Chronic Kidney Disease Clinical Trials

Find Chronic Kidney Disease Clinical Trials Near You

Immune Reset to Allow Access to Hla-compatible Kidney Transplantation in Hyperimmunized Patients

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Spain
Hospital Universitari Vall d'Hebron
RECRUITING
Barcelona
Contact Information
Primary
Oriol Bestard, Nephrologist
oriol.bestard@vallhebron.cat
34932607400
Time Frame
Start Date: 2024-02-01
Estimated Completion Date: 2028-06
Participants
Target number of participants: 10
Treatments
Experimental: Autologous Hematopoietic Stem Cell Transplantation (AHSCT)
Participants undergo a non-myeloablative conditioning regimen for intense lymphodepletion consisting of intravenous Rituximab, Cyclophosphamide (adjusted for end-stage renal disease), and Thymoglobulin (rATG). This is followed by peripheral blood stem cell collection via leukapheresis, CD34+ immunomagnetic selection, and the reinfusion of purified autologous CD34+ progenitors (target dose \>= 3 x 10⁶ cells/kg). At 6 months post-AHSCT, patients are reactivated on the deceased-donor kidney transplant waiting list.
Sponsors
Collaborators: Hospital Clinic of Barcelona
Leads: Hospital Universitari Vall d'Hebron Research Institute

This content was sourced from clinicaltrials.gov

Similar Clinical Trials