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

December 20, 2017 updated by: Katja Kotsch, Medical University Innsbruck

Reduction of Ischemic-reperfusion Injury by Ex-vivo ATG-perfusion of Kidneys and Livers Prior Organ Transplantation

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Graft function
Time Frame: Day 7
Graft function from baseline defined as serum creatinine (KTx arm) and aspartate transaminase (LTx arm).
Day 7

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Days 1-7 post transplantation, month 3, month 6, month 12
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.
Days 1-7 post transplantation, month 3, month 6, month 12
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.
Days 1-7 post transplantation, month 3, month 6, month 12
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.
Days 1-7 post transplantation, month 3, month 6, month 12
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.
Days 1-7 post transplantation, month 3, month 6, month 12
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.
Days 1-7 post transplantation, month 3, month 6, month 12
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.
Days 1-7 post transplantation, month 3, month 6, month 12
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.
Days 1-7 post transplantation, month 3, month 6, month 12
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.
Days 1-7 post transplantation, month 3, month 6, month 12
Patient age - recipient
Time Frame: Day zero, at the time point of transplantation
Recipient age (years).
Day zero, at the time point of transplantation
Patient age - donor
Time Frame: Day zero, at the time point of transplantation
Donor age (years).
Day zero, at the time point of transplantation
BMI - recipient
Time Frame: Day zero, at the time point of transplantation
Recipient BMI (weight (lb) / [height (in)]2 x 703).
Day zero, at the time point of transplantation
BMI - donor
Time Frame: Day zero, at the time point of transplantation
Donor BMI (weight (lb) / [height (in)]2 x 703).
Day zero, at the time point of transplantation
Sex - recipient
Time Frame: Day zero, at the time point of transplantation
Recipient sex.
Day zero, at the time point of transplantation
Sex - donor
Time Frame: Day zero, at the time point of transplantation
Donor sex.
Day zero, at the time point of transplantation
Cold ischemia time
Time Frame: during transplantation
Cold ischemia time (hours) from cross-clamping until start of anastomosis.
during transplantation
Warm ischemia time
Time Frame: during transplantation
Warm ischemia time (hours) is the time from start of anastomosis until reperfusion.
during transplantation
Panel-reactive antibodies
Time Frame: Day zero, at the time point of transplantation
Presence of panel-reactive antibodies (%) in KTx recipients.
Day zero, at the time point of transplantation
Hospital stay
Time Frame: after transplantation
Hospital stay (days) after transplantation
after transplantation
ICU stay
Time Frame: after transplantation
Intensive care unit stay (days) after transplantation
after transplantation
Mortality
Time Frame: up to 12 month
Death rate in the investigated groups.
up to 12 month
Graft loss
Time Frame: up to 12 month
Graft loss rate in the investigated groups.
up to 12 month
HLA missmatch
Time Frame: Day zero, at the time point of transplantation
Human leukocyte antigen mismatches in KTx recipients.
Day zero, at the time point of transplantation
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.
after transplantation
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
Peri-operatively (zero hour biopsy)
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
prior transplantation, days 1-7 post transplantation, month 3, month 6, month 12 for lymphocyte expression analysis of peripheral blood

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical University Innsbruck

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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 17, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 4, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 24, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 28, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 13, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 19, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 22, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 20, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UN4640

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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