Ongoing Clinical Trials for Kidney Transplant Rejection
There are currently 6 clinical trials investigating new treatments to prevent or manage kidney transplant rejection. These studies are evaluating medications such as imlifidase, felzartamab, and tegoprubart across multiple European countries, focusing on highly sensitized patients and long-term transplant outcomes.
Clinical trial locations
- Austria
- Belgium
- Czechia
- Espagne
- Finland
- France
- Long-Term Follow-Up Study of Imlifidase in Highly Sensitized Kidney Transplant Patients
- Study of Felzartamab for Patients with Late Antibody-Mediated Rejection After Kidney Transplant
- Study on Imlifidase and Drug Combination for Kidney Transplant in Highly Sensitized Children
- Study on Imlifidase for Highly Sensitized Patients with End-Stage Chronic Kidney Disease Awaiting Transplant
- Study on Long-Term Safety of Tegoprubart and Tacrolimus for Preventing Kidney Transplant Rejection in Patients
- Study on Tegoprubart for Preventing Kidney Transplant Rejection in Patients
- Germany
- Study of Felzartamab for Patients with Late Antibody-Mediated Rejection After Kidney Transplant
- Study on Imlifidase for Highly Sensitized Patients with End-Stage Chronic Kidney Disease Awaiting Transplant
- Study on Long-Term Safety of Tegoprubart and Tacrolimus for Preventing Kidney Transplant Rejection in Patients
- Study on Tegoprubart for Preventing Kidney Transplant Rejection in Patients
- Italy
- Netherlands
- Slovenia
- Spain
- Long-Term Follow-Up Study of Imlifidase in Highly Sensitized Kidney Transplant Patients
- Study of Felzartamab for Patients with Late Antibody-Mediated Rejection After Kidney Transplant
- Study on Imlifidase and Drug Combination for Kidney Transplant in Highly Sensitized Children
- Study on Imlifidase for Highly Sensitized Patients with End-Stage Chronic Kidney Disease Awaiting Transplant
- Study on Long-Term Safety of Tegoprubart and Tacrolimus for Preventing Kidney Transplant Rejection in Patients
- Study on Tegoprubart for Preventing Kidney Transplant Rejection in Patients
- Sweden
Long-Term Follow-Up Study of Imlifidase in Highly Sensitized Kidney Transplant Patients
This trial focuses on monitoring the long-term health outcomes of patients who have received a kidney transplant and were previously treated with imlifidase, a medication designed to help highly sensitized patients by reducing antibodies that can cause complications.
Who can participate: Patients must have previously participated in the clinical trial 20-HmedIdeS-19 and received a kidney transplant in that study. They need to have signed an informed consent form and be willing to follow all study procedures. Both male and female participants are eligible, including those from vulnerable populations.
Who cannot participate: Patients who have already received a kidney transplant after being treated with imlifidase are excluded, as are those who received a compatible kidney transplant without needing imlifidase.
What the study involves: The trial evaluates long-term outcomes up to five years after transplantation. The main focus is on monitoring graft failure-free survival, meaning whether the transplanted kidney continues to function without failure. Researchers will also assess kidney function through tests like estimated glomerular filtration rate, patient survival rates, and overall quality of life. Regular follow-up visits will include health assessments and monitoring for any side effects related to the treatment.
Investigational drug: Imlifidase is administered through an intravenous infusion and works by breaking down antibodies that can cause the body to reject a transplanted kidney, improving the chances of transplant success in highly sensitized patients.
Study of Felzartamab for Patients with Late Antibody-Mediated Rejection After Kidney Transplant
This study investigates felzartamab as a treatment for antibody-mediated rejection, a condition where the immune system attacks the transplanted kidney even long after the transplant has been performed.
Who can participate: Eligible participants are between 18 and 74 years old with a confirmed diagnosis of active or chronic active antibody-mediated rejection based on a recent kidney biopsy. They must have received their kidney transplant at least six months before joining the study, have good venous access, test positive for donor-specific antibodies, and maintain adequate kidney function. Participants must be up to date with vaccinations and agree to use effective birth control methods during the study.
Who cannot participate: Patients who have not received a kidney transplant, do not have late antibody-mediated rejection, or do not meet the specific diagnosis criteria cannot participate.
What the study involves: This is a double-blind study where participants will be randomly assigned to receive either felzartamab or a placebo through intravenous infusion. The treatment phase lasts up to 12 months, with regular monitoring visits to track kidney function, vital signs, and overall health. A mid-study evaluation at approximately 24 weeks may include a kidney biopsy, followed by a comprehensive final evaluation at the end of the study period.
Investigational drug: Felzartamab is an immunosuppressive agent that works by targeting and reducing the activity of specific immune cells responsible for attacking the transplanted kidney.
Study on Imlifidase and Drug Combination for Kidney Transplant in Highly Sensitized Children
This trial aims to help children who are highly sensitized and face difficulty finding a compatible kidney donor due to their strong immune reaction against potential donors.
Who can participate: Children aged 1 to 17 years with end-stage renal disease who are waiting for a kidney transplant from a living or deceased donor can participate. They must be highly sensitized with a panel reactive antibodies level of 80% or higher and have a positive crossmatch test. Participants must have previously tried desensitization treatments without success or have an antibody status that is too difficult for successful desensitization. Signed informed consent from parents or guardians is required.
Who cannot participate: Children who are not highly sensitized, do not have a positive crossmatch, or are outside the specified age range cannot participate.
What the study involves: The study tests whether imlifidase can convert a positive crossmatch test to negative within 24 hours, allowing the child to receive a kidney transplant. Children will receive imlifidase through intravenous infusion, along with other medications such as methylprednisolone and rituximab. The trial will monitor kidney function and overall health for up to five years after transplant, tracking graft survival, patient well-being, and any complications.
Investigational drug: Imlifidase breaks down antibodies in the immune system that cause the body to reject a new kidney, reducing immune reactions and making transplantation possible for highly sensitized children.
Study on Imlifidase for Highly Sensitized Patients with End-Stage Chronic Kidney Disease Awaiting Transplant
This trial investigates the use of imlifidase to temporarily remove antibodies that make it difficult for highly sensitized patients to find a compatible kidney donor, enabling transplantation from a deceased donor.
Who can participate: Eligible participants are between 18 and 75 years old with end-stage renal disease and a panel reactive antibody level of 50% or higher. They must be active on the kidney transplant waiting list, have an ABO-compatible deceased donor aged 10 to 70 years, and have a positive crossmatch test indicating the presence of donor-specific antibodies. Participants must have been transplanted in Europe after January 2010 and be included in the CTS registry.
Who cannot participate: Patients who are not on the kidney transplant list, are not highly sensitized, do not have end-stage chronic kidney disease, or cannot be pre-treated with imlifidase are excluded.
What the study involves: Participants will receive imlifidase through intravenous infusion before transplant. Within 24 hours, a crossmatch test will confirm whether antibodies have been effectively reduced. Once the test is negative, the kidney transplant from a deceased donor will proceed. The study follows participants for one year after transplant with regular monitoring of kidney function, patient survival, and any adverse events.
Investigational drug: Imlifidase temporarily breaks down antibodies that cause rejection, improving the chances of the body accepting the transplanted kidney from a deceased donor.
Study on Long-Term Safety of Tegoprubart and Tacrolimus for Preventing Kidney Transplant Rejection in Patients
This trial evaluates the long-term safety and effectiveness of tegoprubart in preventing the body from rejecting a transplanted kidney over an extended period.
Who can participate: Participants must have successfully completed a previous related study and be willing to sign informed consent. They must agree not to join another treatment study while participating. Women must either be unable to have children due to surgery or be at least two years past menopause, or if of childbearing potential, have a negative pregnancy test and agree to use very effective birth control. Men must also agree to use effective birth control and not donate sperm for 120 days after the last dose.
Who cannot participate: Specific exclusion criteria are not detailed in the provided information beyond the requirement to have completed a prior study.
What the study involves: Participants will receive tegoprubart intravenously at a dose of 20 mg/kg, along with either mycophenolate mofetil or mycophenolate sodium. The study monitors participants over a long period, with regular assessments of kidney function, vital signs, and side effects at baseline and at 12, 24, 36, and 48 months. The trial is expected to conclude by February 2030.
Investigational drugs: Tegoprubart is an immunosuppressant being studied for its ability to modulate the immune response and prevent rejection. Mycophenolate mofetil and mycophenolate sodium are medications that suppress the immune system to help prevent rejection of the transplanted kidney.
Study on Tegoprubart for Preventing Kidney Transplant Rejection in Patients
This study compares the safety and effectiveness of tegoprubart with tacrolimus, a commonly used medication to prevent rejection in patients undergoing their first kidney transplant.
Who can participate: Participants must be at least 18 years old and receiving their first kidney transplant from a living or deceased donor. They need to be willing to follow study rules and not join another treatment study. Women must be unable to have children, past menopause, or use very effective birth control if of childbearing potential. Men must use effective birth control and not donate sperm for 120 days after the last dose.
Who cannot participate: Specific exclusion criteria are not detailed in the provided information.
What the study involves: The trial lasts up to 12 months and evaluates kidney function at 12 months post-transplant, specifically measuring estimated glomerular filtration rate. Participants will receive either tegoprubart or tacrolimus, along with standard medications like mycophenolate mofetil and prednisolone. Regular check-ups will monitor kidney function, graft survival, patient survival, and the rate of new-onset diabetes after transplant. A placebo group is included for comparison.
Investigational drugs: Tegoprubart is an immunosuppressant being studied to modulate the immune response and maintain kidney function. Tacrolimus is a well-established medication that suppresses the immune system by inhibiting proteins crucial for activating immune cells, reducing the risk of rejection.
Summary
The six ongoing clinical trials for kidney transplant rejection demonstrate a significant focus on highly sensitized patients, who face particular challenges in finding compatible donors. Four trials investigate imlifidase, highlighting this medication’s central role in current research for enabling transplantation in difficult cases. Three of these imlifidase studies are conducted across multiple European countries, with Spain, France, Sweden, and Austria being particularly active in this research area.
Notable trends include attention to special populations, with one trial specifically dedicated to pediatric patients aged 1 to 17 years. Long-term follow-up is emphasized in several studies, with monitoring periods extending up to five years after transplant to assess sustained effectiveness and safety. Two trials investigate tegoprubart, a newer immunosuppressant, comparing it with established treatments like tacrolimus, suggesting efforts to develop alternative therapeutic options.
One study addresses late antibody-mediated rejection with felzartamab, targeting a specific complication that can occur long after transplantation. France stands out as the most represented country, participating in all six trials, followed by Spain and Germany. The geographic distribution reflects strong collaborative research networks across European transplantation centers working to improve outcomes for patients facing kidney transplant rejection.
