Clinical Research Directory

ASSISTED FLUID MANAGEMENT SYSTEM IN KIDENY TRANSPLANTATION

The NEPHRON study is a prospective, randomized controlled trial evaluating the use of an automated fluid management system during kidney transplantation. A total of 48 adult patients will be randomly assigned to either an Assisted Fluid Management (AFM) group or a standard care group. The primary objective is to compare the total volume of intravenous fluids administered during surgery. Secondary outcomes include intraoperative hypotension, vasopressor requirements, postoperative kidney function, and complications. The study aims to assess whether AFM-guided therapy can optimize intraoperative fluid administration in kidney transplant recipients.

The KidneyCARE (Community Access to Research Equity) Study

For chronic kidney disease (CKD), there is a lack of unique and powerful platform for patient engagement, research studies and public health advocacy work. The National kidney Foundation (NKF) launched the first nationwide registry for people at all stages and types of CKD, including people on dialysis and kidney transplant recipients, called the KidneyCARE Study (kidneycarestudy.org). The KidneyCARE Study is a non-interventional research study which means participants will not have to take medications or do any additional tests to participate. They are simply asked to share some personal and health information, and their experiences with their disease through a secure portal. The Study also collaborates with health systems to obtain additional electronic health records (EHR) data. This unique combination of data collected will address the gap of individualized educational resources and will enhance clinical research, clinical care, and health policy decisions to be centered on the patient. The Study is all online and can be accessed any time of day at kidneycarestudy.org. Participation is voluntary and free.

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.

A Trial to Evaluate the Safety, Tolerability and Efficacy of AIC263029 in Kidney Transplant Recipients With BKV Infection

The goal of this clinical trial is to learn if AIC263029 is safe and well tolerated in adult kidney transplant recipients with BK virus (BKV) in the blood (viremia). The study will also examine how the body processes AIC263029 and whether it lowers BKV levels in the blood. Researchers will compare AIC263029 to a placebo (a look-alike injection with no active drug). Participants will be assigned by chance to receive AIC263029 or placebo and will receive weekly injections under the skin for 4 weeks. Participants will have clinic visits and blood tests during treatment and follow-up to monitor safety and measure BKV levels, and will be followed for up to about 24 weeks after treatment.

Phenotype Guided Vasoactive Medication During Kidney Transplantation

The goal of this clinical trial is to learn if vasopressin improves the body's response to intravenous fluids during kidney transplantation in patients who have relaxed blood vessels. Researchers will compare the results of vasopressin to those who received calcium chloride.

Technology-enabled Social Network Intervention to Increase Live Donor Kidney Transplantation

The study is a 2-arm randomized controlled trial among patients referred for kidney transplant evaluation at a single transplant center to compare the effects of a digital-analog intervention to increase living-donor kidney transplant access (KT-CONNECT) versus usual care. Following consent and baseline assessment, participants are randomized with equal allocation to 2 treatment arms: the KT-CONNECT intervention or Usual Care

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.

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 includes 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 later serious infections. 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 main 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.

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.

Pilot Social Support Counseling Intervention for Kidney Transplant Candidates

Feasibility pilot social support counseling intervention for kidney transplant candidates

The Effect of the 5th Sign Intervention on Medication Adherence in Kidney Transplant Recipients

The goal of this randomized controlled trial is to evaluate the effectiveness of the "5th Sign" intervention program-a multi-component strategy based on the Socio-Ecological Model that incorporates goal setting, action planning, medication education, problem-solving, and counseling, delivered via a custom mobile health application. The main questions it aims to answer are: * To examine the effect of the 5th Sign intervention on immunosuppressive medication adherence (measured biologically, via self-report, and mobile monitoring) in kidney transplant recipients. * To evaluate the effect of the intervention on clinical health outcomes, specifically including infection, mortality, Blood Urea Nitrogen (BUN) and creatinine levels, acute/chronic rejection, and graft loss. * To assess the effect of the intervention on the incidence of immunosuppressive drug-related side effects. Researchers will evaluate the 5th Sign intervention to see if the mobile health app and structured counseling are effective in improving medication adherence and patient outcomes. Participants will: * Be randomly assigned to either the intervention group (using the 5th Sign intervention) or the control group for a total study period of 6 months. * (If in the intervention group) Participate in active counseling and interviews for the first 3 months, followed by a 3-month monitoring period. * (If in the intervention group) Use the mobile health application continuously for 6 months for medication reminders and tracking, with their app usage evaluated on a monthly basis. * Complete questionnaires (regarding medication usage and side effects) and provide blood samples (to measure biological adherence and kidney function) twice: at the beginning of the study and at the end of the 6-month study period.

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.

Proteogenomic Biomarker Panels in a Serial Blood & Urine Monitoring Study of Kidney Transplant Recipients

There is a need to develop blood and/or urine tests that will help to detect early signs of rejection in people who have had kidney transplant. Researchers will examine blood, urine, and tissue samples and try to identify genetic markers for certain conditions like rejection, response to therapy, and scarring of the kidney. By studying gene patterns, researchers hope to be able to diagnose these conditions earlier and improve kidney survival.

AI-Assisted vs Usual Follow-up in Kidney Transplantation

The goal of this clinical trial is to learn whether kidney transplant follow-up visits run by a health professional using an artificial intelligence (AI) computer helper are as good as usual follow-up visits with a doctor. People who receive a kidney transplant need check-up visits for the rest of their lives. These visits help keep the new kidney working well. As more people live longer with a transplant, clinics get busier. An AI helper may make visits more consistent and free up doctor time. This idea has not yet been tested well in real clinics. The main questions this study will answer are: Are AI-assisted visits as good as usual doctor visits? Trained reviewers will rate the quality of each visit. The reviewers will not know which type of visit they are rating. Are patients as satisfied with their visit? How long does the visit take, and how much time does the clinician spend on paperwork? Do the visits do a better job of checking key items, such as screening tests, vaccines, and transplant medicines? Are the visits safe for patients? Adults can take part if they have a working kidney transplant, if the transplant was at least 6 months ago, and if they can complete a routine visit on their own. Researchers will place 140 adults into two groups by chance, like flipping a coin. One group will have a visit run by a health professional who uses the AI helper. The other group will have a usual visit with a doctor. In both groups, the AI cannot order tests, change medicines, or make a diagnosis on its own. A clinician checks and approves everything. Participants will take part in one study follow-up visit. The visit will be audio-recorded so reviewers can rate it later. After the visit, participants will fill out a short satisfaction survey on a tablet.

Treg Therapy in Subclinical Inflammation in Kidney Transplantation

The purpose of this study is: * To see if polyTregs can reduce inflammation in a transplanted kidney. * To find out what effects, good or bad, polyTregs will have in the kidney recipient. * To find out what effects, good or bad, taking everolimus after polyTregs will have in the kidney recipient.

Effects of Inhibiting Early Inflammation in Kidney Transplant Patients

During transplant surgery, there is a period of time when a donated kidney is removed from a donor's body and stored until the time of the transplant surgery. The storage procedure results in buildup of various proteins within the kidney that can injure the donated kidney after it is transplanted. One of these proteins is tumor necrosis factor-alpha (TNF-alpha). The purpose of this study is to evaluate whether taking infliximab, which blocks tumor necrosis factor alpha (TNF-alpha), just prior to transplant surgery, along with usual transplant medicines will protect the donated kidney from damage caused by TNF-alpha and help keep the transplanted kidney healthy for a longer period of time.

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.

Evaluation of an Instructional Video About Medication Management During Admission and Medication Adherence for Kidney Transplantation and in the Outpatient Clinic in a Dutch University Hospital.

The goal of this RCT is to evaluate the effect of the instructional video on improving patient compliance and reducing medication errors. The study will include adult kidney transplant recipients (18 years or older) at Erasmus MC who have undergone a kidney transplantation starting January 2026. The main questions it aims to answer: The primary aim of this study is to assess whether our developed video instruction, compared with the traditional verbal instruction, both of which are given shortly before training during admission, reduces the number of medication errors in kidney transplant patients. The study will also examine the correlation between patient characteristics (such as age, comorbidities, and language proficiency) and medication errors. Additionally, patient-reported medication errors will be measured through a questionnaire completed during follow-up visits at the outpatient clinic, which is part of standard care. The instructional video will be evaluated by a short questionnaire.

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.