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

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Kidney Transplant Rejection

Intervention / Treatment
-----------------
* Other: Extracorporeal Photopheresis


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Unicentric, randomized, open study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1- Control group (Standard immunosuppression)<br>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. | |
| Experimental: 2- Treatment group (ECP+Standard immunosuppression)<br>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 | Other: Extracorporeal Photopheresis<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first histological rejection in the first year of kidney transplantation. | Time to first histological rejection in the first year of kidney transplantation. | 1 year after kidney transplantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biopsy proved acute rejection |  | 1 year after kidney transplantation | 
| Glomerular filtrate rate at one year after kidney transplant |  | 1 year after kidney transplantation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Kidney Transplant Rejection, photopheresis, Antibody-mediated rejection, Chronic active antibody-mediated rejection