Immunological reset to help highly sensitized kidney transplant candidates receive transplants

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

This study is testing a new treatment to help people who have been waiting a long time for a kidney transplant because of high sensitization levels, to see if it can make it easier for them to get a compatible kidney.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Hospital Universitari Vall d'Hebron Research Institute (Academic / other)
• Locations: 1 site (Barcelona)
• Trial ID: NCT06809075 on ClinicalTrials.gov

What this trial studies

This study focuses on patients who have been waiting over three years for a kidney transplant due to high sensitization levels. It aims to perform a non-myeloablative autologous stem cell transplantation to achieve an immunological reset, reducing anti-HLA antibodies and increasing the likelihood of receiving a compatible kidney transplant. The intervention involves the transplantation of hematopoietic precursors to enhance transplant eligibility for these patients. The study is particularly relevant for those with chronic kidney disease on dialysis and high calculated panel reactive antibodies (cPRA).

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 with chronic kidney disease on dialysis and a cPRA of over 97% who have been on the transplant waiting list for more than three years.

Not a fit: Patients who do not meet the criteria for high sensitization or those who have received a compatible transplant offer in the last three years may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly increase the chances of kidney transplant for highly sensitized patients who have limited options.

How similar studies have performed: While the approach of immunological reset through stem cell transplantation is innovative, similar studies have shown promise in improving transplant eligibility for sensitized patients.

Eligibility criteria

Inclusion Criteria:

1. The patient must be able to understand and give written consent.
2. Women and men between 18 and 65 years old.
3. Patients with chronic kidney disease who are on renal therapy replacement with dialysis.
4. 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.
5. cPRA calculated of more than 97% and having been in the program of prioritization for more than 3 years
6. Positive IgG serologies for Cytomegalovirus and Epstein Barr.
7. 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.).
8. Patients vaccinated against tetanus, influenza, pneumococcus and herpes zoster

Exclusion Criteria:

1. Current known infection, recurrent bacteria, virus, fungus or fungus bacteria, or other infections (such as HIV, hepatitis B, hepatitis C, or zoster).
2. Concomitant serious uncontrolled major organ disease.
3. Any infection that requires hospitalization and intravenous treatment with antibiotics during the 4 weeks prior to screening, or oral treatment with antibiotics the previous 2 weeks.
4. Patients with primary or secondary immunodeficiencies.
5. Patient with an active history of tuberculosis (even if treated) or patients with untreated latent tuberculosis.
6. Malignancy during the 5 years prior to screening, except for carcinoma of the basal cell or squamous cell carcinoma properly removed.
7. Known abuse of alcohol, drugs or chemicals within 1 year prior to screening.
8. Patients with complicated peripheral venous access
9. Neutropenia (ANC \<1000/uL) or thrombocytopenia (platelet count \<100,000/uL) during the 4 weeks prior to screening.
10. Severe allergic or anaphylactic reactions to human monoclonal antibodies, humanized or murine.
11. Treatment with any investigational agent during the 4 weeks (or 5 half-lives of the investigational drug, whichever is longer) prior to screening.
12. Immunization with live vaccine during the 2 months prior to screening.
13. Pregnant or breastfeeding women.

Where this trial is running

Barcelona

• Hospital Universitari Vall d'Hebron — Barcelona, Spain (Recruiting)

Study contacts

• Study coordinator: Oriol Bestard, MD, PhD

Conditions Kidney Disease; Kidney Transplant; Kidney Transplant Candidates; HLA; TPHa; Kidney transplant; hypersensitized patient; cPRA