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

Sponsor
Hospital Universitari Vall d'Hebron Research Institute
Study ID
NCT06809075
Status
Recruiting
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Conditions

  • Kidney Disease
  • Kidney Transplant
  • Kidney Transplant Candidates

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • hematopoietic precursor transplantation (TPHa) — PROCEDURE
    An apheresis is performed on the patients and a selection of CD34 hematopoietic progenitors is performed. Subsequently, conditioning is performed with cyclophosphamide, thymoglobulin, corticosteroids and rituximab to subsequently infuse the hematopoietic precursors.

Study Details

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.

Key Dates

First listed
Feb 5, 2025
Start date
Apr 5, 2024
Status verified
Feb 2025
Primary completion
Dec 1, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: hypersensitive patients undergoing aHSCT
    hypersensitive patients undergoing aHSCT. All patients in this study participate in this arm.

Primary Outcome Measure

To evaluate the impact of autologous hematopoietic stem cell transplantation (aHSCT) [ Time Frame: from enrolment to 12 months post-TPHa ]

Central Contacts

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