Actively Recruiting
Immunological Reset to Allow Access to HLA Compatible Transplantation in Highly Sensitized Kidney Transplant Candidates Through Non-myeloablative Autologous Stemm Cell Transplantation
Led by Hospital Universitari Vall d'Hebron Research Institute · Updated on 2025-02-12
10
Participants Needed
1
Research Sites
138 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a study for hypersensitized patients who have been waiting for more than 3 years for an offer for a kidney transplant. The objective is to perform a transplant of autologous hematopoietic precursors with the aim of producing what we call an immunological reset to make the maximum number of anti-HLA antibodies disappear and thus increase the chances of the patient receiving an offer for a kidney transplant.
CONDITIONS
Official 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
- Women and men aged 18 to 65 years
- Diagnosed with chronic kidney disease and currently on dialysis
- On the waiting list for kidney transplant from a deceased donor with no compatible offer received in the last 3 years
- cPRA greater than 97% and prioritized in the transplant program for over 3 years
- Positive IgG serologies for Cytomegalovirus and Epstein Barr
- Women of childbearing potential must have a negative pregnancy test at entry and agree to use safe contraception 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, hepatitis C, zoster, or active tuberculosis
- Serious uncontrolled major organ disease
- Infection requiring hospitalization or intravenous antibiotics within 4 weeks prior to screening or oral antibiotics within 2 weeks prior
- Primary or secondary immunodeficiencies
- History of malignancy within 5 years 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 reactions to human 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
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Trial Site Locations
Total: 1 location
1
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Actively Recruiting
Research Team
O
Oriol Bestard, MD, PhD
CONTACT
D
Delphine Kervella, MD, PhD
CONTACT
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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