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Reperfusion InjuryNCT03378817

Hypothermic Oxygenated Machine Perfusion of Extended Criteria Kidney Allografts From Brain Death Donors

A study testing HOPE and Conventional cold storage in people with Reperfusion Injury and Hypothermic Oxygenated Machine Perfusion, run by University Hospital, Aachen at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Kidney transplantation (KT) has emerged as the mainstay of treatment for end-stage kidney disease. In an effort to address the widening gap between demand and supply of donor organs, there has been an increase in the numbers of "marginal" or functionally impaired renal allografts that had to be accepted for KT over… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
HOPE and Conventional cold storage
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteGermany
Study dates
5 Dec 2017to 30 Mar 2020
Phase
Interventional
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Dialysis-requiring Patients, suffering from end stage kidney disease, listed for KT and receiving ECD organs at the Department of Surgery and Transplantation, University Hospital RWTH Aachen, Aachen, Germany. Informed consent is obtained from all subjects participating in the trial by a qualified member of the study team.
  • ECD is defined as followed: deceased donors > 60 years and older, and those aged between 50-59 years with at least two of the following conditions: cerebrovascular cause of death, serum Creatinine greater than 1.5 mg/dL (132.6 µmol/L), history of arterial hypertension

Who cannot join

  • Recipients of living donor kidney transplants
  • Previous kidney transplantation
  • Participation in other kidney related trials
  • The subject received an investigational drug within 30 days prior to inclusion
  • The subject is unwilling or unable to follow the procedures outlined in the protocol
  • The subject is mentally or legally incapacitated
Show all 10Show fewer
  • Non-German or non-English speakers
  • Family members of the investigators or employees of the participating department
  • The subject is mentally or legally incapacitated
  • The subject suffers from uncontrolled bacterial or viral infection

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Department of Surgery and Transplantation, University Hospital RWTH Aachen

    Aachen, 52074

Other trials in Germany

About this study

Official title: Hypothermic Oxygenated Machine Perfusion of Extended Criteria Kidney Allografts From Brain Death Donors - a Prospective Cohort Study

Kidney transplantation (KT) has emerged as the mainstay of treatment for end-stage kidney disease. In an effort to address the widening gap between demand and supply of donor organs, there has been an increase in the numbers of "marginal" or functionally impaired renal allografts that had to be accepted for KT over the decades. The use of extended criteria donor (ECD) allografts is associated with a higher incidence of primary graft non-function (PNF) and/or delayed graft function (DGF). Hypothermic oxygenated machine perfusion (HOPE) has been successfully tested in pre-clinical experiments and in a few clinical series of donation after cardiac death (DCD) in liver transplantation. The present trial is an investigator-initiated pilot study on the effects of HOPE on ECD-allografts in donation after brain death (DBD) KT. Fifteen kidney allografts will be submitted to 2 hours of HOPE before implantation and are going to be compared to a case matched group transplanted after conventional cold storage (CCS).

Read the detailed description

The present trial is an investigator-initiated pilot study on the effects of HOPE on ECD-allografts in DBD KT. Fifteen kidney allografts with defined inclusion/exclusion criteria will be submitted to 2 hours of HOPE via the renal artery before implantation and are going to be compared to a case matched group of 30 patients (1:2 matching) transplanted after CCS. Besides the clinical evaluation of HOPE-"reconditioned" allograft function, a targeted biomarker analysis is planned using tissue, serum, and urine samples as the translational and basic research aspect of the present study.

Being tested
HOPE, Conventional cold storage
Keywords
Extended criteria donor, Donation after brain death, HOPE, Kidney transplantation
Medical subject headings
Reperfusion Injury

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HOPEProcedure or surgery

    HOPE for 1 hour via the renal artery in a recirculating and pressure controlled system, Belzer (UW) machine perfusion solution, perfusate temperature 0-4 °C, perfusate oxygenation pO2 of 60-80 kPa Other Name: Hypothermic machine perfusion (HMP)

  • Conventional cold storageOther

    No intervention

Study groups in NCT03378817
Study groupRoleWhat they receive
Conventional cold storageActive comparatorConventional static cold storage (CCS) on temperature 0-4 °C from organ procurement (historical case matched group)
Receives: Other: Conventional cold storage
Hypothermic oxygenated perfusion (HOPE)ExperimentalHOPE for 1 hour via the renal artery in a recirculating and pressure controlled system, Belzer (UW) machine perfusion solution, perfusate temperature 0-4 °C, perfusate oxygenation pO2 of 60-80 kPa Other Name: Hypothermic machine perfusion (HMP)
Receives: Procedure: HOPE

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. DGF

    DGF (defined as the need for dialysis in the first 7-days post-transplantation)

    Measured: 7 days post-transplant

Secondary outcomes (8)

  1. CRR2, CRR5

    Creatinine reduction ratio day 2 (CRR2= creatinine day 1-creatinine day 2/creatinine day 1) and CRR5 (CRR5=pre-transplant creatinine-creatinine day 5/pre-transplant creatinine)

    Measured: 5 days post-transplant

  2. postoperative complications

    Clavien-Dindo complication score

    Measured: Subjects will be followed 6 months postoperatively

  3. Cumulative postoperative complications

    Comprehensive complication index (CCI)

    Measured: Subjects will be followed 6 months postoperatively

  4. Duration of intensive care stay

    Duration of ICU stay

    Measured: Subjects will be followed 6 months postoperatively

  5. Duration of hospital stay

    Duration of hospitalisation

    Measured: Subjects will be followed 6 months postoperatively

  6. Graft survival

    Six months graft survival

    Measured: Subjects will be followed 6 months postoperatively

  7. Renal function

    Renal function (serum creatinine and estimated glomerular filtration rate (eGFR))

    Measured: Subjects will be followed 6 months postoperatively

  8. Perfusion Parameter

    Flow and thus renal resistance

    Measured: During HOPE

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Dec 2017
  2. Study start5 Dec 2017
  3. Primary completion30 Sep 2019
  4. Study completion30 Mar 2020

Resources

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 N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Pilot study, case matched (1:2)
Masking
None (open label)
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03378817
Sponsor's protocol ID
EK 184-17
Status last verified
Apr 2020
First submitted
8 Dec 2017
Last updated
7 Apr 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Meister FA, Czigany Z, Rietzler K, Miller H, Reichelt S, Liu WJ, Boecker J, Moeller MJ, Tolba RH, Hamesch K, Strnad P, Boor P, Stoppe C, Neumann UP, Lurje G. Decrease of renal resistance during hypothermic oxygenated machine perfusion is associated with early allograft function in extended criteria donation kidney transplantation. Sci Rep. 2020 Oct 20;10(1):17726. doi: 10.1038/s41598-020-74839-7.

    PubMed 33082420

  • Meister FA, Czigany Z, Bednarsch J, Bocker J, Amygdalos I, Morales Santana DA, Rietzler K, Moeller M, Tolba R, Boor P, Rohlfs W, Neumann UP, Lurje G. Hypothermic Oxygenated Machine Perfusion of Extended Criteria Kidney Allografts from Brain Dead Donors: Protocol for a Prospective Pilot Study. JMIR Res Protoc. 2019 Oct 14;8(10):e14622. doi: 10.2196/14622.

    PubMed 31613224

Questions about this trial

What is this clinical trial studying?

A study testing HOPE and Conventional cold storage in people with Reperfusion Injury and Hypothermic Oxygenated Machine Perfusion, run by University Hospital, Aachen at 1 site in Germany.

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 2 inclusion and 10 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 7 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

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?

DGF (time frame: 7 days post-transplant). 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 NCT03378817, which also lists 2 linked publications.

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 7 Apr 2020.

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