Delayed Graft FunctionPhase 3HMPO2NCT05430620
Intermittent Versus Continuous Surface O2 During HMP of DCD Kidneys
A Phase 3 study testing Oxygen in people with Delayed Graft Function and Kidney Transplant; Complications, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
The aim of the study is to evaluate the feasibility of this bubble and surface oxygenation and to determine the optimal timing of surface oxygenation (continuous versus intermittent) as alternative for membrane-oxygenated kidneys, originating from DCD donors, during HMP on early graft function in clinical practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delayed Graft Function, Kidney Transplant; Complications, Ischemia Reperfusion Injury
- What is being tested?
- Oxygen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- 20 Mar 2022to 1 Jan 2026
- Phase
- Phase 3
- 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
- Listed for a renal transplantation due to end stage renal disease
- Willingness to comply with the protocol procedures for the duration of the study included scheduled follow-up visits and examinations.
Who cannot join
- Multi-organ recipients
- Dual kidney transplantation
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Cliniques Universitaires Saint-Luc
Brussels, Woluwé-Saint-Lambert, 1200
Tom Darius, MD, PhD, +3227646065, tom.darius@saintluc.uclouvain.be
Nathalie Staumont, +3227642218, nathalie.staumont@saintluc.uclouvain.be
About this study
Official title: A Prospective Feasibility Trail to Compare the Efficacy of Intermittent Surface Oxygenation With Continuous Surface Oxygenation During Hypothermic Machine Perfusion of Kidneys Donated After Circulatory Death
The aim of the study is to evaluate the feasibility of this bubble and surface oxygenation and to determine the optimal timing of surface oxygenation (continuous versus intermittent) as alternative for membrane-oxygenated kidneys, originating from DCD donors, during HMP on early graft function in clinical practice.
Read the detailed description
Kidneys originating from deceased donors after circulatory death (DCD), category 3 and 5 (controlled) will be preserved from procurement until transplantation on hypothermic machine perfusion conditions and prospectively randomized into 2 study groups: 1) intermittent surface oxygenation during HMP (surface oxygenation interrupted during organ transport (2-4h)(I-HMPO2 group), and 2) continuous surface oxygenation during HMP (surface oxygenation during the whole machine preservation period included organ transport)(C-HMPO2 group).
- Conditions
- Delayed Graft Function, Kidney Transplant; Complications, Ischemia Reperfusion Injury, Mitochondrial
- Being tested
- Oxygen
- Keywords
- Hypothermic oxygenated machine perfusion, Kidney preservation, bubble and surface oxygenation
- Medical subject headings
- Delayed Graft Function, Reperfusion Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxygenDrug
Also called feasibility of bubble and surface oxygenation applied to the LifePort Kidney Transporter (Organ Recovery Systems, Diegem, Belgium)
Active oxygenation during hypothermic machine perfusion by bubble and surface oxygenation. Intermittent surface oxygenation is compared with continuous surface oxygenation during hypothermic machine perfusion
| Study group | Role | What they receive |
|---|---|---|
| I-HMPO2 | Experimental | intermittent surface oxygenation during hypothermic machine perfusion (surface oxygenation interrupted during organ transport) Receives: Drug: Oxygen |
| C-HMPO2 | Active comparator | continuous surface oxygenation during HMP (surface oxygenation during the whole machine preservation period included organ transport) Receives: Drug: Oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional delayed graft function
defined as the absence of a decrease in the serum creatinine level of at least 10% per day for at least 3 consecutive days in the first 7 days after transplantation (not including patients in whom acute rejection of calcineurin inhibitor toxicity is proven on biopsy)
Measured: first 7 days after transplantation
Secondary outcomes (12)
Need for dialysis after transplantation
Number of dialysis sessions after transplantation
Measured: 0-30 days after transplantation
Delayed graft function
defined as the need for dialysis in the first 7 days after transplantation and preceding the return of kidney function
Measured: first 7 days after transplantation
Serum creatinine reduction ratio
alternative definition of DGF= CRR2 < or = 30%
Measured: Day 1-2 after transplantation
Graft survival
Functional kidney graft at 7 days, 3, 6, and 12 months
Measured: From 1-365 days after transplantation
Patient survival (censored and uncensored for death)
Patient survival at 7 days, 3, 6, and 12 months
Measured: From 1-365 days after transplantation
Glomerular filtration rate at 1 year after transplantation
24-hour creatinine clearance
Measured: At 1 year after transplantation (window 30 days)
Estimated glomerular filtration rate
eGFR defined by the CKD-EPI equation (Chronic Kidney Disease Epidemiology Collaboration) at 3, 6 and 12 months after transplantation
Measured: At 3, 6, and 12 months after transplantation with window of 10 days
Primary non-function
defined as the continued need for dialysis at 3 months after transplantation
Measured: Until 3 months after transplantation
Biopsy-proven acute rejection
Biopsy-proven acute rejection during the 1 year after transplantation
Measured: Until 1 year after transplantation with window of 10 days
Metabolic analysis on kidney preservation tissue
Metabolic analysis by 1D proton NMR (e.g., succinate, lactate, acetate, formate, hypoxanthine) on a tissue sample taken before (= baseline) and at the end of the preservation period before transplantation of the kidney
Measured: Baseline and pre-surgery
Metabolic analysis on kidney preservation tissue
Metabolic analysis by liquid chromatography coupled to electrospray ionization mass spectrometry (LC-ESI-MS) (succinate, glutamate, lactate, ATP, ADP, AMP, NADH, NAD+) on a tissue sample taken before (= baseline) and at the end of the preservation period before transplantation of the kidney
Measured: Baseline and pre-surgery
Metabolic analysis on preservation fluid
Metabolic analysis by 1D proton NMR and fluorescence on a perfusion fluid sample taken before (= baseline) and at the end of the preservation period before transplantation of the kidney
Measured: Baseline and pre-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start20 Mar 2022
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
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 Delayed Graft FunctionStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Kidneys originating from deceased donors after circulatory death (DCD), category 3 and 5 (controlled) will be preserved from procurement until transplantation on hypothermic machine perfusion conditions and prospectively randomized into 2 study groups: 1) intermittent surface oxygenation during HMP (surface oxygenation interrupted during organ transport (2-4h)(I-HMPO2 group), and 2) continuous surface oxygenation during HMP (surface oxygenation during the whole machine preservation period included organ transport)(C-HMPO2 group)
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tom Darius, MD, PhD, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05430620
- Sponsor's protocol ID
- 2021/21MAI/239
- Acronym
- HMPO2
- Status last verified
- May 2024
- First submitted
- 17 Jun 2022
- Last updated
- 23 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Darius T, Jochmans I, Foguenne M, Hoste E, Randon C, Bracke B, Roeyen G, Gilbo N, Weekers L, Jacobs-Tulleneers-Thevissen D, Wissing KM, Bogaerts T, Mikhalski D, De Wilde JP, Daems J, Pirenne J. Nationwide Hypothermic Machine Perfusion for ECD and DCD Kidney Transplantation in Belgium: One-Year Outcomes and Impact on Transplant Rates and Budget Impact Analysis. Transpl Int. 2025 Nov 13;38:15282. doi: 10.3389/ti.2025.15282. eCollection 2025.
PubMed 41323959
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Feasibility Trail to Compare the Efficacy of Intermittent Surface Oxygenation With Continuous Surface Oxygenation During Hypothermic Machine Perfusion of Kidneys Donated After Circulatory Death
- ClinicalTrials.gov ID
- NCT05430620
- Acronym / sponsor ID
- HMPO2 / 2021/21MAI/239
- Conditions
- Delayed Graft Function, Kidney Transplant; Complications, Ischemia Reperfusion Injury, Mitochondrial
- Keywords
- Hypothermic oxygenated machine perfusion, Kidney preservation, bubble and surface oxygenation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 20 Mar 2022 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 24 Jun 2022 (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 aim of the study is to evaluate the feasibility of this bubble and surface oxygenation and to determine the optimal timing of surface oxygenation (continuous versus intermittent) as alternative for membrane-oxygenated kidneys, originating from DCD donors, during HMP on early graft function in clinical practice.
Detailed description
Kidneys originating from deceased donors after circulatory death (DCD), category 3 and 5 (controlled) will be preserved from procurement until transplantation on hypothermic machine perfusion conditions and prospectively randomized into 2 study groups: 1) intermittent surface oxygenation during HMP (surface oxygenation interrupted during organ transport (2-4h)(I-HMPO2 group), and 2) continuous surface oxygenation during HMP (surface oxygenation during the whole machine preservation period included organ transport)(C-HMPO2 group).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Kidneys originating from deceased donors after circulatory death (DCD), category 3 and 5 (controlled) will be preserved from procurement until transplantation on hypothermic machine perfusion conditions and prospectively randomized into 2 study groups: 1) intermittent surface oxygenation during HMP (surface oxygenation interrupted during organ transport (2-4h)(I-HMPO2 group), and 2) continuous surface oxygenation during HMP (surface oxygenation during the whole machine preservation period included organ transport)(C-HMPO2 group)
| Arm | Type | Receives |
|---|---|---|
| I-HMPO2 | Experimental | Drug: Oxygenintermittent surface oxygenation during hypothermic machine perfusion (surface oxygenation interrupted during organ transport) |
| C-HMPO2 | Active comparator | Drug: Oxygencontinuous surface oxygenation during HMP (surface oxygenation during the whole machine preservation period included organ transport) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Listed for a renal transplantation due to end stage renal disease
- Willingness to comply with the protocol procedures for the duration of the study included scheduled follow-up visits and examinations.
Key exclusion criteria (2 listed)
- Multi-organ recipients
- Dual kidney transplantation
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 |
|---|---|---|
| OxygenAlso: feasibility of bubble and surface oxygenation applied to the LifePort Kidney Transporter (Organ Recovery Systems, Diegem, Belgium)Active oxygenation during hypothermic machine perfusion by bubble and surface oxygenation. Intermittent surface oxygenation is compared with continuous surface oxygenation during hypothermic machine perfusion | Drug | C-HMPO2, I-HMPO2 |
Primary outcome
Functional delayed graft function
Time frame: first 7 days after transplantation
defined as the absence of a decrease in the serum creatinine level of at least 10% per day for at least 3 consecutive days in the first 7 days after transplantation (not including patients in whom acute rejection of calcineurin inhibitor toxicity is proven on biopsy)
12 secondary outcomes
Need for dialysis after transplantation
Time frame: 0-30 days after transplantation
Delayed graft function
Time frame: first 7 days after transplantation
Serum creatinine reduction ratio
Time frame: Day 1-2 after transplantation
Graft survival
Time frame: From 1-365 days after transplantation
Patient survival (censored and uncensored for death)
Time frame: From 1-365 days after transplantation
Glomerular filtration rate at 1 year after transplantation
Time frame: At 1 year after transplantation (window 30 days)
Estimated glomerular filtration rate
Time frame: At 3, 6, and 12 months after transplantation with window of 10 days
Primary non-function
Time frame: Until 3 months after transplantation
Biopsy-proven acute rejection
Time frame: Until 1 year after transplantation with window of 10 days
Metabolic analysis on kidney preservation tissue
Time frame: Baseline and pre-surgery
Metabolic analysis on kidney preservation tissue
Time frame: Baseline and pre-surgery
Metabolic analysis on preservation fluid
Time frame: Baseline and pre-surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2024.
- Derived from this study: PubMed 41323959Darius T, Jochmans I, Foguenne M, Hoste E, Randon C, Bracke B, Roeyen G, Gilbo N, Weekers L, Jacobs-Tulleneers-Thevissen D, Wissing KM, Bogaerts T, Mikhalski D, De Wilde JP, Daems J, Pirenne J. Nationwide Hypothermic Machine Perfusion for ECD and DCD Kidney Transplantation in Belgium: One-Year Outcomes and Impact on Transplant Rates and Budget Impact Analysis. Transpl Int. 2025 Nov 13;38:15282. doi: 10.3389/ti.2025.15282. eCollection 2025.
- 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.
Tom Darius, MD, PhD principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Oxygen in people with Delayed Graft Function and Kidney Transplant; Complications, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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 2 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: status not confirmed, as of the sponsor's last update on 23 May 2024. 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 Belgium. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tom Darius, Phd (003227642218, tom.darius@saintluc.uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional delayed graft function (time frame: first 7 days after transplantation). 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 NCT05430620, 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 23 May 2024.