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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04414735

Enrollment

Registered

2020-06-04

Start date

2022-08-17

Completion date

2025-12-31

Last updated

2023-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Transplant Rejection

Keywords

Kidney Transplant Rejection, photopheresis, Antibody-mediated rejection, Chronic active antibody-mediated rejection

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.

Interventions

OTHERExtracorporeal 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Intervention model description

Unicentric, randomized, open study.

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Time to first histological rejection in the first year of kidney transplantation.	1 year after kidney transplantation	Time to first histological rejection in the first year of kidney transplantation.

Secondary

Measure	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

Countries

Spain

Contacts

Primary ContactDiekmann

fdiekman@clinic.cat+34932275400

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026