Actively Recruiting
Immunological Reset to Allow Access to HLA Compatible Transplantation in Highly Sensitized Kidney Transplant Candidates Through Non-myeloablative Autologous Stem Cell Transplantation
Led by Hospital Universitari Vall d'Hebron Research Institute · Updated on 2025-02-12
10
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying a treatment for hypersensitized patients who have been waiting over three years for a kidney transplant offer. The goal is to perform an autologous hematopoietic precursor transplant to reset the immune system, aiming to eliminate anti-HLA antibodies and improve the chances of receiving a compatible kidney transplant. This trial is sponsored by the Hospital Universitari Vall d'Hebron Research Institute and focuses on patients aged 18 to 65 with chronic kidney disease on dialysis. Participants receive a procedure called hematopoietic precursor transplantation, which involves collecting specific stem cells from their blood after an apheresis. Before reinfusion, patients undergo conditioning treatment using drugs including cyclophosphamide, thymoglobulin, corticosteroids, and rituximab. All enrolled patients undergo this procedure as part of a single study arm, with no placebo or comparator group. During the study, patients are monitored from enrollment through 12 months after the transplant procedure. Researchers evaluate the reduction of HLA antibodies, transplantation success, immune cell changes, and possible adverse reactions or infections. Participants undergo regular assessments to track antibody levels, immune function, and transplant outcomes. The study lasts approximately one year post-transplant to assess safety and effectiveness of the immunological reset.
CONDITIONS
Brief Title
Immunological Reset to Allow Access to HLA Compatible Transplantation in Highly Sensitized Kidney Transplant Candidates Through Non-myeloablative Autologous Stemm Cell Transplantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and provide written consent
- Age between 18 and 65 years
- Chronic kidney disease patients on dialysis
- On the waiting list for kidney transplant from a deceased donor without a compatible offer in the last 3 years
- Calculated panel reactive antibody (cPRA) above 97% and in prioritization program for over 3 years
- Positive IgG serology for Cytomegalovirus and Epstein Barr
- Women of childbearing potential must have a negative pregnancy test and agree to use recommended contraceptive methods during the study
- Vaccinated against tetanus, influenza, pneumococcus, and herpes zoster
You will not qualify if you...
- Current or recurrent infections including HIV, hepatitis B or C, zoster, or tuberculosis (active or untreated latent)
- Serious uncontrolled major organ disease
- Infection requiring hospitalization and intravenous antibiotics within 4 weeks or oral antibiotics within 2 weeks prior to screening
- Primary or secondary immunodeficiencies
- Malignancy within 5 years prior to screening except certain skin cancers properly removed
- Known abuse of alcohol, drugs, or chemicals within 1 year prior to screening
- Complicated peripheral venous access
- Neutropenia or thrombocytopenia within 4 weeks prior to screening
- Severe allergic or anaphylactic reactions to monoclonal antibodies
- Treatment with investigational agents within 4 weeks or 5 half-lives prior to screening
- Immunization with live vaccines within 2 months prior to screening
- Pregnant or breastfeeding women
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 12 months post-transplantation
Participants undergo autologous hematopoietic stem cell transplantation involving apheresis, conditioning with medications, and infusion of hematopoietic precursors.
Multiple visits for transplantation procedures and monitoring during treatment period
Duration - Up to 12 months after treatment or kidney transplant
Participants are monitored for immune response, adverse reactions, infection incidence, and kidney transplant outcomes for up to 12 months after transplantation or kidney transplant.
Regular visits for assessment and monitoring during follow-up period
Trial Site Locations
Total: 1 location
1
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Actively Recruiting
Research Team
O
Oriol Bestard, MD, PhD
D
Delphine Kervella, MD, PhD
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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