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โ† Trials
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Immunological Reset to Enable Access to Hla-compatible Kidney Transplantation in Highly Sensitized Patients (RESET)

RecruitingPhase 1, Phase 2Ages 18 Years - 60 YearsAllHospital Universitari Vall d'Hebron Research Instโ€ฆ
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In plain words

What the trial is, and whether it could suit you

The purpose of this clinical trial is to evaluate whether a temporary reprogramming of the immune system can help highly sensitized (hyperimmunized) patients with end-stage kidney disease safely receive a compatible kidney transplant. Patients who are highly sensitized have developed an extremely high level of antibodies against human leukocyte antigens (HLA), often due to previous transplants, pregnancies, or blood transfusions. This condition makes it nearly impossible for them to find a compatible organ donor, leaving them stuck on dialysis indefinitely. This study tests an innovative strategy using Autologous Hematopoietic Stem Cell Transplantation (AHSCT). The procedure involves an intensive conditioning regimen using a combination of medications (cyclophosphamide, thymoglobulin, and rituximab) to deeply clear out the patient's existing mature immune cells. This is followed by the

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๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • Autologous Hematopoietic Stem Cell Transplantation
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Where

1 site
Hospital Universitari Vall d'Hebron
Barcelona, Spain
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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