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Ongoing Clinical Trials for Kidney Transplant Patients

Currently, there are 40 ongoing clinical trials investigating various treatments and approaches to improve outcomes for kidney transplant patients. These studies examine immunosuppressive medications, infection prevention strategies, organ rejection management, and long-term kidney function preservation across multiple countries in Europe.

Clinical trial locations

Comparison of Tacrolimus alone versus Tacrolimus, Mycophenolate mofetil and Prednisone combination in elderly kidney transplant patients to reduce infections

This study focuses on elderly patients who have received a kidney transplant in the Netherlands. The main goal is to determine whether using tacrolimus alone is more effective than the standard treatment combining tacrolimus, mycophenolate mofetil, and prednisone in reducing infections during the first three years after transplantation.

Main inclusion criteria: Participants must be 60 years of age or older and receiving either a deceased donor or living donor kidney transplant. They must not have donor-specific anti-HLA antibodies at the time of transplantation. Previous kidney transplant recipients can participate if they meet all other criteria.

Main exclusion criteria: Patients below 18 or above 65 years of age cannot participate. Those with active or chronic infections, current pregnancy or breastfeeding, known allergies to immunosuppressive medications, severe heart, liver, or lung disease, active cancer or history of cancer in the past 5 years, uncontrolled diabetes, mental conditions affecting ability to follow study procedures, or participation in other clinical trials within the past 30 days are excluded.

Purpose and focus: The study will monitor participants for three years, tracking the occurrence of infections, kidney function, and overall quality of life. Regular medical tests will check kidney performance and track any complications that may occur. The research aims to determine if using fewer medications can reduce infection risk while maintaining adequate protection against organ rejection.

Investigational medications: Tacrolimus is an immunosuppressive medication that helps prevent organ rejection by weakening the immune system’s response. The standard triple therapy includes tacrolimus combined with mycophenolate mofetil and prednisone, which work together to suppress the immune system through different mechanisms.

Study of Ravulizumab to Prevent Delayed Graft Function in Adult Patients After Kidney Transplant

This international study across Spain, Italy, Poland, Austria, Germany, Portugal, and Czechia investigates whether ravulizumab can reduce the severity of delayed graft function in adults receiving kidneys from deceased donors who are at high risk for this complication.

Main inclusion criteria: Participants must be at least 18 years old with end-stage kidney disease requiring dialysis. They must be receiving a kidney from either a donation after circulatory death donor or a high-risk donation after brain death donor.

Main exclusion criteria: Age below 18 or above 65 years, previous organ transplant recipients, living donor kidney transplant recipients, known allergies to ravulizumab, active infections or serious medical conditions, pregnant or breastfeeding women, participation in another clinical trial within the past 30 days, history of serious adverse reactions to similar medications, significant kidney disease other than the condition leading to transplant, uncontrolled high blood pressure, history of blood clotting disorders, active cancer or history within the past 5 years, and severe liver or heart disease are all exclusion criteria.

Purpose and focus: The study tracks how quickly patients can stop requiring dialysis after transplant and monitors kidney function over a 90-day period. Researchers will measure kidney function through blood tests and examine kidney tissue samples to assess treatment effectiveness.

Investigational medication: Ravulizumab is given through intravenous infusion to help prevent delayed graft function by targeting part of the immune system to protect the newly transplanted kidney. The goal is to reduce the need for dialysis after transplantation and help the new kidney start working more quickly.

Study of Tocilizumab Treatment for Chronic Antibody-Mediated Rejection in Kidney Transplant Recipients

This study in Spain and Sweden examines whether adding tocilizumab to standard care treatment can help preserve kidney function in transplant recipients experiencing chronic active antibody-mediated rejection, a condition where the immune system creates antibodies that attack the transplanted kidney.

Main inclusion criteria: Participants must be at least one year post-transplant with confirmed active antibody-mediated rejection proven by tissue examination. They must have a kidney function test showing at least 20 ml/min/1.73 m² within the past month and be EBV positive. For women who can become pregnant, a negative pregnancy test and effective birth control are required.

Main exclusion criteria: Age below 18 years, pregnant or breastfeeding women, history of organ transplant rejection within the last 3 months, active or chronic infections including tuberculosis, hepatitis B, hepatitis C, or HIV, severe liver disease or abnormal liver function tests, uncontrolled high blood pressure, history of cancer in the past 5 years, major surgery planned within the next 6 months, current participation in other clinical trials, serious heart conditions or recent heart attack, severe blood disorders, mental health conditions interfering with study procedures, known allergic reactions to study medications, and substance abuse or addiction are excluded.

Purpose and focus: Participants will receive tocilizumab as a subcutaneous injection for 24 months. The study will monitor kidney function regularly through blood tests, kidney biopsies at 12 and 24 months, and additional tests measuring protein levels in urine and antibody levels. Follow-up will continue for 36 months to assess long-term outcomes.

Investigational medication: Tocilizumab works by blocking a specific protein in the immune system to reduce inflammation and prevent organ rejection. Standard of care includes the current established treatment commonly used to prevent and treat organ rejection.

Study on Dulaglutide for Preventing Diabetes in Patients with Metabolic Syndrome Awaiting Kidney Transplantation

This Spanish study investigates whether dulaglutide can reverse metabolic syndrome in patients on the waiting list for kidney transplantation. Metabolic syndrome is a group of conditions including high blood sugar, excess body fat around the waist, and abnormal cholesterol levels that increase the risk of heart disease, stroke, and type 2 diabetes.

Main inclusion criteria: Patients must be on the kidney transplant waiting list, over 18 years old, and have metabolic syndrome defined by having 3 or more of these conditions: prediabetes, obesity with BMI of 27 or higher, high triglycerides of 150 mg/dL or higher, or large waist circumference greater than 101.6 cm for men or 88.9 cm for women. Women of childbearing potential must use effective contraception.

Main exclusion criteria: Patients without metabolic syndrome, not on the kidney transplantation waiting list, not meeting at least two criteria for metabolic syndrome, unwilling or unable to follow treatment for 3 to 6 months, or part of a vulnerable population cannot participate.

Purpose and focus: The study lasts up to six months, with evaluations at three and six months to assess improvements in metabolic syndrome. Researchers will monitor blood sugar levels, body weight, insulin sensitivity, and side effects throughout the study period.

Investigational medication: GLP-1 receptor agonists are administered via injection and work by mimicking a hormone that stimulates insulin release, helping lower blood sugar. The study tests whether these medications can improve metabolic health before transplantation.

Study on How Pantoprazole Affects the Absorption of Mycophenolate Mofetil in Post-Transplant Patients

This Dutch study examines how taking pantoprazole, a proton pump inhibitor that reduces stomach acid, affects the absorption of mycophenolate mofetil in organ transplant patients. The research compares generic and brand-name versions to determine if they are bioequivalent when taken with pantoprazole.

Main inclusion criteria: Participants must be healthy male volunteers between 18 and 55 years old with body weight over 50 kg and BMI between 18.5 and 30 kg/m2. They must have normal vital signs including systolic blood pressure between 90-149 mmHg, diastolic blood pressure between 50-89 mmHg, and heart rate between 50-90 beats per minute. Normal laboratory test results for blood and urine are required, and participants must be able to understand the study and provide written informed consent.

Main exclusion criteria: Non-post-transplantation recipients, females, individuals under 18 or over 65 years old, and vulnerable populations cannot participate.

Purpose and focus: The study monitors how pantoprazole affects mycophenolate mofetil absorption by measuring drug concentrations in blood over time. This information could help improve medication management in post-transplant care.

Investigational medications: Proton pump inhibitors reduce stomach acid and are studied to see how they affect mycophenolate mofetil absorption. Mycophenolate mofetil prevents organ rejection by suppressing the immune system, and the study compares original and generic versions when taken with PPIs.

Study on How Tacrolimus Monohydrate and Mycophenolate Mofetil Affect Gut Bacteria in Patients with Chronic Kidney Disease After Transplant

This Belgian study investigates how tacrolimus and mycophenolate mofetil interact with gut microbiota and how these interactions affect medication processing in kidney transplant patients with chronic kidney disease.

Main inclusion criteria: Patients must have chronic renal failure with planned kidney transplantation from a living donor, be between 18 and 75 years old with BMI between 18 and 35 kg/m², receiving care at Cliniques universitaires Saint-Luc, and be on treatment combining tacrolimus and mycophenolate mofetil.

Main exclusion criteria: Patients with chronic renal failure cannot participate.

Purpose and focus: The study monitors how medications are absorbed and metabolized, focusing on variability influenced by gut bacteria changes after transplantation. Regular drug level monitoring will help understand medication processing differences among patients.

Investigational medications: Tacrolimus prevents organ rejection by suppressing the immune system through inhibiting calcineurin. Mycophenolate mofetil also prevents rejection by weakening the immune system through inhibiting inosine monophosphate dehydrogenase, an enzyme crucial for immune cell proliferation.

Study on Immune System Suppression Using Donor Modified Immune Cells (MIC) for Patients Undergoing Living Donor Kidney Transplantation

This German study tests a new treatment using donor modified immune cells prepared in a laboratory to help manage the immune response after kidney transplantation from living donors. The treatment is given through intravenous injection and compared with standard care.

Main inclusion criteria: Donors must be at least 18 years old and able to give consent. Patients must have chronic kidney disease stage 5 preparing for living donor kidney transplant, be between 18 and 74 years old, have compatible blood type with donor, be receiving their first kidney transplant, have low levels of antibodies (less than 20%), have no specific antibodies against donor tissue, have negative CDC crossmatch and COVID-19 PCR test, and provide written informed consent. Female patients of childbearing potential must have negative pregnancy test and use effective contraception.

Main exclusion criteria: Patients not undergoing living donor kidney transplantation, not within specified age range, not in specified clinical trial groups, and vulnerable populations cannot participate.

Purpose and focus: The study monitors kidney transplant health, rejection signs, infections, and overall well-being over 367 days. The primary endpoint evaluates absence of acute rejection, graft loss, or dysfunction. The goal is to determine if MIC treatment can achieve operational tolerance, reducing the need for standard immunosuppressive therapy.

Investigational medication: MIC uses special immune cells modified to help the body accept the new kidney without causing rejection. The treatment is delivered through IV infusion to achieve operational tolerance and reduce standard immunosuppression needs.

Study on Optimal Dose of Rabbit Anti-Human T-Lymphocyte Immunoglobulin and Mycophenolic Acid for Kidney Transplant Patients with Low Immunological Risk

This French study determines the best dose of Grafalon (rabbit anti-human T-lymphocyte immunoglobulin) for preventing complications related to CD4 T cell lymphopenia in low-risk kidney transplant patients, while maintaining effective immunosuppression.

Main inclusion criteria: Patients must be 18 years or older receiving their first kidney transplant.

Main exclusion criteria: Patients who have had renal transplant, those with renal insufficiency, age below 18 or above 65 years, pregnant or breastfeeding women, history of organ transplant rejection within last 3 months, active or chronic infections, severe liver disease, uncontrolled high blood pressure, history of cancer in past 5 years, major surgery planned within 6 months, current participation in other trials, serious heart conditions, severe blood disorders, mental health conditions interfering with study procedures, known allergic reactions to study medications, immunosuppressive therapy differing from standard treatment, and substance abuse are excluded.

Purpose and focus: The treatment involves antithymocyte immunoglobulin administered through intravenous infusion for a short period. The primary outcome measures relative depletion of T cells by more than 30% at day 4. Follow-up includes regular assessments of immune cell counts, kidney function, and potential infections or cardiovascular events for up to one year.

Investigational medication: Grafalon helps prevent complications after kidney transplant by targeting specific immune cells called T-lymphocytes to reduce rejection risk without causing prolonged low immune cell levels.

Study on Preventing Rejection in Kidney Transplant Patients Using Rabbit Anti-Human Thymocyte Immunoglobulin and Basiliximab

This French study compares Thymoglobuline (containing rabbit anti-human thymocyte immunoglobulin) with Simulect (containing basiliximab) to determine which is more effective in preventing acute rejection during the first year after kidney transplantation.

Main inclusion criteria: Patients aged between 18 and 79 years old with at least one anti-HLA antibody identified by Luminex Single Antigen test with MFI greater than or equal to 2000, graft incompatibility rate less than 85%, ability to understand study nature and requirements, written informed consent obtained, and coverage by social security.

Main exclusion criteria: Previous kidney transplant recipients, patients with pre-existing DSAs, those not in specified age range, not part of specified clinical trial group, and vulnerable populations are excluded.

Purpose and focus: Participants are randomly assigned to receive either rATG or basiliximab through intravenous administration. Regular follow-up visits assess kidney function, check for new antibodies, and monitor for biopsy-proven acute rejection. Long-term evaluation continues for up to 3 years, assessing incidence of BPAR, death, graft loss, and conducting health and economic evaluations.

Investigational medications: rATG helps prevent rejection by reducing immune system activity through targeting lymphocytes. Basiliximab prevents rejection by blocking specific signals in the immune system that can lead to organ attack, often used in combination with other medications.

Study on Reducing or Stopping Immunosuppression with Tacrolimus and Ciclosporin in Patients with Late Kidney Transplant Failure

This Spanish study investigates whether continuing or stopping immunosuppressants (tacrolimus and cyclosporin) after six months affects HLA sensitization levels in patients experiencing late kidney graft failure.

Main inclusion criteria: Patients must provide written informed consent, be older than 18 years, have had at least one previous kidney transplant lasting at least 3 months, be on dialysis (hemodialysis or peritoneal dialysis) for maximum 6 months at study entry, have continuous immunosuppressive treatment with calcineurin inhibitors and steroids since restarting dialysis, be on waiting list or candidate for deceased donor kidney transplant relisting, be taking tacrolimus or cyclosporine, and have cPRA of 90% or less at study entry.

Main exclusion criteria: Patients who have not experienced renal transplantation or late renal graft failure, not within specified age range, or part of vulnerable population cannot participate.

Purpose and focus: Participants are randomly assigned to either continue or stop immunosuppressant medication after six months. The 24-month study monitors HLA sensitization degree and overall health through regular assessments to determine if stopping immunosuppressants is safe without increasing body reaction risk against kidney transplant.

Investigational medication: Immunosuppressants lower the immune response to prevent attacking transplanted kidney. The study compares continuing versus stopping these medications to assess effects on antibody development against transplanted organ.

Study on Reducing Tacrolimus in Kidney Transplant Patients with Low Immunological Risk Using Tacrolimus, Mycophenolic Acid, and Prednisone

This international study across Spain, Norway, and France investigates whether reducing tacrolimus dosage can maintain kidney function while minimizing side effects in low-risk kidney transplant patients over 18 months.

Main inclusion criteria: Participants must be adults treated with tacrolimus and MMF/MPS with or without corticosteroid, have had first kidney transplantation from living, brain dead, or deceased donor (Maastricht 3), be ABO blood group compatible with donor, be one year post-transplantation (between 350 and 515 days), have cPRA or TGI less than 20% on transplantation day with no DSA with MFI less than 500 before transplant and at one-year inclusion, have normal or IFTA 1-2 histology on one-year surveillance biopsy, be insured under health insurance scheme, and if of childbearing age, use effective contraception throughout entire study period.

Main exclusion criteria: Patients who have not had kidney transplant, not within specified age range including young adults and middle-aged adults, or part of vulnerable population cannot participate.

Purpose and focus: The study involves regular follow-up visits over 18 months monitoring kidney function and overall health. Regular blood tests measure tacrolimus levels and adjust dosage accordingly. Quality of life assessments occur at start and at 3, 6, 9, 12, 15, and 18 months. Final evaluation at 18 months assesses kidney function compared to initial assessments.

Investigational medication: Tacrolimus helps prevent organ rejection by suppressing immune system. The study examines how reducing tacrolimus amount affects kidney function while possibly reducing side effects associated with the drug.

Summary

The 40 ongoing clinical trials for kidney transplant patients span multiple European countries, with notable concentrations in Spain, France, Germany, and the Netherlands. These studies reflect diverse research priorities in transplant medicine, from optimizing immunosuppression strategies to preventing infections and managing rejection.

A significant focus across multiple trials involves refining immunosuppressive therapy. Several studies investigate whether reducing medication dosages or switching between different immunosuppressants can maintain transplant success while reducing side effects. This includes comparisons between tacrolimus monotherapy and combination approaches, as well as switching from calcineurin inhibitors to belatacept in various patient populations.

Prevention of delayed graft function and infection management represent major research themes. Studies examine medications like ravulizumab for improving initial kidney function, while others investigate CMV and BK virus prevention strategies. Special attention is given to vulnerable populations, including elderly patients, children, and adolescents, with several trials specifically designed for these age groups.

Several trials explore novel approaches such as using donor modified immune cells, regulatory T cell therapy, and precision medicine through genetic testing to optimize tacrolimus dosing. Additionally, studies investigate cardiovascular and metabolic complications common in transplant recipients, including trials examining medications like dapagliflozin, empagliflozin, eplerenone, and valsartan for preserving kidney function and managing cardiovascular risk.

The research landscape demonstrates a shift toward personalized medicine, with multiple studies using biomarkers and genetic information to guide treatment decisions. This comprehensive research effort aims to improve long-term outcomes, reduce complications, and enhance quality of life for kidney transplant recipients across different risk categories and age groups.

Ongoing Clinical Trials on Renal transplant

  • A Study of Felzartamab for Kidney Transplant Patients with Late Isolated Microvascular Inflammation

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    Austria Czechia France Germany Spain

  • Safety Study of Regulatory T Cells (Treg02) in Patients After Kidney Transplant

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    Germany

  • Study on Preventing CMV Infection in Low-Risk Kidney Transplant Patients Using Ganciclovir and Valganciclovir

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    Spain

  • Study of Belatacept versus Tacrolimus in Kidney Transplant Recipients with Subclinical Antibody Mediated Rejection

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    France

  • Study of Ravulizumab to Prevent Delayed Graft Function in Adult Patients After Kidney Transplant

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    Austria Czechia France Germany Italy Poland +2

  • Study on Mannitol and Normal Saline for Patients with End-Stage Renal Disease Undergoing Kidney Transplantation

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    Finland

  • Study on the Safety of Eight Treg and Drug Combination for Patients with Chronic Kidney Failure Undergoing Transplant from a Living Donor

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    France

  • Study on Eplerenone for Improving Kidney Function in Patients Undergoing Kidney Transplantation

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    France

  • Study on Optimal Dose of Rabbit Anti-Human T-Lymphocyte Immunoglobulin and Mycophenolic Acid for Kidney Transplant Patients with Low Immunological Risk

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    France

  • Study of Tocilizumab Treatment for Chronic Antibody-Mediated Rejection in Kidney Transplant Recipients

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    Spain Sweden

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