Clinical Research Directory

Social Support Counseling Intervention for Kidney Transplant Candidates

Virtual Coaching for Potential Kidney Transplant Patients

CAR-T Cell Therapy for Desensitization in Kidney Transplantation

This research study is for people who have been waiting for a kidney transplant for at least one year, and who have a cPRA of 99.5% or higher. Having a cPRA of 99.5% or higher means that your immune system would reject 99.5% of kidneys available for transplant. The study will test whether new products called Chimeric Antigen Receptor T Cells (CAR T Cells), when given with chemotherapy, is safe and will reduce cPRA. The main study will last up to 2 years: Participants will have up to 30 clinic or hospital visits over a one-year period. If a transplant takes place, there will be 9 more visits after transplant. Long term follow up is required by the Food and Drug Administration (FDA) for 15 years after receiving CAR T cell. The primary objective is to evaluate the safety and feasibility of administering CART BCMA + huCART-19 following lymphodepletion, including determination of optimal tolerated regimen (OTR) and/or recommended phase 2 regimen, according to the incidence of dose limiting toxicity (DLT) in highly sensitized patients awaiting kidney transplant.

Letermovir for R+ Study

The purpose of this clinical trial is to find out whether a medication, called letermovir, can help prevent a virus called cytomegalovirus (CMV) in participants who receive a kidney or liver transplant and who have already been exposed the CMV. Participants will take letermovir for 84 days.

Rituximab in Renal Allograft Recipients Who Develop Early De Novo Anti-HLA Alloantibodies

The purpose of this study is to determine whether treatment with rituximab (anti-CD20, Rituxan®, MabThera®) in individuals who develop new anti-HLA antibodies after renal (kidney) transplant will promote longer-term survival of the transplanted kidney.The pilot study compares the use of rituximab (Rituxan®) + site-specific standard immunosuppression to placebo + site-specific standard immunosuppression in the treatment of circulating anti-HLA antibodies in subjects who develop de novo anti-HLA antibodies between 3-36 months after transplant.

The Effectiveness and Safety of Hypertonic Citrate Adenine-New (HCA-N) Solution for the Preservation of Kidney Grafts During Kidney Transplantation

To verify the effectiveness and safety of the HCA-N solution in actual clinical preservation, this study intends to conduct a prospective, randomized, and positive control clinical trial. Using the classic HTK solution as a reference, the study will focus on evaluating the performance of the HCA-N solution in terms of the incidence of delayed recovery of transplant kidney function and the speed of early renal function recovery, with the aim of providing better preservation solution selection and high-level evidence-based guidance for clinical practice in kidney transplantation.

Advancing Transplantation Outcomes in Children

This is a pediatric kidney transplant study comparing the safety and efficacy of an immunosuppressive regimen of belatacept and sirolimus to tacrolimus and Mycophenolate Mofetil (MMF). Two hundred participants will be randomized (1:1) to one of two groups within 24 hours following the transplant procedure. The duration of the study from time of transplant to the primary endpoint is 12-24 months.

Tailored mHealth Coaching and Social Resource Support in Kidney Transplantation

The purpose of this study is to learn if a mobile app, personalized coaching, and assistance from social workers can help improve outcomes for kidney transplant patients. Participants in this study will be randomized to one of 3 groups: usual care, use of mHealth app, or use of mHealth plus a dedicated social worker. Participants assigned to use the mHealth app will be required to download the app to their phone. All participants will complete surveys about their experience and symptoms at study enrollment then at 3 months and 6 months after study enrollment. Some participants may also be asked to participate in a semi-structured interview after the 6-month visit.

Antibiotics for Kidney Transplant Recipients

The goal of this clinical trial is to learn if a common antibiotic called trimethoprim-sulfamethoxazole (TMP-SMX) can help prevent urinary tract infections (UTIs) in children and young adults who recently had a kidney transplant. Most people take TMP-SMX for about 6 months after getting a kidney transplant. In this study, researchers want to see what happens if people keep taking it for 6 more months. The main questions this study is asking are: * Does TMP-SMX lower the number of UTIs in the first year after transplant? * What side effects or problems do participants have while taking TMP-SMX? Researchers will compare TMP-SMX to a placebo (a look-alike pill that does not contain any medication) to see if TMP-SMX works to prevent UTIs. Participants will: * Take either TMP-SMX or a placebo pill by mouth every day for 6 months * Have three visits to touch base with the study team about any issues * Complete short monthly online surveys about any symptoms or side effects * Share blood and urine test results from their regular transplant clinic visits

Strategies to Transform Kidney Care and Improve Pursuit of Transplant

Approximately 15% of the U.S. population has chronic kidney disease, and \~700,000 patients are in full kidney failure also called end-stage kidney disease (ESKD). The optimal treatment for ESKD is living donor kidney transplantation (LDKT), followed by deceased donor kidney transplantation (DDKT); however, the standard of care continues to be ongoing dialysis, which has poor clinical outcomes in comparison to LDKT and DDKT. Best practices to transform kidney care recommended by the Centers for Medicare and Medicaid Services (CMS), the American Society of Nephrology (ASN) and the 2019 Executive Order Advancing American Kidney Health Initiative include earlier detection of patients whose kidneys are deteriorating rapidly, introducing transplant as a potential treatment option earlier, optimally before their kidneys fail, improved dissemination of health literate transplant education tools, often through digital technology or mHealth, and increasing LDKT rates by helping patients locate living donors or motivating others to donate. Barriers at the patient-, support network-, clinician- and system-levels of the Socio-Ecological Model persist, including poor identification of high-risk patients, insufficient clinician time to discuss transplant, poor transplant knowledge, reluctance or insufficient support to ask living donors to donate, and disengaged friends and relatives, some of whom who might become living donors. While extensive policy and intervention efforts are underway, none have achieved significant increases in pursuit and receipt of transplant, especially LDKT rates. In 2017, Kaiser Permanente Southern California (KPSC), an integrated care system serving 24,000 CKD patients, partnered with the Transplant Research and Education Center (TREC) at Houston Methodist Research Institute (HMRI) and J.C. Walter Jr. Transplant Center Houston Methodist Hospital (HMH) to launch a multi-year plan for transforming CKD and ESKD care. Investigators now propose to conduct a pragmatic stepped wedge cluster randomized trial of a novel multilevel intervention to improve CKD and ESKD care, improve transplant rates and reduce disparities. One innovative component of the multilevel intervention is a state-of-the-art technology-supported mHealth application, developed in partnership with patients, to engage patients, family members, and potential living donors to improve their CKD knowledge, view transplant success stories, and seek kidney-related support to pursue transplant, including learning how to find living donors. Investigators also seek to identify moderators at various socio-ecological levels, especially factors influencing variations in effectiveness across different settings and among underserved patient subgroups known to have reduced access to transplant and build implementation tools to increase access to and pursuit of transplant within large integrated health systems including comparable systems (commercial, academic, safety net) across the U.S.

Hypothermic Machine Perfusion With Omnisol of Deceased Donor Kidneys Prior to Transplantation

Insufficient availability of organs from brain dead (DBD) and living donors has necessitated increased use of less than optimal organs from donation after cardiac death (DCD) or from extended criteria donors. Preservation of DCD organs using the current clinically applied preservation solutions is associated with up to 73% incidence of delayed graft function, highlighting the need for new preservation solutions designed to improve early graft function. Omnisol is expected to result in equivalent or improved kidney preservation as compared to currently marketed organ preservation solutions used for HMP.

Safety and Tolerability of IDO-1 Inhibition in the Prevention of EBV-related Pathology in EBV Negative Kidney Transplant Recipients Receiving an Organ From EBV Positive Donors

This clinical study will evaluate the safety and tolerability of an IDO-1 inhibitor in patients receiving a kidney transplant. The study includes individuals who have not previously been infected with Epstein-Barr virus (EBV) and who receive a kidney from a donor with prior EBV infection. Participants will receive the IDO-1 inhibitor or placebo in addition to standard medical care and will be monitored for side effects and other safety-related outcomes throughout the study.

NRP + ex Situ HMPO2 vs NRP Alone in DCD Kidney Transplantation

The goal of this clinical trial is to learn if the combination of Normothermic Regional Perfusion (NRP) at the time of organ procurement with ex situ Hypothermic Oxygenated Perfusion (HMPO2) of kidneys recovered from donors after circulatory death (DCD) is superior to NRP alone. The researchers will learn if the combined use of these technologies provides a benefit in terms of kidney transplant outcomes. The researchers will also learn about the patient quality of life after these transplants and if the use of these technologies is cost efficient. The main questions it aims to answer are: * Does NRP +HMPO2 provides a better DCD kidney function at 1 year post-transplant compared to NRP alone. * Are the postoperative complications and outcomes different between the two groups? * Is the quality of life of recipients different between the two groups? * Is the use of NRP +HMPO2 a cost effective strategy? Researchers will compare NRP and HMPO2 with NRP alone to see if the combined use of the technologies provides better transplant outcomes. Participants will: * Receive a kidney treated with one of the two strategies. * Visit the clinic as per usual clinical practice for checkups and tests * Report on their quality of life pre and post transplant * Undergo a kidney biopsy at one year to forecast long term transplant function

A Multicenter, Prospective Blood Collection Study in a Kidney Transplant Population

The purpose of this research is to collect blood samples and data from kidney transplant patients. The samples and data will be used for research and development of non-invasive test to detect donor-derived cell-free DNA (dd-cfDNA) in kidney transplant patients to evaluate the status of the transplanted organ.

Optimization of Therapeutic Drug Monitoring in Pediatric Kidney Transplant

The goal of this observational, pharmacokinetic study is to evaluate factors that change drug exposure in pediatric kidney transplant recipients so investigators can make better dosing decisions. The main question it aims to answer is: Can investigators quantify the impact of factors that change with time (like food intake and medication adherence) on tacrolimus and mycophenolate? Our hypothesis is that inconsistent drug and food intake will increase day to day variability in drug exposure, and investigators can use this information to help us make decisions about what is the best dose. Participants will participate in the study on 7 days over the course of 1 year. On day 1, participants will be asked questions to see if participants are able to be in this study. Investigators will ask what immunosuppression participants are taking, how tall and how much participants weigh. On day 2, participants and their parent/guardian will be taught how to use the device to collect the blood samples and decide on which days to collect them. On days 3-6, participants will collect blood samples 4 separate times over about 1 year. Collection days should try to be scheduled every 3 months (+/- 2 weeks). On each collection day, participants will collect a sample 7 different times over 9 hours. Each collection will only take approximately 5 minutes. Participants will be asked to collect a blood sample immediately before the morning dose of tacrolimus or mycophenolate, and 20 min, 1hr, 3hr, 4hr, 6hr, 9hr after the dose. Also on collection days, participants will receive text messages and be asked to complete different assessments about their medications, diet, and how they feel by responding to the texts. On day 7, participants will have the opportunity to participate in an interview where investigators will ask about participants' experience in the study.

(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.

Effects Of Propofol And Sevoflurane On Plasma Mirna Levels İn Living Kidney Donors

Surgical interventions and associated tissue trauma induce a complex systemic inflammatory stress response characterized by the activation of neuroendocrine, metabolic, and immunological systems. Donor nephrectomy operations performed in living kidney donors are among the unique clinical models where these inflammatory cascades and cellular stress pathways are most intensely observed, due to major surgical trauma and unavoidable ischemia-reperfusion injury during organ clamping. Recent studies have demonstrated that microRNAs (miRNAs), which epigenetically regulate gene expression at the post-transcriptional level, serve as key determinants in perioperative medicine regarding immune response, resolution of inflammation, and cellular adaptation processes . Among our target molecules, miR-146a acts as a dominant, negative regulator (brake mechanism) of the innate immune response , while miR-155 plays an important role in the inflammatory response by triggering pro-inflammatory macrophage activation . Conversely, miR-21 displays an anti-apoptotic adaptation mechanism against tissue damage by directly targeting programmed cell death pathways . Propofol, an intravenous agent, and sevoflurane, a volatile anesthetic, are known to differentially impact microRNAs in circulating extracellular vesicles during major surgical interventions . The original value of this study lies in being the first randomized clinical trial in the literature to comprehensively examine the acute comparative effects of these two anesthesia techniques on perioperative inflammatory miRNA expression profiles in completely healthy living kidney donors. The objective is to comparatively evaluate the dynamic changes in plasma miR-146a, miR-155, and miR-21 levels under general anesthesia maintained with propofol or sevoflurane. Regarding the methodology, the research will be conducted on 34 voluntary living kidney donors aged 18-65 in the ASA I-II risk group, scheduled for elective donor nephrectomy at Gaziantep University Faculty of Medicine Şahinbey Training and Research Hospital, Department of Anesthesiology and Reanimation. Donors will be allocated into two equal groups (Group P: Propofol, n=17 and Group S: Sevoflurane, n=17) using a computer-assisted block randomization method, with anesthesia maintenance titrated to a Bispectral Index (BIS) of 40-60. Peripheral venous blood samples will be collected into K3-EDTA tubes at three different time points: before anesthesia induction (T0: basal), at the end of surgery (T1), and at the postoperative 24th hour (T2). In accordance with project management and data privacy principles, personal identity information will be masked, and each participant will be recorded in the system with a unique "File Number" (Dosya No). In the molecular phase conducted in coordination with the Department of Medical Genetics laboratory, total RNA isolation and cDNA synthesis will be performed from plasma samples separated under cold chain rules. Expression levels of target genes and the U6 snRNA internal control will be quantitatively analyzed in duplicate using Real-Time Quantitative PCR (RT-qPCR). Fold change ratios will be calculated using the method and analyzed with biostatistical methods including Shapiro-Wilk, Student's t-test, and Mann-Whitney U test. As for the widespread impact, the molecular findings to be obtained will elucidate the epigenetic reflections of general anesthesia applications on systemic inflammation and organ protection capacities for the first time. These results will lead to the development of the safest, evidence-based anesthesia protocols that will minimize the inflammatory load caused by surgical trauma at the cellular level in living kidney donors, increase donor comfort and postoperative recovery quality, and protect kidney graft quality against ischemic injury, providing a strong scientific foundation for international transplantation guidelines.

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. Currently, only solid biopsy of the graft makes it possible to establish the diagnosis of graft rejection, and to characterize its cellular origin based on the Banff classification. Several studies have shown the possibility of identifying the tissue origin of DNA circulating in the blood, in healthy subjects, on the basis of the epigenetic properties of circulating DNA. In addition, in kidney transplant subjects, an increase in the quantity of circulating DNA originating from the graft in the blood and urine has been shown as well as an increase in urinary chemokine levels during renal dysfunction (notably dismiss). Thus, the company CGenetix in partnership with INSERM units 1155 and 1151 is developing a method to identify and characterize kidney transplant rejection early, through the detection of epigenetic biomarkers on circulating DNA targeting different fractions of the kidney (glomerular, tubular, peritubular capillary and vascular). The main objective is to study the diagnostic performance of the quantity of DNA of renal origin in kidney transplant patients in the blood and in the urine (expressed in copies/ml) for the diagnosis of type Rejection mediated by kidneys. antibody (ABMR) established by kidney graft biopsy (gold standard) and according to the Banff 2022 classification.

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. The study team wants to study how the microbiome affects how the body processes the transplant medication.

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 (GraftAssureCore and GraftAssureDx) assay. This will also be correlated with the biopsy yield and treatment decisions. The GraftAssure assay is a diagnostic test intended for the quantitative measurement of dd-cfDNA in plasma from kidney transplant recipients. The test is minimally invasive, and is intended to be used in conjunction with standard clinical assessment and other laboratory findings as an aid in the detection of allograft rejection.

Immunosuppression Optimization Using The Prospera Assay In Kidney Transplant Recipients (IMPAKT)

IMPAKT is a research study that looks at whether a blood test called Prospera™ can help doctors better adjust anti-rejection medications, compared to the usual way doctors manage these medications without using this test.

Prediction and Prevention of Bloodstream Infections After Kidney Transplantation

Kidney transplant recipients take medicines that suppress the immune system to prevent rejection of the transplanted kidney. As a result, they have a high risk of infections, especially urinary tract infections (UTIs). Some of these infections can spread to the bloodstream and cause serious illness, hospitalization, loss of kidney function, or death. Currently, there is no established strategy to prevent these serious bacterial infections in kidney transplant recipients who are at highest risk. The PREDICT study is investigating whether a low daily dose of the antibiotic pivmecillinam can reduce the risk of bacterial urinary tract infections and bloodstream infections after kidney transplantation. The study focuses on kidney transplant recipients who have bacteria detected in their urine during the first month after transplantation, as previous research suggests that these patients have a particularly high risk of developing serious infections later. In this randomized, double-blind, placebo-controlled trial, 180 adult kidney transplant recipients will be assigned by chance to receive either pivmecillinam or a matching placebo from 1 to 6 months after transplantation. Neither participants nor study staff will know which treatment has been assigned during the study. All participants will continue to receive standard post-transplant care and monitoring. The main goal of the study is to determine whether prophylactic pivmecillinam can reduce the occurrence of infections caused by Enterobacterales bacteria, including urinary tract infections and bloodstream infections, during the first 6 months after transplantation. The study will also evaluate the effects of treatment on serious clinical outcomes, safety, quality of life, antimicrobial resistance, and long-term kidney transplant outcomes. The study hypothesis is that targeted antibiotic prophylaxis with pivmecillinam in kidney transplant recipients at increased risk of infection will reduce the incidence of Enterobacterales urinary tract infections and bloodstream infections during the high-risk period after transplantation compared with placebo.

Cemiplimab for Kidney Transplant Recipients With Advanced Cutaneous Squamous Cell Carcinoma

This is a phase II, multicenter, open label, single arm, non-randomized trial using Simon's optimal two-stage design to evaluate the efficacy of cemiplimab in kidney transplant recipients with advanced cutaneous squamous cell carcinoma. The hypothesis being tested is that cemiplimab alongside standardized immune suppression will generate anti-tumor activity without triggering allograft rejection.

Effect of Terlipressin for Intraoperative Blood Pressure Management in Kidney Transplantation

Prospective double blind randomized controlled trial. By randomizing patients undergoing kidney transplantation into a conventional catecholamine drug (dobutamine) blood pressure maintenance group and a terlipressin-complexed dobutamine group, the investigators compared the effect of intraoperative blood pressure maintenance and the dosage of the vasoactive drug, postoperative graft function, delayed graft function, and other related complications between the two groups, in order to demonstrate whether the use of terlipressin for blood pressure regulation during kidney transplantation is superior to the existing treatments.

Comparison of the Effects of General Anesthesia and Combined Spinal-Epidural Anesthesia on Ferroptosis, Humanin and MOTS-c Levels in Renal Transplantation

Renal transplantation is the most effective renal replacement therapy for patients with end-stage renal disease. Ischemia-reperfusion injury may adversely affect graft function and long-term outcomes. Ferroptosis has recently emerged as a potential mechanism involved in ischemia-reperfusion injury, while the mitochondrial-derived peptides humanin and MOTS-c are thought to exert protective effects against oxidative stress. However, the effects of different anesthetic techniques on these biomarkers in kidney transplant recipients have not been investigated. This prospective controlled study aims to compare the effects of sevoflurane general anesthesia (SGA) and combined spinal-epidural anesthesia (CSEA) on serum ferroptosis markers, humanin, and MOTS-c levels in adult kidney transplant recipients. Blood samples will be obtained perioperatively for biomarker analysis. The primary objective of the study is to evaluate the effects of the anesthetic technique on serum ferroptosis markers, humanin, and MOTS-c levels. Secondary objectives include evaluating early graft function and postoperative outcomes by assessing the incidence of delayed graft function, postoperative serum creatinine levels, requirement for dialysis, urine output, length of hospital stay, and the association of these outcomes with perioperative biomarker levels.