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

Not Applicable

Recruiting

• Conditions: Kidney Transplant Rejection

• Registration Number: NCT04414735
• Lead Sponsor: Fundacion Clinic per a la Recerca Biomédica

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-30
• Study First Submitted QC: 2020-05-30
• Study First Posted: 2020-06-04
• Study Start: 2022-08-17
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-04
• Last Update Posted: 2023-07-06
• Primary Completion: 2025-03
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Biopsy proved acute rejection	1 year after kidney transplantation
Glomerular filtrate rate at one year after kidney transplant	1 year after kidney transplantation

Trial Locations

Locations (1)

Deparment of Nephology and Kidney Transplant; 🇪🇸 Barcelona, Please Select, Spain