Organ Preservation SolutionsPhase 4ATG-perfusionNCT03377283
Peri-operative rATG-perfusion of Solid Transplants
A Phase 4 study testing organ perfusion with rabbit anti-thymocyte globulin (rATG) and organ perfusion with saline in people with Organ Preservation Solutions, run by Medical University Innsbruck.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Organ Preservation Solutions
- What is being tested?
- organ perfusion with rabbit anti-thymocyte globulin (rATG) and organ perfusion with saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 17 Aug 2012to 24 Feb 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients receiving a kidney or liver transplant from deceased donors
Who cannot join
- Hepatitis C Virus/Human Immunodeficiency Virus, undergoing re-transplantation or under a public guardian
About this study
Official title: 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.
- Conditions
- Organ Preservation Solutions
- Being tested
- organ perfusion with rabbit anti-thymocyte globulin (rATG), organ perfusion with saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
organ perfusion with rabbit anti-thymocyte globulin (rATG)Biological
organ perfusion with salineOther
| Study group | Role | What they receive |
|---|---|---|
| AP-KTx/LTx | Active comparator | Transplant recipients receiving an rATG-perfused kidney or liver Receives: Biological: organ perfusion with rabbit anti-thymocyte globulin (rATG) |
| CP-KTx/LTx | Placebo comparator | Transplant recipients receiving a control-perfused kidney or liver. Receives: Other: organ perfusion with saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Graft function
Graft function from baseline defined as serum creatinine (KTx arm) and aspartate transaminase (LTx arm).
Measured: Day 7
Secondary outcomes (26)
Graft function - creatinine
Graft function from baseline defined as serum creatinine (mg/dL) for the KTx arm.
Measured: Days 1-7 post transplantation, month 3, month 6, month 12
Graft function - glomeralur filtration rate
Graft function from baseline defined as glomerular filtration rate (ml/min/1.73M2) for the KTx arm.
Measured: Days 1-7 post transplantation, month 3, month 6, month 12
Graft function - serum urea
Graft function from baseline defined as serum urea (mg/dL) for the KTx arm.
Measured: Days 1-7 post transplantation, month 3, month 6, month 12
Graft function - aspartate transaminase
Graft function from baseline defined as aspartate transaminase (mg/dL) for LTx arm.
Measured: Days 1-7 post transplantation, month 3, month 6, month 12
Graft function - alanine transaminase
Graft function from baseline defined as alanine transaminase (mg/dL) for LTx arm.
Measured: Days 1-7 post transplantation, month 3, month 6, month 12
Graft function - total serum bilirubin
Graft function from baseline defined as total serum bilirubin (mg/dL) for LTx arm.
Measured: Days 1-7 post transplantation, month 3, month 6, month 12
Graft function - gamma-glutamyl transpeptidase
Graft function from baseline defined as gamma-glutamyl transpeptidase (mg/dL) for LTx arm.
Measured: Days 1-7 post transplantation, month 3, month 6, month 12
Graft function - alkaline phosphatase
Graft function from baseline defined as alkaline phosphatase (mg/dL) for LTx arm.
Measured: Days 1-7 post transplantation, month 3, month 6, month 12
Graft function - quick value
Graft function from baseline defined as quick value (%) for LTx arm.
Measured: Days 1-7 post transplantation, month 3, month 6, month 12
Patient age - recipient
Recipient age (years).
Measured: Day zero, at the time point of transplantation
Patient age - donor
Donor age (years).
Measured: Day zero, at the time point of transplantation
BMI - recipient
Recipient BMI (weight (lb) / [height (in)]2 x 703).
Measured: Day zero, at the time point of transplantation
BMI - donor
Donor BMI (weight (lb) / [height (in)]2 x 703).
Measured: Day zero, at the time point of transplantation
Sex - recipient
Recipient sex.
Measured: Day zero, at the time point of transplantation
Sex - donor
Donor sex.
Measured: Day zero, at the time point of transplantation
Cold ischemia time
Cold ischemia time (hours) from cross-clamping until start of anastomosis.
Measured: during transplantation
Warm ischemia time
Warm ischemia time (hours) is the time from start of anastomosis until reperfusion.
Measured: during transplantation
Panel-reactive antibodies
Presence of panel-reactive antibodies (%) in KTx recipients.
Measured: Day zero, at the time point of transplantation
Hospital stay
Hospital stay (days) after transplantation
Measured: after transplantation
ICU stay
Intensive care unit stay (days) after transplantation
Measured: after transplantation
Mortality
Death rate in the investigated groups.
Measured: up to 12 month
Graft loss
Graft loss rate in the investigated groups.
Measured: up to 12 month
HLA missmatch
Human leukocyte antigen mismatches in KTx recipients.
Measured: Day zero, at the time point of transplantation
Delayed graft function
Development of delayed graft function (requirement of dialysis within the first 7 post operative days) in KTx recipients.
Measured: after transplantation
Experimental analysis of perioperative taken biopsies
mRNA Expression of pro-inflammatory and anti-inflammatory cytokine/chemokine pattern in biopsies will be analysed to evaluate immunactivation of the organ
Measured: Peri-operatively (zero hour biopsy)
Experimental analysis of peripheral blood monunuclear cells
Leukocyte-composition and activation pattern will be analysed from peripheral blood via flow cytometry of the recipient and the donor
Measured: prior transplantation, days 1-7 post transplantation, month 3, month 6, month 12 for lymphocyte expression analysis of peripheral blood
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2017
- Study start17 Aug 2012
- Primary completion4 Mar 2015
- Study completion24 Feb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Organ Preservation SolutionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katja Kotsch, Medical University Innsbruck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03377283
- Sponsor's protocol ID
- UN4640
- Acronym
- ATG-perfusion
- Status last verified
- Dec 2017
- First submitted
- 28 Nov 2017
- Last updated
- 22 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ritschl PV, Gunther J, Hofhansel L, Kuhl AA, Sattler A, Ernst S, Friedersdorff F, Ebner S, Weiss S, Bosmuller C, Weissenbacher A, Oberhuber R, Cardini B, Ollinger R, Schneeberger S, Biebl M, Denecke C, Margreiter C, Resch T, Aigner F, Maglione M, Pratschke J, Kotsch K. Graft Pre-conditioning by Peri-Operative Perfusion of Kidney Allografts With Rabbit Anti-human T-lymphocyte Globulin Results in Improved Kidney Graft Function in the Early Post-transplantation Period-a Prospective, Randomized Placebo-Controlled Trial. Front Immunol. 2018 Aug 24;9:1911. doi: 10.3389/fimmu.2018.01911. eCollection 2018.
PubMed 30197644
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Ischemic-reperfusion Injury by Ex-vivo ATG-perfusion of Kidneys and Livers Prior Organ Transplantation
- ClinicalTrials.gov ID
- NCT03377283
- Acronym / sponsor ID
- ATG-perfusion / UN4640
- Conditions
- Organ Preservation Solutions
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Study start
- 17 Aug 2012 (actual)
- Primary completion
- 4 Mar 2015 (actual)
- Study completion
- 24 Feb 2016 (actual)
- First posted
- 19 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AP-KTx/LTx | Active comparator | Biological: organ perfusion with rabbit anti-thymocyte globulin (rATG)Transplant recipients receiving an rATG-perfused kidney or liver |
| CP-KTx/LTx | Placebo comparator | Other: organ perfusion with salineTransplant recipients receiving a control-perfused kidney or liver. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients receiving a kidney or liver transplant from deceased donors
Key exclusion criteria (1 listed)
- Hepatitis C Virus/Human Immunodeficiency Virus, undergoing re-transplantation or under a public guardian
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| organ perfusion with rabbit anti-thymocyte globulin (rATG) | Biological | AP-KTx/LTx |
| organ perfusion with saline | Other | CP-KTx/LTx |
Primary outcome
Graft function
Time frame: Day 7
Graft function from baseline defined as serum creatinine (KTx arm) and aspartate transaminase (LTx arm).
26 secondary outcomes
Graft function - creatinine
Time frame: 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 - serum urea
Time frame: 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 - alanine transaminase
Time frame: 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 - gamma-glutamyl transpeptidase
Time frame: 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 - quick value
Time frame: Days 1-7 post transplantation, month 3, month 6, month 12
Patient age - recipient
Time frame: Day zero, at the time point of transplantation
Patient age - donor
Time frame: Day zero, at the time point of transplantation
BMI - recipient
Time frame: Day zero, at the time point of transplantation
BMI - donor
Time frame: Day zero, at the time point of transplantation
Sex - recipient
Time frame: Day zero, at the time point of transplantation
Sex - donor
Time frame: Day zero, at the time point of transplantation
Cold ischemia time
Time frame: during transplantation
Warm ischemia time
Time frame: during transplantation
Panel-reactive antibodies
Time frame: Day zero, at the time point of transplantation
Hospital stay
Time frame: after transplantation
ICU stay
Time frame: after transplantation
Mortality
Time frame: up to 12 month
Graft loss
Time frame: up to 12 month
HLA missmatch
Time frame: Day zero, at the time point of transplantation
Delayed graft function
Time frame: after transplantation
Experimental analysis of perioperative taken biopsies
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2017.
- Derived from this study: PubMed 30197644Ritschl PV, Gunther J, Hofhansel L, Kuhl AA, Sattler A, Ernst S, Friedersdorff F, Ebner S, Weiss S, Bosmuller C, Weissenbacher A, Oberhuber R, Cardini B, Ollinger R, Schneeberger S, Biebl M, Denecke C, Margreiter C, Resch T, Aigner F, Maglione M, Pratschke J, Kotsch K. Graft Pre-conditioning by Peri-Operative Perfusion of Kidney Allografts With Rabbit Anti-human T-lymphocyte Globulin Results in Improved Kidney Graft Function in the Early Post-transplantation Period-a Prospective, Randomized Placebo-Controlled Trial. Front Immunol. 2018 Aug 24;9:1911. doi: 10.3389/fimmu.2018.01911. eCollection 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing organ perfusion with rabbit anti-thymocyte globulin (rATG) and organ perfusion with saline in people with Organ Preservation Solutions, run by Medical University Innsbruck.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Graft function (time frame: Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03377283, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2017.