpose of this study is to evaluate the effectiveness of vedolizumab when added to background aGvHD prophylaxis regimen compared to placebo and background aGvHD prophylaxis regimen on intestinal aGvHD-free survival by Day +180 in participants who receive allo-HSCT as treatment for a hematologic malignancy or myeloproliferative disorder.

The purpose of this study is to identify risk factors and potential predictors for NAFLD and NASH recurrence after liver transplantation.

To investigate the efficacy of autologous Epstein-barr virus (EBV)-specific T cells for the treatment of EBV positive Diffuse Large B Cell Lymphoma (DLBCL), Hodgkin Lymphoma (HL) and Post-transplant Lymphoproliferative Disease (PTLD) after failing first line treatment.

The primary objective of the United States Food and Drug Administration (FDA) for this study is to demonstrate non-inferiority in subjects who received an allogeneic BMT for subjects randomized to Rezafungin for Injection compared to subjects randomized to the standard antimicrobial regimen (SAR) for fungal-free survival at Day 90 (±7 days).

The primary objective of the European Medicines Agency (EMA) for this study is to demonstrate superiority in subjects who received an allogeneic BMT randomized to Rezafungin for Injection compared to subjects randomized to the SAR for fungal-free survival at Day 90 (±7 days).