- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04414735
Impact of Photopheresis in the Prevention of Acute Rejection in Highly Sensitized de Novo Kidney Transplant Recipients
July 4, 2023 updated by: Fritz Diekmann, Fundacion Clinic per a la Recerca Biomédica
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Diekmann
- Phone Number: 5444 +34932275400
- Email: fdiekman@clinic.cat
Study Locations
-
-
Please Select
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Barcelona, Please Select, Spain, 08036
- Recruiting
- Deparment of Nephology and Kidney Transplant
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Contact:
- Gastón J Piñeiro, MD
- Email: gjpineir@clinic.cat
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Sub-Investigator:
- Gastón J Piñeiro, MD
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Principal Investigator:
- Fritz Diekmann, MD,PhD
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Sub-Investigator:
- Jordi Rovira, PhD
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Sub-Investigator:
- Pedro Ventura, MD, PhD
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Contact:
- Fritz Diekmann, MD, PhD
- Phone Number: 5444 +34932275400
- Email: fdiekman@clinic.cat
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 73 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: 1- Control group (Standard immunosuppression)
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.
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|
Experimental: 2- Treatment group (ECP+Standard immunosuppression)
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
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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.
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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 Frame: 1 year after kidney transplantation
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Time to first histological rejection in the first year of kidney transplantation.
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1 year after kidney transplantation
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Biopsy proved acute rejection
Time Frame: 1 year after kidney transplantation
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1 year after kidney transplantation
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Glomerular filtrate rate at one year after kidney transplant
Time Frame: 1 year after kidney transplantation
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1 year after kidney transplantation
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 17, 2022
Primary Completion (Estimated)
March 1, 2025
Study Completion (Estimated)
December 1, 2025
Study Registration Dates
First Submitted
May 30, 2020
First Submitted That Met QC Criteria
May 30, 2020
First Posted (Actual)
June 4, 2020
Study Record Updates
Last Update Posted (Actual)
July 6, 2023
Last Update Submitted That Met QC Criteria
July 4, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- HCB/2018/0853
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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