Kidney Transplant

Researchers are investigating a new, non-invasive method to monitor kidney function after transplantation using advanced non-contrast Magnetic Resonance Imaging (MRI). This study aims to create individualized baselines for transplanted kidneys by scanning donors before donation, allowing earlier detection of kidney problems compared to current blood tests or biopsies. It includes both donor-recipient pairs and recipients without donor data, primarily from deceased donors, to evaluate MRI's ability to track kidney health over time. Participants are divided into two main groups: one where donors undergo pre-transplant MRI to establish a personalized baseline for their kidney before transplant, and recipients are followed post-transplant to compare function against this baseline; the other group includes recipients without donor MRI data to validate MRI's standalone monitoring ability. The study also assesses body composition and metabolic health to better understand their impact on transplant kidney function. During the study, participants will undergo scheduled non-contrast MRI scans alongside clinical, laboratory, and body composition assessments. Data such as serum creatinine, eGFR, and biopsy results when available will be collected to correlate with MRI findings. The main outcome is the diagnostic accuracy of MRI for detecting transplant kidney rejection and dysfunction over up to five years. Approximately 1000 participants will be enrolled to provide robust data for developing a precise, individualized monitoring tool for kidney transplant patients.

This research focuses on kidney transplant patients to collect blood samples and clinical data for developing a non-invasive test that detects donor-derived cell-free DNA (dd-cfDNA) to assess the condition of transplanted kidneys. The study is prospective and multicenter, involving participants who have had a kidney transplant and are undergoing an indication biopsy. The goal is to improve monitoring of the transplanted organ's status. Participants will provide whole blood samples at the time of their indication biopsy, before the biopsy procedure itself. Additionally, leftover de-identified retrospective genomic DNA (gDNA) samples from the kidney donors will be collected for paired analysis. This approach helps researchers study dd-cfDNA in a real-world transplant population. Participants will be involved through blood sample collection and clinical data gathering during their biopsy visits. Researchers will monitor the detection of donor-derived cell-free DNA in whole blood over an 18-month period. The study involves no investigational treatments, focusing on observation and sample analysis. Participation duration and follow-up details align with the biopsy schedule and sample collection requirements.

Researchers are evaluating pegcetacoplan, a complement (C3) inhibitor drug, in adults at high risk of delayed graft function (DGF) after receiving a kidney transplant from a deceased donor. This Phase 3, randomized, placebo-controlled, and double-blinded study aims to assess the effectiveness and safety of pegcetacoplan in helping kidney transplant patients who have end-stage renal disease and require dialysis. The study is sponsored by Apellis Pharmaceuticals, Inc. Participants will receive either pegcetacoplan or a placebo. Both treatments start with a 20 mL intravenous infusion and then continue with subcutaneous infusions. The study includes multiple assessment time points, such as through Day 90 and up to Week 52 following surgery, to monitor kidney function and graft survival. The treatment period involves careful medical management including use of medications like ATG, corticosteroids, and tacrolimus. During the study, participants will be closely monitored for dialysis needs, urine output, kidney function (eGFR), and rejection-free survival through various tests and clinical evaluations. Researchers will track the time to freedom from dialysis and changes in kidney function over time. Participants will be followed for safety and outcomes until at least 52 weeks after their transplant. The total duration includes screening, treatment, and follow-up phases to gather comprehensive data on the drug's impact.

Researchers are evaluating the effects of extracorporeal photopheresis (ECP) therapy in patients who have undergone lung transplantation and have subclinical antibody-mediated rejection with persistent donor-specific antibodies (dnDSAs). The study aims to determine whether ECP can reduce the mean fluorescence intensity (MFI) of these antibodies, and assess its impact on acute cellular rejection (ACR), clinical antibody-mediated rejection (AMR), chronic lung allograft dysfunction (CLAD), infections, survival, adverse events, and other immunological markers. The trial will randomly assign 80 patients into two groups of 40 each. One group will receive ECP treatment starting within one week after randomization, consisting of two-day treatment cycles every two weeks for the first two months, followed by monthly two-day cycles for six months. The control group will be observed without receiving active treatment, representing the current standard of care. Researchers will compare outcomes between the groups, including immunophenotyping, miRNA profiling, cytokine expression, gene expression of peripheral blood mononuclear cells, and proteomic analysis. Participants will be monitored over six months to evaluate changes in dnDSA levels and clinical outcomes such as rejection episodes, infections, survival, and adverse effects. Assessments will include laboratory tests and immunological profiling to understand the mechanisms of ECP. This study is sponsored by the Medical University of Vienna and involves patients who are clinically stable with persistent dnDSAs and no signs of graft dysfunction after bilateral lung transplantation.

This research aims to assess the benefits and risks of switching adolescent kidney transplant recipients aged 12 to under 18 years from a calcineurin inhibitor-based immunosuppressive regimen to a belatacept-based regimen. The study also evaluates how well these adolescents adhere to their immunosuppressive medications. The trial is a phase 3, open-label, randomized study sponsored by Bristol-Myers Squibb, focusing on a specific patient group with stable kidney function following transplantation. Participants are randomly assigned to one of two groups: one group switches from their current calcineurin inhibitor therapy to belatacept, with a period of overlap followed by tapering off the calcineurin inhibitor; the other group continues their existing calcineurin inhibitor-based treatment. Both groups receive other immunosuppressive drugs such as mycophenolate mofetil, enteric-coated mycophenolate sodium, and corticosteroids as needed. The study monitors participants for up to 24 months after randomization. During the study, participants undergo regular assessments including kidney function tests using estimated glomerular filtration rate (eGFR), monitoring of proteinuria, blood pressure, immunosuppressive medication adherence, and safety laboratory parameters such as lipid and glucose levels. Researchers also track adverse events, graft survival, rejection episodes, and immune responses. The main measure of success is the proportion of participants who maintain a functional kidney graft with adequate eGFR at 24 months. Participants are followed closely throughout the study to gather comprehensive data on treatment effects and adherence.

Researchers are evaluating the safety, tolerability, and effectiveness of efgartigimod PH20 SC given by a prefilled syringe for people who have Antibody-Mediated Rejection (AMR) after a kidney transplant. This phase 2, randomized, double-blinded, placebo-controlled study aims to understand how this treatment works alongside standard immunosuppression therapy in this population. Participants will be randomly assigned to one of three groups: one receiving efgartigimod PH20 SC plus their usual immunosuppressive drugs, another receiving efgartigimod PH20 SC for 24 weeks followed by placebo for the next 24 weeks alongside immunosuppression, and a third group receiving placebo plus standard immunosuppression. The treatment period lasts 48 weeks, followed by an observational follow-up of about 24 weeks, totaling up to 78 weeks in the study. Throughout the study, participants will be monitored for side effects, treatment discontinuation, and changes in kidney function using blood tests, kidney biopsies, and urine tests. Researchers will also track drug levels and antibody responses. Participants will remain on their standard immunosuppression medications during treatment and will be followed regularly for up to 78 weeks to assess safety and kidney health.

Researchers are evaluating the efficacy and safety of frexalimab compared to tacrolimus in adults aged 18 to 70 years who are undergoing their first kidney transplant and have a low to moderate risk of graft rejection. This study is an open-label, randomized trial sponsored by Sanofi, designed as a seamless Phase 2/3 trial. The goal is to assess treatment outcomes over a period of up to five years. Participants are randomly assigned to receive either frexalimab or tacrolimus. Frexalimab treatment starts with an intravenous dose followed by maintenance doses given subcutaneously via an on-body delivery system. The study lasts up to about five years with approximately 38 visits planned. Tacrolimus is administered orally as capsules. The study also includes other immunosuppressive drugs as part of the treatment regimen. During the trial, participants will have regular assessments including kidney function tests (eGFR), proteinuria measurements, monitoring for graft rejection and survival, and evaluation of side effects related to immunosuppressive therapy. Researchers will also track antibody development, blood pressure, cholesterol levels, and occurrence of new diabetes. Safety monitoring will continue throughout the five-year period to evaluate overall participant and graft outcomes.

This trial investigates polyomavirus infections (BKPyV) in people who have received kidney or simultaneous pancreas-kidney transplants. The study aims to evaluate how reducing or modifying immunosuppression, with or without intravenous immunoglobulin (IVIG), affects BKPyV infection, transplant function, graft loss, acute rejection, immunosuppression levels, and survival. BKPyV infection is a serious complication due to the immune system suppression needed after transplantation, which can increase infection risks and damage the transplant. Participants will be randomly assigned to one of two groups: one receiving immunosuppression reduction or modification plus IVIG, and the other receiving immunosuppression reduction or modification alone as part of standard care. The immunosuppression adjustments may include dose reductions or switches to less potent medications. IVIG is an antibody treatment with potential antiviral and immune-modulating effects, used here as an additional therapy for BKPyV infection. During the study, participants will be monitored for up to 48 weeks with assessments including viral load, kidney function (eGFR), transplant rejection, antibody presence, infection events, hospitalizations, quality of life, cancer diagnosis, and adverse events. The main outcome measured at 11 to 13 weeks combines death, graft loss, kidney function decline, rejection, viral load, and immunosuppression load. Safety and treatment effects will be closely followed throughout the study period.

Researchers are evaluating the safety and effectiveness of abdominal wall transplantation to repair abdominal wall defects. This treatment may be done alone or along with another organ transplant. The study involves a small group of participants and aims to assess how well the transplanted abdominal wall restores function. Participants will receive either an isolated abdominal wall transplant or an abdominal wall transplant combined with another solid organ transplant. All participants will be given standard immunosuppression therapy similar to that used in other non-vascularized composite allograft organ transplants. The study will take place over 18 months at Duke University Medical Center. During the 18-month study period, participants will be closely monitored to see if the transplanted abdominal wall remains viable and functional. Researchers will evaluate the success of the transplant and monitor the participants’ health and response to treatment throughout this time. The primary measure is the number of subjects with a viable abdominal wall transplant at 18 months.

Researchers are investigating non-invasive methods to diagnose and manage subclinical acute rejection in kidney transplant patients. The study focuses on comparing the use of 18-fluoro-deoxy-glucose positron emission tomography combined with computed tomography (18FDG PET/CT) with the standard renal biopsy performed approximately three months after transplantation. This approach aims to reduce the need for invasive biopsies and support decisions on corticosteroid withdrawal by detecting metabolic activity indicative of rejection. Participants undergo 18FDG PET/CT imaging on the day of their scheduled surveillance biopsy. Based on biopsy and PET/CT results, patients are categorized into three groups: those with humoral rejection receive standard treatment and exit the study; those without humoral rejection but with high metabolic activity on PET/CT also continue standard care; and those without humoral rejection and low metabolic activity have their corticosteroid treatment gradually reduced. Throughout the study, kidney transplant patients receive regular assessments including histological analysis of biopsy samples by blinded pathologists and PET/CT imaging with standardized procedures. Researchers measure metabolic activity ratios and track outcomes such as prediction of rejection at three months and corticosteroid withdrawal at six months. Follow-up includes monitoring graft rejection at six months and one year, providing comprehensive data on the safety and utility of PET/CT in managing subclinical rejection.