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

NCT ID: NCT06809075

Last Updated: 2025-02-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-05
• Study Completion Date: 2026-12-31

Brief 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.

Conditions

Kidney Disease; Kidney Transplant; Kidney Transplant Candidates

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

hypersensitive patients undergoing aHSCT

hypersensitive patients undergoing aHSCT. All patients in this study participate in this arm.

Group Type: EXPERIMENTAL

hematopoietic precursor transplantation (TPHa)

Intervention Type: 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.

Interventions

hematopoietic precursor transplantation (TPHa)

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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitari Vall d'Hebron Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital Universitari Vall d'Hebron

Barcelona, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Oriol Bestard, MD, PhD

Role: CONTACT

oriol.betsard@vallhebron.cat

932746000 ext. 4661

Delphine Kervella, MD, PhD

Role: CONTACT

delphine.kervella@vallhebron.cat

932746000 ext. 4661

Facility Contacts

Oriol Bestard, MD, PhD

Role: primary

oriol.bestard@vallhebron.cat

932746000

Other Identifiers

2023-506478-11-01

Identifier Type: CTIS

Identifier Source: secondary_id

RESET

Identifier Type: -

Identifier Source: org_study_id