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

Last updated: February 10, 2025
Sponsor: Hospital Universitari Vall d'Hebron Research Institute
Overall Status: Active - Recruiting

Phase

N/A

Condition

Kidney Disease

Focal Segmental Glomerulosclerosis

Treatment

hematopoietic precursor transplantation (TPHa)

Clinical Study ID

NCT06809075
RESET
2023-506478-11-01
  • Ages 18-65
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 withdialysis.

  4. Patient who is on the waiting list for kidney transplant from a death donor and whohas not received an offer for a compatible transplant in the last 3 years within thenational PATHI prioritization program.

  5. cPRA calculated of more than 97% and having been in the program of prioritizationfor 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 tothe study and must agree to use safe contraceptive methods according to theguideline CTFG recommendations on contraception in clinical trials during durationof the study (condoms are considered safe methods male and female, oralcontraceptives, etc.).

  8. Patients vaccinated against tetanus, influenza, pneumococcus and herpes zoster

Exclusion

Exclusion Criteria:

  1. Current known infection, recurrent bacteria, virus, fungus or fungus bacteria, orother 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 withantibiotics during the 4 weeks prior to screening, or oral treatment withantibiotics the previous 2 weeks.

  4. Patients with primary or secondary immunodeficiencies.

  5. Patient with an active history of tuberculosis (even if treated) or patients withuntreated latent tuberculosis.

  6. Malignancy during the 5 years prior to screening, except for carcinoma of the basalcell 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) duringthe 4 weeks prior to screening.

  10. Severe allergic or anaphylactic reactions to human monoclonal antibodies, humanizedor murine.

  11. Treatment with any investigational agent during the 4 weeks (or 5 half-lives of theinvestigational drug, whichever is longer) prior to screening.

  12. Immunization with live vaccine during the 2 months prior to screening.

  13. Pregnant or breastfeeding women.

Study Design

Total Participants: 10
Treatment Group(s): 1
Primary Treatment: hematopoietic precursor transplantation (TPHa)
Phase:
Study Start date:
April 05, 2024
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035
    Spain

    Active - Recruiting

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