End Stage Renal DiseasePROPERNCT04693325
PROlonged Ex-vivo Normothermic Machine PERfusion for Kidney Regeneration
A study testing Prolonged normothermic machine perfusion in people with End Stage Renal Disease, run by Leiden University Medical Center at 2 sites in Netherlands.
Trial summary
The investigators would like to introduce and clinically evaluate prolonged normothermic machine perfusion (PNMP) to preserve and assess high-risk donor kidneys prior to transplantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- Prolonged normothermic machine perfusion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesNetherlands
- Study dates
- 1 Dec 2021to Jan 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing 1st or 2nd kidney transplant
- Patients undergoing a kidney transplantation from DCD Maastricht III \& V
- Transplant recipients aged ≥ 18 years
- Written informed consent
Who cannot join
- Patients undergoing 3rd or subsequent kidney transplant
- Patients undergoing a kidney transplantation from DCD Maastricht I, II \& IV
- Transplant recipients aged < 18 years
- Patients receiving multi-organ transplants
- ABO/HLA incompatible transplants
- Highly sensitized patients with a panel-reactive antibody (PRA) ≥85%
Show all 9Show fewer
- Kidneys with CIT > 12 hrs at the point of arrival at transplant centre
- Kidneys with complex vascular anatomy (≥3 arteries, artery which cannot be can-nulated or attached to the patch holder)
- Kidneys explanted from a donor on normothermic regional perfusion
Trial locations and contacts
2 sites in 1 country.
Dorottya K De Vries, MD PhD contact
Netherlands2 sites, 2 recruiting
- Recruiting
University Medical Center Groningen
Groningen
Robert A Pol, MD PhD, r.pol@umcg.nl
Robert A Pol, MD PhD
- Recruiting
Leiden University Medical Center
Leiden
Asel Arykbaeva, a.s.arykbaeva@lumc.nl
About this study
The investigators would like to introduce and clinically evaluate prolonged normothermic machine perfusion (PNMP) to preserve and assess high-risk donor kidneys prior to transplantation.
Read the detailed description
Currently kidney transplantation is the only viable option for patients with kidney failure to regain quality of life and health. The number of organs available for transplantation is insufficient with a widening gap between supply and demand. Nowadays, centers accept older and higher risk donor organs with co-morbidity, often leading to non-function, complications and with half of the patients back on dialysis within 15 years. Furthermore, many donor kidneys have to be discarded as too damaged and beyond repair. Increasing the quality and therefore transplantability of these high-risk donor organs could significantly increase the donor kidney pool.
Using prolonged normothermic perfusion of marginal donor organs, the investigators aim to kick start regeneration in the kidney before transplantation, improving function and survival long-term. Furthermore, the choice to accept or decline a donor kidney organ is currently based on subjective criteria and causes great uncertainty amongst clinicians. There is a dire need for tools to aid in decision making and reduce this uncertainty. Biomarkers predictive of graft regeneration are lacking. Samples from perfused kidneys and donor recipients will be collected and analysed to allow the formulation of a kidney fitness index.
- Conditions
- End Stage Renal Disease
- Being tested
- Prolonged normothermic machine perfusion
- Keywords
- normothermic machine perfusion, renal transplantation, kidney transplantation
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prolonged normothermic machine perfusionProcedure or surgery
First, a cohort of DCD kidneys (n=6) will be subjected to 1 hour of NMP and subsequently transplanted [NMP1]. Before extending the duration, secondary endpoints will be evaluated. Thereafter, the duration of NMP will be prolonged to 3 hours (n=6) [PNMP3] and consequently 6 hours (n=6) [PNMP6].
| Study group | Role | What they receive |
|---|---|---|
| Prolonged normothermic machina perfusion | Experimental | Eligible and consenting patients who will receive a donor kidney will be included for participation in this study. Current practice is to preserve donor kidneys on hypothermic machine perfusion (HMP). In this study, donor kidneys (n=18) will be taken off the HMP after arrival in the transplant center. These will then be perfused with oxygenated perfusate using the NMP device following an optimised NMP protocol. Receives: Procedure: Prolonged normothermic machine perfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
glomerular filtration rate (GFR)
renal function defined by the estimated glomerular filtration rate (eGFR) calculated with the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation
Measured: 6 months post transplantation
Secondary outcomes (7)
glomerular filtration rate (GFR)
renal function defined by the estimated glomerular filtration rate (eGFR) calculated with the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation
Measured: 1 month post transplantation
glomerular filtration rate (GFR)
renal function defined by the estimated glomerular filtration rate (eGFR) calculated with the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation
Measured: 3 months post transplantation
primary non-function
defined as permanent lack of graft function from the time of transplantation, was diagnosed when a kidney graft was well perfused (confirmed by ultrasound examination) but never functioned, necessitating dialysis after kidney transplantation
Measured: 6 months post transplantation
delayed graft function (DGF)
defined as the need for postoperative dialysis during the first 7 days after transplantation
Measured: 6 months post transplantation
patient and graft survival
time from transplant to patient death, and graft failure
Measured: 6 months post transplantation
adverse events
defined as any undesirable experience occurring to a subject during the study, whether or not considered related to the normothermic machine perfusion of the donor kidney prior to transplantation
Measured: 6 months post transplantation
postoperative complications
graded according to the comprehensive complication index
Measured: 6 months post transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start1 Dec 2021
- Primary completionJul 2022 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ipjalwayn, Leiden University Medical Center
- Investigators
- Ian PJ Alwayn, MD PhD, Principal investigator, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04693325
- Sponsor's protocol ID
- NL76344
- Acronym
- PROPER
- Status last verified
- Dec 2021
- First submitted
- 24 Jun 2020
- Last updated
- 3 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROlonged Ex-vivo Normothermic Machine PERfusion for Kidney Regeneration
- ClinicalTrials.gov ID
- NCT04693325
- Acronym / sponsor ID
- PROPER / NL76344
- Conditions
- End Stage Renal Disease
- Keywords
- normothermic machine perfusion, renal transplantation, kidney transplantation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 5 Jan 2021 (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 investigators would like to introduce and clinically evaluate prolonged normothermic machine perfusion (PNMP) to preserve and assess high-risk donor kidneys prior to transplantation.
Detailed description
Currently kidney transplantation is the only viable option for patients with kidney failure to regain quality of life and health. The number of organs available for transplantation is insufficient with a widening gap between supply and demand. Nowadays, centers accept older and higher risk donor organs with co-morbidity, often leading to non-function, complications and with half of the patients back on dialysis within 15 years. Furthermore, many donor kidneys have to be discarded as too damaged and beyond repair. Increasing the quality and therefore transplantability of these high-risk donor organs could significantly increase the donor kidney pool.
Using prolonged normothermic perfusion of marginal donor organs, the investigators aim to kick start regeneration in the kidney before transplantation, improving function and survival long-term. Furthermore, the choice to accept or decline a donor kidney organ is currently based on subjective criteria and causes great uncertainty amongst clinicians. There is a dire need for tools to aid in decision making and reduce this uncertainty. Biomarkers predictive of graft regeneration are lacking. Samples from perfused kidneys and donor recipients will be collected and analysed to allow the formulation of a kidney fitness index.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prolonged normothermic machina perfusion | Experimental | Procedure: Prolonged normothermic machine perfusionEligible and consenting patients who will receive a donor kidney will be included for participation in this study. Current practice is to preserve donor kidneys on hypothermic machine perfusion (HMP). In this study, donor kidneys (n=18) will be taken off the HMP after arrival in the transplant center. These will then be perfused with oxygenated perfusate using the NMP device following an optimised NMP protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients undergoing 1st or 2nd kidney transplant
- Patients undergoing a kidney transplantation from DCD Maastricht III \& V
- Transplant recipients aged ≥ 18 years
- Written informed consent
Key exclusion criteria (9 listed)
- Patients undergoing 3rd or subsequent kidney transplant
- Patients undergoing a kidney transplantation from DCD Maastricht I, II \& IV
- Transplant recipients aged < 18 years
- Patients receiving multi-organ transplants
- ABO/HLA incompatible transplants
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 |
|---|---|---|
| Prolonged normothermic machine perfusionFirst, a cohort of DCD kidneys (n=6) will be subjected to 1 hour of NMP and subsequently transplanted [NMP1]. Before extending the duration, secondary endpoints will be evaluated. Thereafter, the duration of NMP will be prolonged to 3 hours (n=6) [PNMP3] and consequently 6 hours (n=6) [PNMP6]. | Procedure or surgery | Prolonged normothermic machina perfusion |
Primary outcome
glomerular filtration rate (GFR)
Time frame: 6 months post transplantation
renal function defined by the estimated glomerular filtration rate (eGFR) calculated with the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation
7 secondary outcomes
glomerular filtration rate (GFR)
Time frame: 1 month post transplantation
glomerular filtration rate (GFR)
Time frame: 3 months post transplantation
primary non-function
Time frame: 6 months post transplantation
delayed graft function (DGF)
Time frame: 6 months post transplantation
patient and graft survival
Time frame: 6 months post transplantation
adverse events
Time frame: 6 months post transplantation
postoperative complications
Time frame: 6 months post transplantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2022.
- 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.
Dorottya K De Vries, MD PhD contact
Ian PJ Alwayn, MD PhD principal investigator
Leiden University Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prolonged normothermic machine perfusion in people with End Stage Renal Disease, run by Leiden University Medical Center at 2 sites in Netherlands.
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 4 inclusion and 9 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 3 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. 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 Asel Arykbaeva (+31657216416, a.s.arykbaeva@lumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
glomerular filtration rate (GFR) (time frame: 6 months post transplantation). 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 3 Jan 2022.