Kidney Transplantation

45

Review clinical trials related to Kidney Transplantation. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

Phase 2 Study of ALXN2030 in Patients With Antibody-Mediated Rejection After Kidney Transplantation

The primary objective of this study is to evaluate the efficacy of ALXN2030 compared with placebo on biopsy proven histologic resolution in participants with active or chronic active antibody-mediated rejection (AMR) at Week 52.

Participants needed: 45
Trial details
Phase: Phase 2Age: 18-75Biological sex: AllType: InterventionalSponsor: Alexion Pharmaceuticals, Inc.Updated: Jun 18, 2026Locations: 55
Eligibility criteria

Kidney transplant received ≥ 6 months [+8]

TCMR, according to the Banff grade ≥ 1 [+8]

Status: Recruiting

Evaluation of Dipyridamole in Preventing Post-Transplant Hypophosphatemia in Kidney Transplant Recipients

The primary goal is to determine if Dipyridamole can improve serum phosphate levels and reduce the need for phosphate supplementation.

Participants needed: 90
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Stanford UniversityUpdated: Jun 11, 2026Locations: 1
Eligibility criteria

Adult kidney transplant patients. [+1]

Contraindications to Dipyridamole. [+2]

Status: Not yet recruiting

The Adaptive Platform Trial for Kidney Disease

Background: Randomized clinical trials (RCTs) are essential for evaluating intervention effects but are often challenged by regulatory and logistical burdens, high costs, and extended timelines. To address these challenges, the 'Adaptive Platform Trial in Kidney Disease' (APT-KIDNEY) will establish an investigator-initiated platform trial built on a unified regulatory, contractual, and operational framework. The platform emphasizes adaptive, cost-efficient methodology, automated data capture via linkage to electronic health records and administrative registers, and stakeholder engagement. Objectives: The primary objective of APT-KIDNEY is to establish an adaptive platform trial for evaluation of multiple interventions in patients with advanced kidney disease as defined by an estimated glomerular filtration rate \< 30 ml/min/1.73 m2 or end-stage kidney disease (ESKD) on dialysis or conservative care. Study design: APT-KIDNEY is a pragmatic, randomized, embedded, multifactorial, adaptive platform trial with interventions organized into domains, emphasizing low-intervention comparisons. Domains may be open-label or blinded and will be able to use response-adaptive randomization, adaptive stopping and arm-dropping, and adaptive enrichment to enhance efficiency and relevance where applicable. Study population: Adults (≥18 years) with advanced kidney disease defined by eGFR \< 30 mL/min/1.73 m2 for ≥3 months or ESKD on hemo- or peritoneal dialysis who are eligible for ≥1 one domain. Key exclusions include inability to provide informed consent; domain-specific exclusions may apply, but eligibility cannot be broadened beyond the core protocol. Trial outcomes: Core outcomes will be all-cause mortality, major adverse cardiovascular events (nonfatal myocardial infarction, nonfatal ischemic stroke, or cardiovascular death), and health-related quality of life (EQ-5D-5L). Abbreviated methods: APT-KIDNEY will permit domains to use frequentist and/or Bayesian methods. Primary analyses will target prespecified primary estimands and be conducted using the full analysis set. Prespecified sensitivity analyses will assess robustness to alternative strategies for intercurrent events and missing data, including per-protocol and as-treated supportive analyses. Outcomes are analyzed with generalized linear/mixed models and time-to-event methods with covariate adjustment. Frequentist analyses will be fixed-sample or group-sequential; results will be reported with 95% CIs and p-values, and Bayesian analyses will report posterior effects with 95% credible intervals and posterior probabilities. Bayesian domains will primarily use neutral, mildly skeptical priors. Multiplicity will be controlled at the domain level by a prespecified hierarchy: primary comparisons will precede secondary outcomes. Advanced adaptive domains will be evaluated by simulation to quantify operating characteristics including, power and Type I error, and the impact of outcome delays and missing data. Perspectives: APT-KIDNEY will establish an enduring, investigator-led platform for pragmatic, embedded nephrology trials, reducing start-up time and administrative burden through a shared regulatory and operational framework. Using standardized core outcomes and automated follow-up via electronic health records and national registers, it will generate faster, comparable, practice-relevant evidence across multiple interventions.

Participants needed: 5,000
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Nicholas CarlsonUpdated: Jun 10, 2026
Eligibility criteria

Adults with age ≥18 years [+6]

Status: Not yet recruiting

Evolution of Physical Frailty and Patient-Reported Outcome Measures in Kidney Transplant Candidates: A Mixed-Methods Longitudinal Study Protocol

This study looks at how the physical and emotional health of people changes while they wait for a kidney transplant. Waiting for an organ can take a long time. During this period, some patients become "frail." This means they lose strength and are at a higher risk for health problems. The main goal is to follow these patients over time to better understand their needs. Researchers will use a mobile application to collect Patient-Reported Outcome Measures (PROMs) directly from patients about how they feel and their quality of life. The study will also include personal interviews to learn about the patients' experiences and any difficulties they face when using technology. The results of this study will help to: • Identify early which patients are losing strength or health. • Improve the support that nurses provide during the transplant waiting period. • Make sure that digital health tools are easy for everyone to use. In short, this work aims to help patients reach the day of their surgery in the best possible condition.

Participants needed: 150
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Hospital del MarUpdated: Jun 8, 2026Duration: 24 Months
Eligibility criteria

Patients aged 18 years or older. [+4]

Severe cognitive impairment or active psychiatric disorders that prevent the rel... [+3]

Status: Recruiting

Immunological Reset to Enable Access to Hla-compatible Kidney Transplantation in Highly Sensitized Patients (RESET)

The purpose of this clinical trial is to evaluate whether a temporary reprogramming of the immune system can help highly sensitized (hyperimmunized) patients with end-stage kidney disease safely receive a compatible kidney transplant. Patients who are highly sensitized have developed an extremely high level of antibodies against human leukocyte antigens (HLA), often due to previous transplants, pregnancies, or blood transfusions. This condition makes it nearly impossible for them to find a compatible organ donor, leaving them stuck on dialysis indefinitely. This study tests an innovative strategy using Autologous Hematopoietic Stem Cell Transplantation (AHSCT). The procedure involves an intensive conditioning regimen using a combination of medications (cyclophosphamide, thymoglobulin, and rituximab) to deeply clear out the patient's existing mature immune cells. This is followed by the reinfusion of the patient's own previously collected and purified blood stem cells (CD34+ cells) to rebuild the immune system from scratch. The investigators hypothesize that this procedure will eliminate the "immunological memory" cells responsible for producing the problematic anti-HLA antibodies, resetting the immune system to a "naive" or inactive state. This immune reset is expected to eliminate or significantly lower circulating HLA antibodies, creating a critical window of opportunity for these patients to successfully receive a compatible kidney transplant from the deceased-donor waiting list.

Participants needed: 10
Trial details
Phase: Phase 1, Phase 2Age: 18-60Biological sex: AllType: InterventionalSponsor: Hospital Universitari Vall d'Hebron Research InstituteUpdated: Jun 4, 2026Locations: 1
Eligibility criteria

Patients aged between 18 and 60 years. [+5]

Contraindications to the conditioning regimen medications (rituximab, cyclophosp... [+6]

Status: Not yet recruiting

Low- vs Standard-Dose TMP-SMX for Prevention of Pneumocystis Pneumonia After Kidney Transplantation

This study is a prospective randomized controlled trial designed to evaluate the efficacy and safety of low-dose versus standard-dose trimethoprim-sulfamethoxazole (TMP-SMX) for the prevention of Pneumocystis jirovecii pneumonia (PJP) in kidney transplant recipients. Participants will be randomly assigned to receive either low-dose or standard-dose TMP-SMX for 12 months after kidney transplantation. The primary outcome is the incidence of PJP during the prophylaxis period. Secondary outcomes include adverse events related to TMP-SMX, dose reduction or discontinuation rates, incidence and timing of PJP after discontinuation, and other post-transplant complications. Participants will be followed for a total of 24 months, including a 12-month prophylaxis period and an additional 12-month follow-up period after discontinuation. This study aims to provide evidence for optimizing prophylactic strategies against PJP in kidney transplant recipients.

Participants needed: 1,084
Trial details
Phase: Phase 4Age: 18-70Biological sex: AllType: InterventionalSponsor: Anhui Provincial HospitalUpdated: Jun 1, 2026
Eligibility criteria

Not listed

Status: Recruiting

Study to Evaluate the Safety and Efficacy of the GGTA1 KO Thymokidney in Patients With ESRD

The purpose of this study is to evaluate the safety and efficacy of the GGTA1 KO Thymokidney in patients with end-stage renal disease (ESRD) who are either not eligible for conventional allogeneic kidney transplantation (Group 1) or are on an Organ Procurement and Transplantation Network (OPTN) kidney transplant waitlist, but are more likely to die or go untransplanted within 5 years than receive a kidney transplant (Group 2). The study consists of xenotransplantation followed by a 24-week Post-transplant Follow-up Period (Part A) to evaluate the efficacy and safety objectives followed by a Long-term Follow-up Period (Part B) to evaluate participant survival, GGTA1 KO Thymokidney survival, and screening for zoonotic infections. Part B will continue for the lifetime of the participant or for 52 weeks following nephrectomy, if required.

Participants needed: 50
Trial details
Phase: Phase 1, Phase 2Age: 40-70Biological sex: AllType: InterventionalSponsor: United TherapeuticsUpdated: May 27, 2026Locations: 1
Eligibility criteria

Provide voluntarily informed consent to participate in the study and for lifetim... [+17]

Need for multiple organ transplants. [+17]

Status: Recruiting

TTV-based mAnagement Of Long-term ImmunosuppreSsion in Kidney Transplantation

Long-term outcomes in kidney transplantation remain a significant challenge, as complications such as donor-specific antibodies (DSA), antibody-mediated rejection, infections, and cancer increasingly threaten graft and patient survival over time. The development of non-invasive biomarkers to guide the management of therapeutic immunosuppression beyond the first year post-transplantation is therefore a crucial unmet need. Torque Teno Virus (TTV), a non-pathogenic virus with a high prevalence worldwide, has emerged as a promising biomarker in this context. Its replication inversely reflects immune control by T cells, correlating with the depth of therapeutic immunosuppression. Additionally, its slow replication kinetics make TTV DNAemia a useful marker for evaluating patient adherence to immunosuppressive treatments. The TAOIST study tests whether longitudinal monitoring of TTV DNAemia every six months, starting from the second year after transplantation, can guide the personalization of immunosuppressive therapy. The primary endpoint is the time to the first occurrence of complications linked to inadequate immunosuppression, including dnDSA, biopsy-proven rejection, infection, cancer, or graft loss. Secondary objectives include evaluating the acceptability of TTV DNAemia among healthcare professionals and assessing its cost-effectiveness compared to standard care. An ancillary objective examines the link between TTV DNAemia and the immunosuppressant possession ratio (IPR) to explore its potential as a marker of treatment adherence.

Participants needed: 600
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Hospices Civils de LyonUpdated: May 27, 2026Locations: 4
Eligibility criteria

Adult ≥ 18 years-old [+8]

Recipient of an HLA identical graft [+9]

Status: Not yet recruiting

Muscle Ultrasound for Sarcopenia Assessment in Kidney Transplant Recipients

This is a single-center prospective observational study designed to evaluate the effectiveness of multimodal muscle ultrasound for the assessment of sarcopenia in kidney transplant recipients. Adult patients undergoing kidney transplantation will undergo both muscle ultrasound and bioelectrical impedance analysis (BIA) at predefined time points before and after transplantation. The primary objective is to evaluate the diagnostic performance of muscle ultrasound for sarcopenia assessment, including its correlation and agreement with BIA-derived skeletal muscle index (BIA-SMI), as well as its diagnostic accuracy. Secondary objectives include describing the longitudinal changes in sarcopenia prevalence and muscle-related parameters from the pre-transplant period to 1 year after transplantation. The study aims to provide evidence for a convenient, noninvasive, radiation-free, and reliable method for sarcopenia assessment in kidney transplant recipients.

Participants needed: 140
Trial details
Age: 18-80Biological sex: AllType: ObservationalSponsor: Sichuan Provincial People's HospitalUpdated: May 26, 2026Locations: 1
Eligibility criteria

Adult patients aged 18 years or older [+3]

Patients with severe limb deformity or conditions preventing muscle ultrasound a... [+2]

Status: Recruiting

Kidney Transplant Improvement Through New Exercise Training to Increase Capacity

The goal of this clinical trial is to learn if a home-based exercise program can be safely and feasibly used to improve physical activity and physical function in adults waiting for a kidney transplant. The study will also learn how acceptable and useful this program is for participants. The main questions it aims to answer are: * Can a remote exercise program be delivered successfully to people on the kidney transplant waiting list? * Do participants follow the exercise program and wear a physical activity tracker as asked? * Is the program safe and well tolerated? Researchers will compare two groups to see if the exercise program leads to higher physical activity and better physical function: * Usual pre-transplant care with a physical activity tracker * Usual pre-transplant care plus an online exercise program Participants will: * Wear a wrist activity tracker to measure daily physical activity * Complete a one-week baseline period before being assigned to a study group * Be randomly assigned (like flipping a coin) to one of two groups * If assigned to the exercise group, take part in online exercise classes at home for 12 weeks with reminders and feedback, and then another 12 weeks without reminders and feedback * Answer questionnaires about their health, activity, and experience in the study This study may help researchers learn how to better support people waiting for kidney transplant through safe, home-based exercise programs.

Participants needed: 60
Trial details
Age: 60+Biological sex: AllType: InterventionalSponsor: University of PennsylvaniaUpdated: May 6, 2026Locations: 1
Eligibility criteria

be at least 60 years old [+8]

Have had a myocardial infarction or a stroke in the 3 months immediately prior t... [+4]

Status: Recruiting

Testing the Feasibility of a Self-Management Support Program for Patient With Chronic Diseases in Israel

This study explores an intervention to support people in Israel who are living with chronic health conditions such as cancer or after kidney transplantation. It focuses on a well-known international program called the Chronic Disease Self-Management Program (CDSMP), which was developed at Stanford University. The program helps individuals build confidence and skills to better manage their health, feel more in control, and improve their day-to-day quality of life. Participants will take part in a six-week group program, delivered online, where they will learn practical strategies for managing symptoms like fatigue or pain, setting achievable health goals, communicating effectively with healthcare professionals, and staying active and engaged. The sessions are guided by trained facilitators and include support from others facing similar health challenges. The study will involve surveys before and after the program, as well as a follow-up six months later, to understand how the program may have helped participants. Some participants will also be invited to share their experiences in small discussion groups. By testing this program in Israel, the researchers hope to learn how it can be adapted and offered more widely to help others living with chronic conditions.

Participants needed: 45
Trial details
Age: 21+Biological sex: AllType: InterventionalSponsor: University of HaifaUpdated: Apr 29, 2026Locations: 1
Eligibility criteria

Age 21 years or older [+3]

Documented cognitive impairment [+2]

Status: Recruiting

Eight-Treg Study:Trial of Adoptive Immunotherapy With Autologous ex Vivo Expanded Regulatory CD8+ T Cells in Living Donor Kidney Transplant Recipients

The only curative treatment for end-stage renal disease is through kidney transplantation. Solid organ transplants success had been made possible by the development of Immunosuppressive (IS) drugs. However, the long-term survival of transplants is still shortened by the chronic dysfunction of the graft which is not prevented by current IS regimens. Moreover, these IS drugs increase the risk of opportunistic infections and malignancies, and have many non-immune side-effects that hamper their tolerability. New research strategies are, therefore, developed with the aim of reducing the dependence on conventional pharmacological IS drugs. Regulatory cell therapy is one of these strategies. It consists of expanding specific populations of immune regulatory cells ex vivo into cell-based drugs that can then be infused into transplant recipients, with the goal of inducing graft tolerance. This is the framework of this clinical trial. The experimental drug "Eight Treg" being evaluated in this study is an autologous cell therapy product containing CD8+ regulatory T lymphocytes (Tregs) expanded ex vivo during 21 days of cell culture. Team 2 of the Center for Research in Transplantation and Translational Immunology (CR2TI), Nantes University, INSERM, Mixed Research Unit (UMR) 1064, responsible for developing the manufacturing process of the experimental drug "Eight Treg", has demonstrated the feasibility of the expansion of CD8+ Tregs ex vivo and their ability to prevent skin graft rejection and inhibit Graft Versus Host Disease (GVHD) in NOD-Scid-IL-2γ-/- mouse models (NSG)14. Based on the preclinical experience of CR2TI team 2, which has been working on basic and translational aspects of CD8+ Tregs for 15 years, the present phase I clinical trial aims to assess the safety of increasing doses of the experimental drug "Eight Treg" in 9 recipients of renal transplantation from a living donor. The possibility of manufacturing the experimental drug "Eight Treg" at the required doses, in accordance with the Good Manufacturing Process (GMP), has been assessed in validation runs as specified at the end of the "justification of the study" part of this protocol. This clinical trial will be the first administration of expanded CD8+ Tregs into humans, and it follows previous studies which evaluated the safety of other regulatory cell therapy products, containing expanded CD4+ Tregs and other regulatory cells (autologous tolerogenic dendritic cells performed by Nantes CHU laboratory and clinical services, for example), injected into patients in different contexts (renal transplantation, liver transplantation, GVHD, type 1 diabetes, etc) without causing any significant adverse effect. This study will pave the way for future, broader research on the use of CD8+ Tregs as a possible anti-rejection and tolerance inducer "drug" in transplantation.

Participants needed: 9
Trial details
Phase: Phase 1Age: 18-99Biological sex: AllType: InterventionalSponsor: Nantes University HospitalUpdated: Apr 29, 2026Locations: 1
Eligibility criteria

Man or woman with chronic renal failure requiring kidney transplantation and app... [+14]

Patient has previously received any tissue or organ transplant other than the pl... [+27]

Status: Recruiting

REgulatory T Cell Therapy to Achieve Immunosuppression REduction

The goal of this multi-national, multi-center, open-label, randomized Phase 2 trial is to determine the safety and efficacy of administering expanded regulatory T cells (TRK-001) to prevent allograft rejection in living donor renal transplant recipients. Enrolled subjects will be randomized to one of 2 study arms: Arm 1 subjects will receive standard of care immunosuppression Arm 2 subjects will receive initial standard of care (SOC) immunosuppression and a single infusion of TRK-001. Three months after the transplant, Arm 2 subjects may be able to begin reducing their immunosuppression medication to a 1-drug regimen. The primary outcome measures of trial are to evaluate several components indicating immunologic problems with the transplanted organ at 1-year post-transplant and to evaluate the ability for the study subjects given TRK-001 to wean to a 1-drug immunosuppression regimen. All enrolled subjects will be followed for 5 years post-transplant.

Participants needed: 34
Trial details
Phase: Phase 2Age: 18-65Biological sex: AllType: InterventionalSponsor: Singulera Therapeutics Inc.Updated: Apr 27, 2026Locations: 7
Eligibility criteria

Males or females aged 18-65 years as of the date of informed consent who will un... [+7]

Known sensitivity or contraindication to thymoglobulin, everolimus, sirolimus, o... [+33]

Status: Not yet recruiting

MRI Technical Development and Applications in Kidney Disease

Magnetic resonance imaging (MRI), as a non-invasive and non-contrast enhanced technique, has the potential to improve patient health care and management. The overall objective of proposed project is to: 1. develop, customize, and optimize anatomic and functional MRI methods, 2. explore the use of MRI methods to study CKD and evaluate post-transplant kidneys, and 3. investigate the potential of MRI in the diagnosis, prognosis, and monitoring of the progression of renal dysfunction. In addition to direct studies of the kidney, brain MRI studies will also be performed to identify the cerebrovascular and cognitive effects of chronic renal function deficiency and medical treatment (e.g. hemodialysis and immunosuppression). The brain and kidneys have similar vascular bed, and both are susceptible to vascular injury, which provides the pathological basis for the widely recognized association of reduced renal function with prevalent cerebrovascular diseases (CVDs) and cognitive impairment (CI). The MRI methods in the brain will be applied to explore the origins for widely observed CVDs and prevalent cognitive impairment (CI) in kidney disease patients.

Participants needed: 180
Trial details
Age: 18-70Biological sex: AllType: ObservationalSponsor: University of MinnesotaUpdated: Apr 13, 2026Locations: 1
Eligibility criteria

Ferromagnetic implants [+26]

Status: Recruiting

Shingrix in Renal Transplant Recipients

The goal of this clinical trial is to learn how well the shingles vaccine (Shingrix) works and how safe it is in adults with kidney failure who are waiting for a kidney transplant, including those who later receive a transplant. The study also aims to find out whether giving an extra (third) dose of the vaccine after transplant improves protection. The main questions it aims to answer are: How strong is the body's immune response to the vaccine at different time points (about 1 month, 2 years, and 3 years after vaccination) in people waiting for a kidney transplant? Does a third dose of the vaccine after transplant improve the immune response compared to not receiving a third dose? How long does protection from the vaccine last before and after transplant? How safe is the vaccine in this group, including whether it affects transplant-related immune markers? Researchers will compare people who receive a third dose of the vaccine after transplant to those who do not receive a third dose, as well as to results from similar groups studied in the past, to see if the extra dose improves immune protection. Participants will: Be screened to see if they can take part in the study Attend about 3 to 6 study visits over approximately 30 to 37 months Receive two doses of the shingles vaccine if they have not already been vaccinated, or complete study assessments if they were vaccinated before joining If they receive a kidney transplant during the study, be randomly assigned (by chance) to receive either a third dose of the vaccine or no additional dose Complete questionnaires, have physical exams if needed, and provide blood (and urine, if applicable) samples at study visits Take part in follow-up visits to check immune response and safety, with the option to allow samples to be stored for future research Shingrix is approved for adults aged 50 and older and for younger adults with weakened immune systems. However, giving a third dose after a kidney transplant is not standard practice and is being studied in this trial.

Participants needed: 132
Trial details
Phase: Phase 3Age: 18-70Biological sex: AllType: InterventionalSponsor: University of Colorado, DenverUpdated: Apr 8, 2026Locations: 4
Eligibility criteria

Not listed

Status: Recruiting

Study to Evaluate the Safety and Efficacy of the 10 GE Xenokidney in Patients With ESRD

The purpose of this study is to evaluate the safety and efficacy of the 10 GE Xenokidney in patients with ESRD who are either not eligible for conventional allogeneic kidney transplantation (Group 1) or are on an Organ Procurement and Transplantation Network (OPTN) kidney transplant waitlist, but are more likely to die or go untransplanted within 5 years than receive a kidney transplant (Group 2). The study consists of xenotransplantation followed by a 24-week Post-transplant Follow up Period (Part A) to evaluate the efficacy and safety objectives followed by a Long-term Follow-up Period (Part B) to evaluate participant survival, 10 GE Xenokidney survival, and screening for zoonotic infections. Part B will continue for the lifetime of the participant.

Participants needed: 50
Trial details
Phase: Phase 1, Phase 2Age: 40-70Biological sex: AllType: InterventionalSponsor: United TherapeuticsUpdated: Mar 27, 2026Locations: 2
Eligibility criteria

Provide voluntarily informed consent to participate in the study and for lifetim... [+16]

Need for multiple organ transplants. [+17]

Status: Recruiting

Reduced Immunosuppression in Older Renal Transplant Recipients With Trugraf®/TRAC Monitoring (RIOT Trial): A Prospective, Randomized, Multicenter Trial.

The purpose of this research is to determine the safety and efficacy of withdrawing MMF (Mycophenolate Mofetil) in kidney transplant recipients who are 55 years or older at the time of receiving a kidney transplant. We are comparing them to patients who receive the standard of care Mycophenolate Mofetil.

Participants needed: 350
Trial details
Phase: Phase 4Age: 55+Biological sex: AllType: InterventionalSponsor: Mayo ClinicUpdated: Mar 20, 2026Locations: 3
Eligibility criteria

Solitary kidney transplant recipient >55 years of age. At most 1 prior solitary... [+3]

The results of the most recent DSA testing indicate DSA with an MFI >2000. [+6]

Status: Recruiting

Impact of ExtraCorporeal Phototherapy (ECP) on Auxiliary Follicular T-lymphocytes and Circulating B-lymphocytes During Chronic AntiBody-Mediated Rejection in Kidney Transplantation.

Chronic AntiBody-Mediated Rejection (cABMR) is the leading cause of late kidney transplant loss (after 1 year of kidney transplantation). Its therapeutic management is poorly codified and there is currently no treatment referring. Extracorporeal phototherapy (ECP) is a therapeutic apheresis that involves purifying mononucleated cells in the blood, exposing them to UltraViolet A (UVA) and re-injecting them to the patient. This treatment is used as common care in the first line as part of the treatment of cutaneous T lymphoma and in the second line as part of the graft versus host reaction after bone marrow allograft. The mechanisms underlying the action of the ECP are not well known. They are mediated by the reinjection of cells exposed to UVA which enter apoptosis and induce immunomodulation. Recent work during cABMR shows that TFH lymphocytes, the maturing population of B lymphocytes, are deregulated and activated. The hypothesis is that ECP can modulate T Follicular Helper (TFH) lymphocytes during cABMR.

Participants needed: 30
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: University Hospital, AngersUpdated: Mar 6, 2026Locations: 4
Eligibility criteria

ECP treatment decision based on transplant team habits (care management) [+9]

Active infection or infection with hepatitis B, C or HIV virus [+5]

Status: Not yet recruiting

Kidney Transplant Immunosuppressive Therapy Adherence Trial (KITE)

This randomized controlled interventional study aims to evaluate the effect of structured education and telephone counseling on immunosuppressive medication adherence among kidney transplant recipients. Poor adherence to immunosuppressive therapy after kidney transplantation is a major risk factor for acute rejection, graft loss, and increased morbidity. Education and behavioral support interventions delivered by nurses may improve medication understanding, adherence behaviors, and self-management skills. In this trial, 60 participants will be randomly assigned to either an intervention group receiving individualized education, an immunosuppressive medication adherence booklet, and scheduled telephone counseling sessions, or a control group receiving routine clinical care. Adherence will be assessed using the Immunosuppressive Medication Adherence Scale and biological monitoring through tacrolimus level variability over 8 weeks. Additional outcomes include changes in medication knowledge scores based on pre-test and post-test assessments. The study will contribute evidence regarding whether nurse-led telephone counseling and structured education can enhance adherence, improve clinical follow-up, and support long-term graft success in kidney transplant patients.

Participants needed: 60
Trial details
Age: 18-70Biological sex: AllType: InterventionalSponsor: University of GaziantepUpdated: Jan 28, 2026Locations: 1
Eligibility criteria

Adult kidney transplant recipients aged 18 years or older [+5]

Under 18 years of age [+4]

Status: Not yet recruiting

Imlifidase for Highly Sensitized Kidney Transplant Recipients With a posItive crossmAtch Against a Deceased Donor: Results of Kidney Transplantations Performed in Accordance to the French Guidelines.

Imlifidase is a recombinant cysteine protease derived from Streptococcus pyogenes and produced in Escherichia coli, which has the ability to cleave and degrade all human IgGs. Four to six hours after imlifidase infusion, the entire IgG pool is degraded into F(ab')2 and Fc fragments. In vitro, imlifidase inhibits HLA antibody-mediated NK cell activation and antibody-dependent cell-mediated cytotoxicity. Imlifidase degrades also the IgG of the B cell Receptor (BCR), inhibiting BCR-mediated cell signal, transiently preventing memory B cell response to antigenic stimulation and their transition into antibody-producing cells. Two clinical studies have been designed to determine whether imlifidase could inactivate IgG donor-specific antibodies as a desensitization strategy in highly sensitized candidates for kidney transplantation. In the phase I/II study, 25 patients were transplanted in Sweden and United States. Among them, 18 had a positive flow cytometry crossmatch (FCXM) and 2 a positive complement-dependent cytotoxicity crossmatch (CDCXM). In the phase II study (Highdes Trial), 19 patients with an incompatible living or deceased donor from the United States, Sweden, and France were included. Among them, 7, 18, 2, and 8 had respectively a positive T-cell FCXM, positive B-cell FCXM, positive T-cell CDCXM, and positive B-cell CDCCXM. The primary efficacy endpoint was the ability of Imlifidase to convert a positive XM to a negative one. Conversion of baseline positive XM to negative within 24 h after Imlifidase treatment occurred in 89.5% (n=17) of the 19 patients. In the follow-up study including all the patients transplanted after Imlifidase desensitization, the antibody-mediated rejection rate (AMR) was at 39%, most of them occurring during the first month post-transplantation. Three-year death-censored graft survival was 93% in patients with AMR and 77% in the others. Three-year patient survival was 85% in patients with AMR and 94% in the others. No safety signal was reported. Based on these data, Imlifidase is now indicated as a desensitization agent of highly sensitized adult kidney transplant patients with positive crossmatch against an available ABO-compatible deceased donor. It should be reserved for patients unlikely to be transplanted under the available kidney allocation system including the prioritization program for highly sensitized patients (https://www.ema.europa.eu). Therefore, the French Society of Transplantation (SFT), the French-speaking Society of Nephrology, Dialysis and Transplantation (SFNDT) and the French Society of Histocompatibility and Immunogenetics (SFHI) have proposed French recommendations for patient selection, choice of antibodies characteristics, treatment and follow-up in order to homogenize practices. Although this new treatment addressed an unmet medical need, its authorization was based on only two small-scale studies. Therefore, additional data on long-term graft function and survival are required in patients treated by imlifidase.

Participants needed: 450
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: University Hospital, BordeauxUpdated: Feb 2, 2026Locations: 20Duration: 36 Months
Eligibility criteria

Highly sensitized adult kidney transplant candidates [+1]

Age < 18 years-old

Status: Not yet recruiting

Tubeless Spontaneous Ventilation Anesthesia in Kidney Transplantation

The aim of this clinical trial is to compare the intraoperative use of neuromuscular blocking agents and other anesthetic drugs between tubeless spontaneous ventilation anesthesia (TSVA) and conventional endotracheal intubation (ETT) anesthesia in kidney transplantation. The study will also evaluate the safety, stability, and postoperative recovery associated with TSVA. This trial is designed to address the following questions: * Does TSVA reduce the intraoperative requirement for neuromuscular blocking agents and other anesthetic medications? * Does TSVA improve postoperative outcomes in kidney transplant recipients? * How do the intraoperative safety and stability of TSVA compare with those of ETT anesthesia? Researchers will compare anesthetic drug consumption, intraoperative anesthetic performance, and postoperative recovery outcomes between the TSVA and ETT groups to determine whether TSVA can decrease anesthetic drug use and enhance patient recovery. Participants will: * Undergo a complete preoperative assessment * Receive kidney transplantation under TSVA or ETT anesthesia, with relevant intraoperative data recorded * Receive tubeless postoperative management, with documentation of pain scores, complications, and recovery of graft function * Be followed throughout their lifetime after discharge, providing long-term follow-up information

Participants needed: 60
Trial details
Age: 18-65Biological sex: AllType: InterventionalSponsor: Jianxing HeUpdated: Jan 29, 2026
Eligibility criteria

No gender restriction, age 18-65 years (including upper and lower limits). [+9]

Combined multi-organ transplantation. [+6]

Status: Recruiting

The Effects of Vonoprazan Fumarate on DGF Incidence in DD Kidney Transplant Recipients

This is an exploratory, multicenter, single-arm study designed to evaluate the efficacy of perioperative Vonoprazan Fumarate in reducing the incidence of Delayed Graft Function (DGF) in deceased-donor kidney transplant recipients. DGF is a common early complication that significantly impacts graft function and long-term transplant survival. This study aims to explore how Vonoprazan Fumarate, a potassium-competitive acid blocker (P-CAB), can potentially improve macrophage phagocytic function, reduce kidney inflammation, and enhance early kidney function recovery. Patients aged 18 years and older who are undergoing first-time deceased-donor kidney transplantation will be enrolled. Vonoprazan Fumarate will be administered daily starting on the day of transplantation and continuing for seven days post-surgery. The primary endpoint is DGF incidence, while secondary endpoints include kidney function recovery, serum creatinine reduction, estimated glomerular filtration rate, and safety assessments. Adverse events will be monitored, and the study will also explore potential biomarkers for inflammation and graft function. The study is expected to provide insights into a potential new therapeutic strategy to reduce DGF and improve early kidney transplant outcomes, potentially benefiting future kidney transplant patients by offering a safer and more effective perioperative treatment option.

Participants needed: 47
Trial details
Phase: Phase 1, Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: First Affiliated Hospital of Chongqing Medical UniversityUpdated: Dec 23, 2025Locations: 2
Eligibility criteria

Age ≥ 18 years at time of transplantation. [+5]

Receiving a living-donor kidney transplant or multi-organ transplantation. [+9]

Status: Not yet recruiting

Salivary Replication of BK Virus in Post-kidney Transplant

BK virus infection in kidney transplantation can compromise graft function. Current data suggest that BK virus nephropathy results not only from transmission of virus from the donor but also from reactivation of latent virus in the recipient. However, no study has investigated the possibility of respiratory transmission. This study would provide a better understanding of the pathophysiology of BK virus infection in kidney transplant recipients. The investigators would study viral replication of BK virus in saliva, urine and blood of patients who received a kidney transplant at the Amiens University Hospital. For this, the investigators will collect salivary self-collection on the day of the kidney transplant then at 1, 3, 6, 9 and 12 months as well as a urine and blood sample. The investigators will measure BK viral load in these three samples at different times.

Participants needed: 100
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Centre Hospitalier Universitaire, AmiensUpdated: Dec 8, 2025Locations: 1
Eligibility criteria

kidney transplant recipients [+1]

age < 18 years [+1]

Status: Not yet recruiting

A Qualitative Study on Gratitude and Recognition Toward Living Kidney Donors

Kidney transplantation is widely recognized as the best treatment for patients with end-stage renal disease. However, its development is limited by the persistent shortage of available organs. Living donor kidney transplantation offers the best functional and survival outcomes, yet the number of procedures remains insufficient. Living kidney donation relies on a voluntary and altruistic act by a healthy individual who accepts surgery without direct medical benefit. This act of generosity raises important questions regarding how society acknowledges and values such commitment. The lack of formal recognition may contribute to the psychological burden experienced by some donors and may not adequately reflect the gratitude of the medical community and society toward them. This study aims to explore the perceptions of living kidney donors regarding the potential implementation of a symbolic form of recognition (for instance, a commemorative medal) offered after donation. The hypothesis is that such recognition could improve donors' post-donation experience and strengthen the societal value associated with living organ donation, while fully respecting ethical principles prohibiting any financial reward. This is a qualitative, monocentric study based on semi-structured interviews with individuals who have donated a kidney. The interviews will focus on donors' motivations, their personal experience of donation, and their opinions about different possible forms of post-donation recognition. Interviews will be recorded, transcribed verbatim, and analyzed using inductive thematic analysis to identify recurring themes and perspectives. The main endpoint is the identification of thematic categories related to donors' perception of post-donation recognition and its potential impact on their experience. Secondary objectives include exploring donors' expectations regarding societal gratitude, their views on the symbolic value of such recognition, and the potential influence on future donor engagement. The findings of this study are expected to contribute to the ethical reflection surrounding the acknowledgment of living donors, support initiatives promoting non-financial recognition, and help develop respectful and meaningful ways of expressing societal gratitude toward those who make the gift of life possible.

Participants needed: 15
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Assistance Publique - Hôpitaux de ParisUpdated: Nov 28, 2025
Eligibility criteria

Individuals who have donated a kidney at Hôpital Saint-Louis between January 1,... [+2]

Refusal or opposition to participate in the study. [+4]

Status: Not yet recruiting

CMV-associated Immunomodulation in Renal Transplant Patients

Cytomegalovirus (CMV) infection has been associated with an increased risk of bacterial, fungal and viral infections in solid organ transplant recipients. The purpose of this study to evaluate if the occurrence of CMV viremia modify the ability to develop optimal immune responses against other pathogens in kidney transplant recipients (heterologous immunity). The objective of this project is to identify the immune pathways affected by CMV in the context of immunosuppression associated with kidney transplantation.

Participants needed: 60
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Assistance Publique - Hôpitaux de ParisUpdated: Sep 12, 2025Locations: 4
Eligibility criteria

Age > 18 years [+3]

Patients with an active viral (other than CMV), bacterial or fungal infection at... [+1]