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 MRIs 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 MRIs 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 organs 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 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.

Researchers are evaluating the benefits and risks of switching adolescent kidney transplant recipients aged 12 to less than 18 years from a calcineurin inhibitor-based immunosuppressive treatment to a belatacept-based regimen. This study aims to compare these two treatment approaches and assess how well patients adhere to their immunosuppressive medications. The trial is a phase 3, randomized study focusing on treatment outcomes for young kidney allograft recipients. Participants are assigned to one of two groups one group will convert from their current calcineurin inhibitor CNI treatment to belatacept, with a tapering and discontinuation of CNI, while the other group will continue their existing CNI-based regimen. The treatments involve specified dosing schedules of belatacept and other immunosuppressive drugs such as tacrolimus, cyclosporine A, mycophenolate mofetil, enteric-coated mycophenolate sodium, and corticosteroids. The study follows participants over a period of 24 months after randomization. Throughout the study, participants will be monitored for kidney function, graft survival, acute rejection episodes, adherence to medication regimens, and safety measures including lab tests and blood pressure. Researchers will collect data on estimated glomerular filtration rate eGFR, proteinuria, immunogenicity, and adverse events at multiple time points up to 24 months. This comprehensive monitoring helps evaluate the long-term effects and tolerability of switching to belatacept in adolescent kidney transplant recipients.

Researchers are evaluating the efficacy and safety of frexalimab compared to tacrolimus in adults undergoing kidney transplantation. This open-label, randomized study focuses on adults aged 18 to 70 who have low-to-moderate immunologic risk of graft rejection and are receiving their first kidney transplant. The trial is designed as a seamless Phase 23 study sponsored by Sanofi, aiming to better understand outcomes related to kidney transplant rejection and graft survival. Participants will receive either frexalimab or tacrolimus as part of their treatment. The first dose of frexalimab will be given intravenously, followed by subcutaneous doses administered via an on-body delivery system. Tacrolimus will be given as capsules orally. The study and treatment duration will be up to approximately 5 years, with about 38 visits planned during this period to monitor participant progress and treatment effects. During the study, participants will undergo various assessments including measurements of kidney function eGFR, proteinuria, incidence of rejection episodes, donor-specific antibodies, and survival rates of both the participant and the graft. Safety will be monitored through reports of adverse events, laboratory tests, vital signs, and device-related events. The primary outcome measure is the composite efficacy failure rate biopsy-proven acute rejection, graft loss, and death within 1 year post-transplantation. Secondary outcomes extend up to 5 years, covering kidney function and cardiovascular health among others. Participants will be closely monitored throughout the trial duration to assess long-term safety and efficacy.

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 studying CID-103, a new anti-CD38 monoclonal antibody, to evaluate its safety and effectiveness in adults with active and chronic antibody-mediated rejection ABMR following kidney transplant. This global Phase 12 trial aims to find a safe dose range and assess clinical efficacy to provide potential new treatment options for people who do not respond well to current therapies. The study has two parts Part A tests increasing doses of CID-103 to assess safety, tolerability, and find the optimal dose, while Part B enrolls about 40 participants to further evaluate safety and effectiveness at that dose. CID-103 is administered by intravenous infusion, starting with a priming dose of 150 mg in the first week, then continued at the target dose. Treatment may last up to 12 months, followed by a post-treatment safety follow-up period. Participants will undergo regular assessments including biopsies, laboratory tests, and monitoring for adverse events and immune responses. The main outcomes measured include safety events, serious adverse events, antibody development, and biopsy-proven resolution of rejection activity. The study lasts up to 65 weeks, during which kidney function, protein levels, donor-specific antibodies, and other markers will be closely monitored to evaluate treatment effects and participant safety.

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 PETCT 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 PETCT imaging on the day of their scheduled surveillance biopsy. Based on biopsy and PETCT 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 PETCT 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 PETCT 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 PETCT in managing subclinical rejection.

Researchers are evaluating the safety and effectiveness of two different immunosuppressive drug regimens in children and young adults who have received a kidney transplant. This pediatric study focuses on comparing a treatment combining belatacept and sirolimus with a standard regimen of tacrolimus and Mycophenolate Mofetil MMF. The trial aims to improve transplant outcomes and is sponsored by the National Institute of Allergy and Infectious Diseases NIAID. Participants will be randomly assigned within 24 hours after their transplant to one of two groups. One group will receive antithymocyte globulin ATG, a steroid taper, belatacept infusions, a short tacrolimus bridge, and then switch to sirolimus around one month after transplant. The other group will receive ATG, a steroid taper, tacrolimus, and MMF. Belatacept is given intravenously on a scheduled timeline up to 24 months, and sirolimus dosing depends on participant weight. During the 12 to 24 months of follow-up, participants will have regular assessments including blood tests for donor-specific antibodies and kidney function, as well as biopsies to detect graft rejection and infections. Researchers will monitor adverse events and track outcomes such as infection rates and transplant complications. The study includes detailed lab monitoring and aims to measure the incidence of transplant-related complications up to 96 weeks post-transplant.