Immune Reset to Enable Kidney Transplant for Highly Sensitized Patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a two-phase, open-label pilot study evaluating autologous hematopoietic stem cell transplantation (AHSCT) to reset the immune system in adults with end-stage kidney disease who have very high anti-HLA antibodies. Participants undergo non-myeloablative lymphodepletion, collect and purify CD34+ cells, then reinfuse them to potentially permit deceased-donor kidney transplantation. The trial will monitor safety, feasibility, immune reconstitution, and anti-HLA responses over 12 months in Phase 1 and expand to assess efficacy and safety in Phase 2 with additional participants. All participants proceed to standard transplant care if crossmatch testing confirms compatibility after AHSCT. This is a single-center, non-randomized study designed to inform future strategies for highly sensitized patients on the transplant waiting list.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients aged between 18 and 60 years.
* Diagnosis of end-stage kidney disease (ESRD) currently maintained on chronic dialysis.
* Highly sensitized/hyperimmunized status, defined by a high calculated Panel Reactive Antibody (cPRA) level (e.g., \>= 95%).
* Active status on the deceased-donor kidney transplant waiting list.
* Adequate bone marrow, hepatic, cardiac, and pulmonary function to safely undergo the conditioning regimen and AHSCT.
* Capable of understanding the study requirements and providing written informed consent.

Exclusion Criteria:

* Contraindications to the conditioning regimen medications (rituximab, cyclophosphamide, or rATG).
* Active, uncontrolled systemic infection, or chronic active infection (including HIV, active Hepatitis B or C, or active tuberculosis).
* Significant cardiac dysfunction (e.g., Left Ventricular Ejection Fraction \< 50%) or severe underlying pulmonary disease.
* History of malignant neoplasm within the past 5 years, excluding successfully treated non-melanoma skin cancer or carcinoma in situ.
* Previous autologous or allogeneic hematopoietic stem cell transplantation.
* Pregnancy or breastfeeding.
* Any psychiatric, medical, or geographical condition that, in the investigator's opinion, prevents compliance with the protocol and long-term follow-up.

Where it's running

• Hospital Universitari Vall d'Hebron
  Barcelona, Catalonia, Spain Recruiting

Study contacts

• Principal investigator: Oriol Bestard — Hospital Vall d'Hebron
• Study coordinator: Oriol Bestard, Nephrologist
• Email: oriol.bestard@vallhebron.cat
• Phone: 34932607400

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.