RecruitingNot Applicable

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

Spain10 participantsStarted 2024-04-05

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. The patient must be able to understand and give written consent.
✓. Women and men between 18 and 65 years old.
✓. Patients with chronic kidney disease who are on renal therapy replacement with dialysis.
✓. 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.
✓. cPRA calculated of more than 97% and having been in the program of prioritization for more than 3 years
✓. Positive IgG serologies for Cytomegalovirus and Epstein Barr.
✓. 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.).
✓. Patients vaccinated against tetanus, influenza, pneumococcus and herpes zoster

Exclusion criteria

What they're measuring

To evaluate the impact of autologous hematopoietic stem cell transplantation (aHSCT)

Timeframe: from enrolment to 12 months post-TPHa

Proportion of patients achieving all of the following items at 6 months post-aHSCT or at the time of kidney transplant, if a compatible offer is received

Timeframe: from enrolment to 12 months post-aHSCT

Trial details

NCT IDNCT06809075

SponsorHospital Universitari Vall d'Hebron Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-01

Contact for this trial

Oriol Bestard, MD, PhD

932746000 oriol.betsard@vallhebron.cat

View on ClinicalTrials.gov More Kidney Disease trials