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

Fundacion Clinic per a la Recerca Biomédica

Status: Enrolling

Conditions: Kidney Transplant Rejection

Treatments: Other: Extracorporeal Photopheresis

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04414735

HCB/2018/0853

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

1- Control group (Standard immunosuppression)

No Intervention group

Description:

1- Control group (n=15): Standard immunosuppression (Thymoglobulin, Prednisone, Tacrolimus, and Everolimus or Mycophenolate), according to the clinical protocol of the Nephrology and Kidney Transplant Department.

2- Treatment group (ECP+Standard immunosuppression)

Experimental group

Description:

2- Treatment group (n=15): Extracorporeal photopheresis in combination with standard immunosuppression (Thymoglobulin, Prednisone, Tacrolimus, and Everolimus or Mycophenolate) according to the clinical protocol of the Nephrology and Kidney Transplant Department

Treatment:

Other: Extracorporeal Photopheresis