Actively Recruiting
Immune Reset to Allow Access to HLA-compatible Kidney Transplantation in Highly Sensitized Patients
Led by Hospital Universitari Vall d'Hebron Research Institute · Updated on 2026-06-04
10
Participants Needed
1
Research Sites
56 weeks
Total Duration
On this page
Sponsors
H
Hospital Universitari Vall d'Hebron Research Institute
Lead Sponsor
H
Hospital Clinic of Barcelona
Collaborating Sponsor
AI-Summary
What this Trial Is About
This trial investigates whether resetting the immune system can help highly sensitized patients with end-stage kidney disease safely receive a compatible kidney transplant. These patients have high antibody levels against donor organs, often due to previous transplants, pregnancies, or blood transfusions, making it very hard to find a matching donor and keeping them on dialysis long-term. The study aims to test a new approach using Autologous Hematopoietic Stem Cell Transplantation (AHSCT) to reduce these antibodies and improve transplant chances. Participants undergo a treatment involving intense immune cell depletion using medications including rituximab, cyclophosphamide (adjusted for kidney disease), and thymoglobulin. After this conditioning, their own purified blood stem cells (CD34+ cells) are collected and reinfused to rebuild the immune system. The process includes stem cell collection through leukapheresis followed by reinfusion, with a planned reactivation on the kidney transplant waiting list six months after AHSCT. The study has two phases: initial safety testing with 4 patients followed by an efficacy and safety assessment with 6 more patients. Throughout the study, participants will be closely monitored for safety and immune system changes over 12 months. Blood and bone marrow samples will be collected to assess immune memory and antibody levels. Researchers will track changes in sensitization, successful kidney transplantation rates, and adverse events. Transplant recipients will receive standard immunosuppressive care. The trial duration includes a six-month wait before relisting for transplant and a full year of follow-up after AHSCT.
CONDITIONS
Brief Title
Immunological Reset to Enable Access to Hla-compatible Kidney Transplantation in Highly Sensitized Patients (RESET)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged between 18 and 60 years
- Diagnosis of end-stage kidney disease on chronic dialysis
- Highly sensitized status with high calculated Panel Reactive Antibody (cPRA) level (e.g., ≥ 95%)
- Active status on the deceased-donor kidney transplant waiting list
- Adequate bone marrow, liver, heart, and lung function to safely undergo treatment
- Able to understand study requirements and provide informed consent
You will not qualify if you...
- Contraindications to rituximab, cyclophosphamide, or thymoglobulin
- Active or uncontrolled systemic infection, including HIV, active Hepatitis B or C, or tuberculosis
- Significant heart dysfunction (e.g., ejection fraction below 50%) or severe lung disease
- History of cancer within past 5 years, except certain skin cancers
- Previous hematopoietic stem cell transplantation
- Pregnancy or breastfeeding
- Psychiatric, medical, or geographic conditions preventing protocol compliance and follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to several weeks during initial treatment phase
Participants undergo a non-myeloablative conditioning regimen including intravenous Rituximab, Cyclophosphamide, and Thymoglobulin, followed by peripheral blood stem cell collection, CD34+ selection, and reinfusion of purified autologous hematopoietic progenitor cells.
Multiple visits (in-person) for conditioning, stem cell collection, and reinfusion
Duration - Up to 12 months post-treatment
Participants are monitored for safety and immunological effects for up to 12 months post-treatment, with reactivation on the deceased-donor kidney transplant waiting list at 6 months for eligible participants.
Regular follow-up visits for safety and immunological monitoring during 12 months
Trial Site Locations
Total: 1 location
1
Hospital Universitari Vall d'Hebron
Barcelona, Catalonia, Spain, 08035
Actively Recruiting
Research Team
O
Oriol Bestard, Nephrologist
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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