Immunological Reset to Allow Access to HLA Compatible Transplantation in Highly Sensitized Kidney Transplant Candidates Through Non-myeloablative Autologous Stemm Cell Transplantation

Launched by HOSPITAL UNIVERSITARI VALL D'HEBRON RESEARCH INSTITUTE · Feb 4, 2025

Keywords

ClinConnect Summary

This clinical trial is designed for patients with chronic kidney disease who have been waiting for over three years for a compatible kidney transplant. The main goal is to help these patients by undergoing a special treatment that aims to reset their immune system. This treatment involves using their own blood cells to reduce harmful antibodies that can make it difficult to find a suitable donor kidney. By doing this, the hope is to increase their chances of receiving a kidney transplant.

To be eligible for this trial, participants must be between 18 and 65 years old, currently on dialysis, and have been on the transplant waiting list without an offer for a compatible kidney for at least three years. They should also have a very high level of sensitization to donor tissues and have specific positive blood tests. Participants will need to be able to understand the study and provide written consent. Throughout the trial, they can expect close monitoring and support to ensure their safety. This study is important because it offers a new opportunity for patients who have been struggling to find a suitable kidney donor.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. The patient must be able to understand and give written consent.
• • 2. Women and men between 18 and 65 years old.
• • 3. Patients with chronic kidney disease who are on renal therapy replacement with dialysis.
• • 4. Patient who is on the waiting list for kidney transplant from a death donor and who has not received an offer for a compatible transplant in the last 3 years within the national PATHI prioritization program.
• • 5. cPRA calculated of more than 97% and having been in the program of prioritization for more than 3 years
• • 6. Positive IgG serologies for Cytomegalovirus and Epstein Barr.
• • 7. Women of childbearing potential must have a negative pregnancy test upon entry to the study and must agree to use safe contraceptive methods according to the guideline CTFG recommendations on contraception in clinical trials during duration of the study (condoms are considered safe methods male and female, oral contraceptives, etc.).
• • 8. Patients vaccinated against tetanus, influenza, pneumococcus and herpes zoster
• Exclusion Criteria:
• • 1. Current known infection, recurrent bacteria, virus, fungus or fungus bacteria, or other infections (such as HIV, hepatitis B, hepatitis C, or zoster).
• • 2. Concomitant serious uncontrolled major organ disease.
• • 3. Any infection that requires hospitalization and intravenous treatment with antibiotics during the 4 weeks prior to screening, or oral treatment with antibiotics the previous 2 weeks.
• • 4. Patients with primary or secondary immunodeficiencies.
• • 5. Patient with an active history of tuberculosis (even if treated) or patients with untreated latent tuberculosis.
• • 6. Malignancy during the 5 years prior to screening, except for carcinoma of the basal cell or squamous cell carcinoma properly removed.
• • 7. Known abuse of alcohol, drugs or chemicals within 1 year prior to screening.
• • 8. Patients with complicated peripheral venous access
• • 9. Neutropenia (ANC \<1000/uL) or thrombocytopenia (platelet count \<100,000/uL) during the 4 weeks prior to screening.
• • 10. Severe allergic or anaphylactic reactions to human monoclonal antibodies, humanized or murine.
• • 11. Treatment with any investigational agent during the 4 weeks (or 5 half-lives of the investigational drug, whichever is longer) prior to screening.
• • 12. Immunization with live vaccine during the 2 months prior to screening.
• • 13. Pregnant or breastfeeding women.