Clinical trial NCT04414735: Impact of Photopheresis in the Prevention of Acute Rejection in Highly Sensitized de Novo Kidney Transplant Recipients
Official title: Impact of Photopheresis in the Prevention of Acute Rejection in Highly Sensitized de Novo Kidney Transplant Recipients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Kidney Transplant Rejection
Keywords: Kidney Transplant Rejection
photopheresis
Antibody-mediated rejection
Chronic active antibody-mediated rejection
Lead sponsor: Fundacion Clinic per a la Recerca Biomédica
Sponsor class: OTHER
Collaborators: name: Mallinckrodt
First posted: 2020-06-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Unicentric, randomized, open study.
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Time to first histological rejection in the first year of kidney transplantation.
timeFrame: 1 year after kidney transplantation
Secondary outcomes:
measure: Biopsy proved acute rejection
timeFrame: 1 year after kidney transplantation
measure: Glomerular filtrate rate at one year after kidney transplant
timeFrame: 1 year after kidney transplantation
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Deparment of Nephology and Kidney Transplant
state: Please Select
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.