Immunological Reset to Enable Access to Hla-compatible Kidney Transplantation in Highly Sensitized Patients (RESET)
Recruiting
Phase 1
Phase 2
Interventional Study
Kidney Failure, Chronic
Kidney Transplantation
Alloimmunization
HLA Sensitization
End Stage Cronic Kidney Disease
Highly Sensitized Patients Awaiting Kidney Transplant
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 60
- Sex
- Any
- Trial phase
- Phase 1/2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 10 (estimated)
- Sponsor
- Hospital Universitari Vall d'Hebron Research Institute · Other
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About This Trial
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, p…
Trial Locations
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Eligibility Criteria
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 …
Contacts