In short
There are currently 3 clinical trials underway across Europe exploring new treatments for transplant rejection, specifically focusing on antibody-mediated rejection in kidney transplant recipients. These studies are testing innovative therapies including immunomodulators and cell-based treatments to help prevent or treat the immune system's attack on transplanted kidneys.
Clinical trial locations
- Austria
- Belgium
- Czechia
- France
- Study on Allogeneic Umbilical Cord Mesenchymal Stromal Cells for Treating Chronic Kidney Transplant Rejection in Adult Patients
- Study on Efgartigimod for Patients with Antibody-Mediated Rejection after Kidney Transplant
- Study on Riliprubart for Preventing and Treating Antibody-Mediated Rejection in Adult Kidney Transplant Patients
- Germany
- Italy
- Spain
- Sweden
Study on Efgartigimod for Patients with Antibody-Mediated Rejection after Kidney Transplant
This trial is testing Efgartigimod, a treatment designed to help manage antibody-mediated rejection in people who have received a kidney transplant. The medication works by reducing the activity of certain antibodies that cause the body's immune system to attack the transplanted kidney.
Who can participate:
- Adults between 18 and 80 years old
- People who had a kidney transplant at least 6 months ago
- Those diagnosed with active or chronic active antibody-mediated rejection with detectable donor-specific antibodies
- Patients already taking specific medications like mycophenolate mofetil for at least 20 weeks and on stable doses of mycophenolate mofetil and tacrolimus for at least 4 weeks
- Patients on tacrolimus doses between 5 to 10 ng/mL for at least 4 weeks
- Those on steroid doses between 0 to 10 mg per day of prednisone for at least 4 weeks
Who cannot participate:
- Patients not diagnosed with antibody-mediated rejection
- Those outside the specified age range
Participants will receive Efgartigimod through injections under the skin using a pre-filled syringe. Throughout the study, they will be monitored with regular check-ups, laboratory tests, and measurements of vital signs to assess the treatment's safety and effectiveness. The study aims to evaluate whether Efgartigimod can help reduce rejection and improve outcomes for kidney transplant recipients.
Study on Allogeneic Umbilical Cord Mesenchymal Stromal Cells for Treating Chronic Kidney Transplant Rejection in Adult Patients
This French study is exploring a unique approach using allogeneic umbilical cord mesenchymal stromal cells to treat chronic kidney transplant rejection. These special cells, derived from umbilical cords, are believed to have properties that can reduce inflammation and promote healing in the body.
Who can participate:
- Adults aged 18 years or older
- Those who had a kidney transplant between 1 and 10 years ago
- Patients with chronic humoral rejection diagnosed through kidney biopsy within the last 6 months
- Those with donor-specific anti-HLA antibodies with a measurement below 20,000
- Patients who did not respond to 3 monthly courses of IV-IG treatment
- Those with kidney function greater than 30 milliliters per minute
- Patients with high levels of protein in their urine
- Those able to attend follow-up consultations and affiliated with a social security system
Who cannot participate:
- Patients without a diagnosis of chronic humoral rejection
- Those who have not undergone a kidney biopsy
- Patients who have not received conventional IV-IG treatment
- Non-adult patients
The treatment involves receiving these cells through an intravenous infusion directly into the bloodstream. Participants will be monitored for four hours after each infusion and will attend regular follow-up visits over 24 months to assess kidney function and overall health. The study compares results with those of patients receiving a placebo to determine if this cell therapy can improve outcomes for patients with chronic rejection.
Study on Riliprubart for Preventing and Treating Antibody-Mediated Rejection in Adult Kidney Transplant Patients
This trial is investigating BIVV020, also known as Riliprubart, as a treatment to both prevent and treat antibody-mediated rejection in adult kidney transplant patients. The study includes two different groups of participants with different needs.
Who can participate:
- Participants receiving standard care therapy as determined by their doctor
- Cohort A: Adults with chronic kidney disease scheduled to receive a kidney transplant from either a living or deceased donor
- Cohort B: Kidney transplant recipients diagnosed with active antibody-mediated rejection
- Those with a Body Mass Index of 40 kg/m2 or less
- Women and men willing to use contraceptives during treatment and for at least 49 weeks after the last dose
Who cannot participate:
- Patients who have had a recent organ transplant and are experiencing rejection
- Those outside the specified age range
- Patients not part of the specified clinical trial groups
- Those considered part of a vulnerable population
BIVV020 is given as an injection under the skin. One group receives the medication to prevent rejection from occurring, while the other group receives it to treat active rejection. Throughout the study, participants undergo regular monitoring including laboratory tests to measure kidney function, such as estimated glomerular filtration rate and protein-to-creatinine ratio. The study, estimated to conclude by December 2026, will assess the medication's effectiveness, safety, and how the body processes it.
Summary
All three clinical trials focus specifically on antibody-mediated rejection in kidney transplant recipients, highlighting this as a key challenge in transplant medicine. The studies are concentrated in Western European countries, with France hosting all three trials, followed by Germany and Spain with two trials each. This geographical distribution reflects the strong research infrastructure and expertise in transplant medicine in these regions.
The trials represent different therapeutic approaches: two studies are testing medications that target the immune system's antibodies (Efgartigimod and BIVV020), while one explores regenerative medicine using special cells from umbilical cords. Notably, the BIVV020 study is unique in examining both prevention and treatment of rejection, while the other two focus on treating existing rejection. All trials emphasize the importance of careful patient monitoring and require participants to have received their transplant at least 6 months to a year ago, ensuring the transplant is stable before experimental treatments begin.
