NCT04414735

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 4, 2020

Completed
2.2 years until next milestone

Study Start

First participant enrolled

August 17, 2022

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

July 6, 2023

Status Verified

July 1, 2023

Enrollment Period

2.5 years

First QC Date

May 30, 2020

Last Update Submit

July 4, 2023

Conditions

Kidney Transplant Rejection

Keywords

Kidney Transplant RejectionphotopheresisAntibody-mediated rejectionChronic active antibody-mediated rejection

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Biopsy proved acute rejection

    1 year after kidney transplantation

  • Glomerular filtrate rate at one year after kidney transplant

    1 year after kidney transplantation

Study Arms (2)

1- Control group (Standard immunosuppression)

NO INTERVENTION

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

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

Interventions

Extracorporeal PhotopheresisOTHER

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.

2- Treatment group (ECP+Standard immunosuppression)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Deparment of Nephology and Kidney Transplant

Barcelona, Please Select, 08036, Spain

RECRUITING

Related Publications (9)

  • Jaksch P, Knobler R. ECP and solid organ transplantation. Transfus Apher Sci. 2014 Jun;50(3):358-62. doi: 10.1016/j.transci.2014.04.006. Epub 2014 Apr 13.

    PMID: 24768429BACKGROUND

  • Heshmati F. Updating ECP action mechanisms. Transfus Apher Sci. 2014 Jun;50(3):330-9. doi: 10.1016/j.transci.2014.04.003. Epub 2014 Apr 13.

    PMID: 24837416BACKGROUND

  • Rose EA, Barr ML, Xu H, Pepino P, Murphy MP, McGovern MA, Ratner AJ, Watkins JF, Marboe CC, Berger CL. Photochemotherapy in human heart transplant recipients at high risk for fatal rejection. J Heart Lung Transplant. 1992 Jul-Aug;11(4 Pt 1):746-50.

    PMID: 1498142BACKGROUND

  • Barr ML, Meiser BM, Eisen HJ, Roberts RF, Livi U, Dall'Amico R, Dorent R, Rogers JG, Radovancevic B, Taylor DO, Jeevanandam V, Marboe CC. Photopheresis for the prevention of rejection in cardiac transplantation. Photopheresis Transplantation Study Group. N Engl J Med. 1998 Dec 10;339(24):1744-51. doi: 10.1056/NEJM199812103392404.

    PMID: 9845709BACKGROUND

  • Barr ML, Baker CJ, Schenkel FA, McLaughlin SN, Stouch BC, Starnes VA, Rose EA. Prophylactic photopheresis and chronic rejection: effects on graft intimal hyperplasia in cardiac transplantation. Clin Transplant. 2000 Apr;14(2):162-6. doi: 10.1034/j.1399-0012.2000.140211.x.

    PMID: 10770423BACKGROUND

  • Kirklin JK, Brown RN, Huang ST, Naftel DC, Hubbard SM, Rayburn BK, McGiffin DC, Bourge RB, Benza RL, Tallaj JA, Pinderski LJ, Pamboukian SV, George JF, Marques M. Rejection with hemodynamic compromise: objective evidence for efficacy of photopheresis. J Heart Lung Transplant. 2006 Mar;25(3):283-8. doi: 10.1016/j.healun.2005.10.004. Epub 2006 Jan 25.

    PMID: 16507420BACKGROUND

  • Pecoraro Y, Carillo C, Diso D, Mantovani S, Cimino G, De Giacomo T, Troiani P, Shafii M, Gherzi L, Amore D, Rendina EA, Venuta F, Anile M. Efficacy of Extracorporeal Photopheresis in Patients With Bronchiolitis Obliterans Syndrome After Lung Transplantation. Transplant Proc. 2017 May;49(4):695-698. doi: 10.1016/j.transproceed.2017.02.035.

    PMID: 28457374BACKGROUND

  • Jaksch P, Scheed A, Keplinger M, Ernst MB, Dani T, Just U, Nahavandi H, Klepetko W, Knobler R. A prospective interventional study on the use of extracorporeal photopheresis in patients with bronchiolitis obliterans syndrome after lung transplantation. J Heart Lung Transplant. 2012 Sep;31(9):950-7. doi: 10.1016/j.healun.2012.05.002.

    PMID: 22884382BACKGROUND

  • Kusztal M, Koscielska-Kasprzak K, Gdowska W, Zabinska M, Myszka M, Klak R, Krajewska M, Boratynska M, Szyber P, Chudoba P, Patrzalek D, Klinger M. Extracorporeal photopheresis as an antirejection prophylaxis in kidney transplant recipients: preliminary results. Transplant Proc. 2011 Oct;43(8):2938-40. doi: 10.1016/j.transproceed.2011.08.061.

    PMID: 21996194BACKGROUND

MeSH Terms

Interventions

Photopheresis

Intervention Hierarchy (Ancestors)

PUVA TherapyUltraviolet TherapyPhototherapyTherapeuticsExtracorporeal CirculationSurgical Procedures, Operative

Central Study Contacts

Diekmann

CONTACT

+34932275400fdiekman@clinic.cat

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Unicentric, randomized, open study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the Experimental Laboratory of Nephrology and Transplantation (LENIT)

Study Record Dates

First Submitted

May 30, 2020

First Posted

June 4, 2020

Study Start

August 17, 2022

Primary Completion

March 1, 2025

Study Completion

December 1, 2025

Last Updated

July 6, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)