Impact of Photopheresis in the Prevention of Acute Rejection in Highly Sensitized de Novo Kidney Transplant Recipients

Launched by FUNDACION CLINIC PER A LA RECERCA BIOMÉDICA · May 30, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called photopheresis to see if it can help prevent kidney transplant rejection in patients who are highly sensitized. "Highly sensitized" means these patients have a very high level of antibodies in their blood, making it harder for their bodies to accept a new kidney. The trial compares the effects of photopheresis combined with standard medications to prevent rejection against just using the standard medications alone.

To be eligible for this trial, participants need to be between 18 and 75 years old and be sensitized, meaning they have a calculated panel reactive antibody (cPRA) score of 90% or higher. This score indicates a high likelihood of rejection. Participants should also be able to understand and sign consent forms. Those currently involved in other clinical trials or using certain medications like Rituximab or Eculizumab cannot participate. If someone joins the trial, they can expect to receive either the photopheresis treatment or standard care, and their progress will be closely monitored. This study is important because it could help improve outcomes for kidney transplant recipients who face a greater risk of rejection.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Sensitized (cPRA ≥90%) candidates for a deceased-donor kidney transplantation
• • Recipients between 18 and 75 years old
• • Patients are able to understand and sign informed consent (Annex 1).
• Exclusion Criteria:
• • Participation in another interventional clinical trial.
• • Use of Rituximab or Eculizumab at the time of transplant or in the first 24 hours post-transplant.
• • Persons with any dependency on the researcher or employee by the responsible institution or researcher. As well as people detained by legal order.