NCT07607197RecruitingPhase 1/2
Immunological Reset to Enable Access to Hla-compatible Kidney Transplantation in Highly Sensitized Patients (RESET)
Immune Reset to Allow Access to Hla-compatible Kidney Transplantation in Hyperimmunized Patients
Source: ClinicalTrials.gov · Last updated 4 Jun 2026
Brief summary (registry, in English)
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 reinfusion of the patient's own previously collected and purified blood stem cells (CD34+ cells) to rebuild the immune system from scratch. The investigators hypothesize that this procedure will eliminate the "immunological memory" cells responsible for producing the problematic anti-HLA antibodies, resetting the immune system to a "naive" or inactive state. This immune reset is expected to eliminate or significantly lower circulating HLA antibodies, creating a critical window of opportunity for these patients to successfully receive a compatible kidney transplant from the deceased-donor waiting list.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 19 May 2026
- Start date
- 1 Feb 2024
- Primary completion date
- 31 May 2027
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research Institute
- Diseases
- Chronic kidney disease
- NCT number
- NCT07607197
- EU CT number
- 2023-506478-11-01
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 10
- From 1 Feb 2024 to the primary completion date, 31 May 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Contraindications to the conditioning regimen medications (rituximab, cyclophosphamide, or rATG).
- Previous autologous or allogeneic hematopoietic stem cell transplantation.
Other illness
- Active, uncontrolled systemic infection, or chronic active infection (including HIV, active Hepatitis B or C, or active tuberculosis).
- History of malignant neoplasm within the past 5 years, excluding successfully treated non-melanoma skin cancer or carcinoma in situ.
- Any psychiatric, medical, or geographical condition that, in the investigator's opinion, prevents compliance with the protocol and long-term follow-up.
Lab values
- Significant cardiac dysfunction (e.g., Left Ventricular Ejection Fraction \< 50%) or severe underlying pulmonary disease.
Other
- Pregnancy or breastfeeding.
Who the study is looking for
- 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.
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fir Huvh Fundacio Institut De Recerca Hospital Universitari Vall De Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.