MedTrace Logo

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

NCT04414735 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-07-06

No results posted yet for this study

Summary

The aim of the present study is to evaluate the superiority of photopheresis in combination with the standard immunosuppression vs standard immunosuppression alone for the prevention of acute rejection in highly sensitized kidney transplant recipients (cPRA ≥90%).

Unicentric, randomized, open study.

Conditions

  • Kidney Transplant Rejection

Interventions

OTHER

Extracorporeal Photopheresis

Infusion of autologous cellular products exposed to ultraviolet light (UV), in the presence of a photosensitizer. The cellular product is obtained through leucopheresis and its subsequent exposure to 8-methoxypsoralen (8-MOP) and irradiation with UV-A light.

Sponsors & Collaborators

  • Mallinckrodt

    collaborator INDUSTRY

  • Fundacion Clinic per a la Recerca Biomédica

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-17
Primary Completion
2025-03-31
Completion
2025-12-31

Countries

  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04414735 on ClinicalTrials.gov