Transplant;Failure,KidneyREMO-HYMAPNCT04619732
Real-time Monitoring of Kidney Grafts on Hypothermic Machine Perfusion
A study testing Monitoring biochemical concentrations during cold machine perfusion in people with Transplant;Failure,Kidney, run by Accunea Ltd. at 1 site in United Kingdom.
Trial summary
A significant number of deceased donor kidneys donated for transplantation are not used and are thrown away due to lack of ways of checking their condition and function before the operation. This significantly reduces the number of potentially life saving transplants. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Transplant;Failure,Kidney
- What is being tested?
- Monitoring biochemical concentrations during cold machine perfusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jul 2021to 30 Apr 2023
- 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
- All organs to be used in the study must be intended for transplantation and not already rejected/discarded.
- All organs must be sourced from deceased donors through NHSBT in the normal course of clinical activity.
- Kidneys must come from marginal or 'imperfect' donors according to current clinical criteria. This typically indicates an age of 60 and over, or 50 and over with one or more premorbid conditions, including renal impairment, cerebrovascular disease, and hypertension.
Who cannot join
- Organs from living donors are excluded.
- Organs from young healthy donors are excluded.
- Organs will be excluded if on the assessment of the clinical team they are not suitable for hypothermic machine perfusion. This indicates organs that have arrived with visible defects, or fall well outside the team's standard criteria for clinical acceptability (excessive time in transit, excessive warm ischaemia time, excessive cold ischaemia time, very poor pre-morbid donor condition).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Hammersmith Hospital
London, W12 0HS
Becky Ward, 02075949459, becky.ward@imperial.ac.uk
Vassilios E Papalois, MD PhD
About this study
Official title: A Clinical Pilot Study Investigating the Real-time Dynamics of Glucose, Lactate and Creatinine Concentrations in Marginal Donor Kidneys Undergoing Hypothermic Machine Perfusion
A significant number of deceased donor kidneys donated for transplantation are not used and are thrown away due to lack of ways of checking their condition and function before the operation. This significantly reduces the number of potentially life saving transplants.
The researchers wish to run a small pilot study to see if it is possible to improve the way transplant kidneys are assessed before transplantation by measuring how well they filter the blood, and how good their metabolism is. The researchers believe this new method will help transplant surgeons make better decisions about which kidneys to use.
Read more
This pilot study will look at 10 kidneys obtained from older deceased donors. These kidneys are most at risk of being thrown away because of the condition of the donor they came from. At the hospital, these kidneys are usually put onto a machine which pumps cold preservation solution through them for a couple of hours. This time lets the transplant surgeons see how well or poorly the kidney responds to the flowing fluid.
In this study the research team will do exactly the same, but also insert a small probe less than a millimetre in diameter into the kidney and the vein (draining blood pipe) and urine output to monitor a number of chemicals made by the kidney. The researchers believe that the changing levels of these chemicals will give the surgeons much more information than they have now. This probe is removed when the kidney is transplanted.
Combining these levels with news of how well the patients recover after surgery will allow the research team to design a much larger study to get the right level of information to change the way surgeons choose kidneys and help more transplants happen in the future.
- Conditions
- Transplant;Failure,Kidney
- Being tested
- Monitoring biochemical concentrations during cold machine perfusion
- Keywords
- creatinine, microdialysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monitoring biochemical concentrations during cold machine perfusionDiagnostic test
Three microdialysis probes will be introduced into the kidney tissues, the vein and ureter in order to measure creatinine, glucose and lactate while the organ is undergoing cold perfusion prior to transplantation.
| Study group | Role | What they receive |
|---|---|---|
| Marginal Kidneys | Experimental | Transplant patients receiving kidneys from deceased marginal donors: aged >= 60, or >= 50 with comorbid renal impairment, hypertension, or cerebrovascular disease.
Following consent, kidneys will be cold perfused with preserving solution for 2-4 hours as per standard of care at the study centre. During this period, the kidneys will be monitored for creatinine, glucose, and lactate concentrations using three microdialysis probes placed into the tissue, the vein, and the ureter. Data will be blinded to clinicians.
The probes will be removed at the end of the perfusion period and the organs will be transplanted or discarded according to clinical protocol. If transplanted, the study will monitor the patient's recovery for the first 30 days. Receives: Diagnostic Test: Monitoring biochemical concentrations during cold machine perfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative recovery of kidney function
Magnitude of change in patient baseline serum creatinine concentration pre- and post-operatively at 30 days (in umol/L)
Measured: 30 days post-operatively
Secondary outcomes (5)
Reintervention rate
Any need to return the patient to theatre or perform additional procedures following the transplant
Measured: 30 days post-operatively
Primary non-function
Number of participants with no change in serum creatinine concentration from baseline despite transplantation
Measured: 30 days post-operatively
Delayed graft function
Number of days with inadequate graft function following surgery (low urine output, static serum creatinine concentration)
Measured: 30 days post-operatively
Acute rejection
Number of patients experiencing immunological rejection of the organ
Measured: 30 days post-operatively
Post-operative complications
Rates of the most common complications including arterial, venous, or parenchymal thrombosis, ureteric leak or stenosis
Measured: 30 days post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2020
- Study start1 Jul 2021
- Primary completion30 Apr 2023 (estimated)
- Study completion30 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transplant;Failure,KidneyStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Accunea Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Imperial College Healthcare NHS Trust
- Responsible party
- Sponsor
- Investigators
- Vassilios Papalois, MD PhD, Principal investigator, Imperial College Healthcare NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04619732
- Sponsor's protocol ID
- REMO-HYMAP 2020
- Acronym
- REMO-HYMAP
- Status last verified
- May 2022
- First submitted
- 2 Nov 2020
- Last updated
- 31 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share non-anonymised patient data with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Pilot Study Investigating the Real-time Dynamics of Glucose, Lactate and Creatinine Concentrations in Marginal Donor Kidneys Undergoing Hypothermic Machine Perfusion
- ClinicalTrials.gov ID
- NCT04619732
- Acronym / sponsor ID
- REMO-HYMAP / REMO-HYMAP 2020
- Conditions
- Transplant;Failure,Kidney
- Keywords
- creatinine, microdialysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Accunea Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Imperial College Healthcare NHS Trust
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 30 Apr 2023 (estimated)
- First posted
- 6 Nov 2020 (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.
A significant number of deceased donor kidneys donated for transplantation are not used and are thrown away due to lack of ways of checking their condition and function before the operation. This significantly reduces the number of potentially life saving transplants.
The researchers wish to run a small pilot study to see if it is possible to improve the way transplant kidneys are assessed before transplantation by measuring how well they filter the blood, and how good their metabolism is. The researchers believe this new method will help transplant surgeons make better decisions about which kidneys to use.
This pilot study will look at 10 kidneys obtained from older deceased donors. These kidneys are most at risk of being thrown away because of the condition of the donor they came from. At the hospital, these kidneys are usually put onto a machine which pumps cold preservation solution through them for a couple of hours. This time lets the transplant surgeons see how well or poorly the kidney responds to the flowing fluid.
In this study the research team will do exactly the same, but also insert a small probe less than a millimetre in diameter into the kidney and the vein (draining blood pipe) and urine output to monitor a number of chemicals made by the kidney. The researchers believe that the changing levels of these chemicals will give the surgeons much more information than they have now. This probe is removed when the kidney is transplanted.
Combining these levels with news of how well the patients recover after surgery will allow the research team to design a much larger study to get the right level of information to change the way surgeons choose kidneys and help more transplants happen in the future.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Marginal Kidneys | Experimental | Diagnostic Test: Monitoring biochemical concentrations during cold machine perfusionTransplant patients receiving kidneys from deceased marginal donors: aged >= 60, or >= 50 with comorbid renal impairment, hypertension, or cerebrovascular disease. Following consent, kidneys will be cold perfused with preserving solution for 2-4 hours as per standard of care at the study centre. During this period, the kidneys will be monitored for creatinine, glucose, and lactate concentrations using three microdialysis probes placed into the tissue, the vein, and the ureter. Data will be blinded to clinicians. The probes will be removed at the end of the perfusion period and the organs will be transplanted or discarded according to clinical protocol. If transplanted, the study will monitor the patient's recovery for the first 30 days. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All organs to be used in the study must be intended for transplantation and not already rejected/discarded.
- All organs must be sourced from deceased donors through NHSBT in the normal course of clinical activity.
- Kidneys must come from marginal or 'imperfect' donors according to current clinical criteria. This typically indicates an age of 60 and over, or 50 and over with one or more premorbid conditions, including renal impairment, cerebrovascular disease, and hypertension.
Key exclusion criteria (3 listed)
- Organs from living donors are excluded.
- Organs from young healthy donors are excluded.
- Organs will be excluded if on the assessment of the clinical team they are not suitable for hypothermic machine perfusion. This indicates organs that have arrived with visible defects, or fall well outside the team's standard criteria for clinical acceptability (excessive time in transit, excessive warm ischaemia time, excessive cold ischaemia time, very poor pre-morbid donor condition).
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 |
|---|---|---|
| Monitoring biochemical concentrations during cold machine perfusionThree microdialysis probes will be introduced into the kidney tissues, the vein and ureter in order to measure creatinine, glucose and lactate while the organ is undergoing cold perfusion prior to transplantation. | Diagnostic test | Marginal Kidneys |
Primary outcome
Post-operative recovery of kidney function
Time frame: 30 days post-operatively
Magnitude of change in patient baseline serum creatinine concentration pre- and post-operatively at 30 days (in umol/L)
5 secondary outcomes
Reintervention rate
Time frame: 30 days post-operatively
Primary non-function
Time frame: 30 days post-operatively
Delayed graft function
Time frame: 30 days post-operatively
Acute rejection
Time frame: 30 days post-operatively
Post-operative complications
Time frame: 30 days post-operatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2022.
- Individual participant dataSharing planned: No. No plan to share non-anonymised patient data with other researchers.
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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.
Vassilios Papalois, MD PhD principal investigator
Imperial College Healthcare NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monitoring biochemical concentrations during cold machine perfusion in people with Transplant;Failure,Kidney, run by Accunea Ltd. at 1 site in United Kingdom.
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 3 inclusion and 3 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 31 May 2022. 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 United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robert M Learney, MBBS PhD (02088741839, robertlearney@accunea.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative recovery of kidney function (time frame: 30 days post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 May 2022.