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Peri-operative rATG-perfusion of Solid Transplants (ATG-perfusion)

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ClinicalTrials.gov Identifier: NCT03377283
Recruitment Status : Completed
First Posted : December 19, 2017
Last Update Posted : December 22, 2017
Sponsor:
Information provided by (Responsible Party):
Katja Kotsch, Medical University Innsbruck

Brief Summary:

The increasing demand for organ transplantation and the shortage of available organs limit the success of organ transplantation programs. Consequently, acceptance of expanded criteria donor (ECD) organs with the consequences of higher risk of unfavorable transplantation outcome has become an increasing reality. Among the most prominent characteristics distinguishing ECD from Standard Criteria Donors (SCD) are risk factors including brain death (BD) or prolonged cold ischemia time (CI) amplifying ischemia reperfusion injury (IRI). Currently there are no standard regimens to improve the quality of ECD organs. Therefore, donor organ treatment might be a promising approach to substantially improve organ quality. It will be investigated whether the application of the peri-operative perfusion of kidneys and livers with the polyclonal antibody rabbit antithymocyte globulin (rATG) ameliorates IRI.

This trial is designed as a parallel armed randomized controlled trial.


Condition or disease Intervention/treatment Phase
Organ Preservation Solutions Biological: organ perfusion with rabbit anti-thymocyte globulin (rATG) Other: organ perfusion with saline Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Reduction of Ischemic-reperfusion Injury by Ex-vivo ATG-perfusion of Kidneys and Livers Prior Organ Transplantation
Actual Study Start Date : August 17, 2012
Actual Primary Completion Date : March 4, 2015
Actual Study Completion Date : February 24, 2016

Arm Intervention/treatment
Active Comparator: AP-KTx/LTx
Transplant recipients receiving an rATG-perfused kidney or liver
Biological: organ perfusion with rabbit anti-thymocyte globulin (rATG)
Placebo Comparator: CP-KTx/LTx
Transplant recipients receiving a control-perfused kidney or liver.
Other: organ perfusion with saline



Primary Outcome Measures :
  1. Graft function [ Time Frame: Day 7 ]
    Graft function from baseline defined as serum creatinine (KTx arm) and aspartate transaminase (LTx arm).


Secondary Outcome Measures :
  1. Graft function - creatinine [ Time Frame: Days 1-7 post transplantation, month 3, month 6, month 12 ]
    Graft function from baseline defined as serum creatinine (mg/dL) for the KTx arm.

  2. Graft function - glomeralur filtration rate [ Time Frame: Days 1-7 post transplantation, month 3, month 6, month 12 ]
    Graft function from baseline defined as glomerular filtration rate (ml/min/1.73M2) for the KTx arm.

  3. Graft function - serum urea [ Time Frame: Days 1-7 post transplantation, month 3, month 6, month 12 ]
    Graft function from baseline defined as serum urea (mg/dL) for the KTx arm.

  4. Graft function - aspartate transaminase [ Time Frame: Days 1-7 post transplantation, month 3, month 6, month 12 ]
    Graft function from baseline defined as aspartate transaminase (mg/dL) for LTx arm.

  5. Graft function - alanine transaminase [ Time Frame: Days 1-7 post transplantation, month 3, month 6, month 12 ]
    Graft function from baseline defined as alanine transaminase (mg/dL) for LTx arm.

  6. Graft function - total serum bilirubin [ Time Frame: Days 1-7 post transplantation, month 3, month 6, month 12 ]
    Graft function from baseline defined as total serum bilirubin (mg/dL) for LTx arm.

  7. Graft function - gamma-glutamyl transpeptidase [ Time Frame: Days 1-7 post transplantation, month 3, month 6, month 12 ]
    Graft function from baseline defined as gamma-glutamyl transpeptidase (mg/dL) for LTx arm.

  8. Graft function - alkaline phosphatase [ Time Frame: Days 1-7 post transplantation, month 3, month 6, month 12 ]
    Graft function from baseline defined as alkaline phosphatase (mg/dL) for LTx arm.

  9. Graft function - quick value [ Time Frame: Days 1-7 post transplantation, month 3, month 6, month 12 ]
    Graft function from baseline defined as quick value (%) for LTx arm.

  10. Patient age - recipient [ Time Frame: Day zero, at the time point of transplantation ]
    Recipient age (years).

  11. Patient age - donor [ Time Frame: Day zero, at the time point of transplantation ]
    Donor age (years).

  12. BMI - recipient [ Time Frame: Day zero, at the time point of transplantation ]
    Recipient BMI (weight (lb) / [height (in)]2 x 703).

  13. BMI - donor [ Time Frame: Day zero, at the time point of transplantation ]
    Donor BMI (weight (lb) / [height (in)]2 x 703).

  14. Sex - recipient [ Time Frame: Day zero, at the time point of transplantation ]
    Recipient sex.

  15. Sex - donor [ Time Frame: Day zero, at the time point of transplantation ]
    Donor sex.

  16. Cold ischemia time [ Time Frame: during transplantation ]
    Cold ischemia time (hours) from cross-clamping until start of anastomosis.

  17. Warm ischemia time [ Time Frame: during transplantation ]
    Warm ischemia time (hours) is the time from start of anastomosis until reperfusion.

  18. Panel-reactive antibodies [ Time Frame: Day zero, at the time point of transplantation ]
    Presence of panel-reactive antibodies (%) in KTx recipients.

  19. Hospital stay [ Time Frame: after transplantation ]
    Hospital stay (days) after transplantation

  20. ICU stay [ Time Frame: after transplantation ]
    Intensive care unit stay (days) after transplantation

  21. Mortality [ Time Frame: up to 12 month ]
    Death rate in the investigated groups.

  22. Graft loss [ Time Frame: up to 12 month ]
    Graft loss rate in the investigated groups.

  23. HLA missmatch [ Time Frame: Day zero, at the time point of transplantation ]
    Human leukocyte antigen mismatches in KTx recipients.

  24. Delayed graft function [ Time Frame: after transplantation ]
    Development of delayed graft function (requirement of dialysis within the first 7 post operative days) in KTx recipients.

  25. Experimental analysis of perioperative taken biopsies [ Time Frame: Peri-operatively (zero hour biopsy) ]
    mRNA Expression of pro-inflammatory and anti-inflammatory cytokine/chemokine pattern in biopsies will be analysed to evaluate immunactivation of the organ

  26. Experimental analysis of peripheral blood monunuclear cells [ Time Frame: prior transplantation, days 1-7 post transplantation, month 3, month 6, month 12 for lymphocyte expression analysis of peripheral blood ]
    Leukocyte-composition and activation pattern will be analysed from peripheral blood via flow cytometry of the recipient and the donor



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients receiving a kidney or liver transplant from deceased donors

Exclusion Criteria:

  • Hepatitis C Virus/Human Immunodeficiency Virus, undergoing re-transplantation or under a public guardian

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Katja Kotsch, Univ. Prof. Dr. Katja Kotsch, Medical University Innsbruck
ClinicalTrials.gov Identifier: NCT03377283     History of Changes
Other Study ID Numbers: UN4640
First Posted: December 19, 2017    Key Record Dates
Last Update Posted: December 22, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Antilymphocyte Serum
Thymoglobulin
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents