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New treatment option for Kidney Failure, Chronic
Official title Immunological Reset to Enable Access to Hla-compatible Kidney Transplantation in Highly Sensitized Patients (RESET)
ClinicalTrials.gov ID: NCT07607197
What this study is testing
What is Autologous Hematopoietic Stem Cell Transplantation?
Autologous Hematopoietic Stem Cell Transplantation is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for kidney failure, chronic.
Also referred to as AHSCT, Autologous CD34+ stem cell infusion.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Barcelona, Catalonia, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Barcelona, Catalonia, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.