Kidney Transplant FailurePhase 2APOLLONCT04882254
Normothermic Machine Perfusion: an Additional Value for Kidney Transplant Outcomes?
A Phase 2 study testing Normothermic machine perfusion in people with Kidney Transplant Failure and Chronic Kidney Failure, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
This study is a randomised, controlled, phase II trial to assess the efficacy of 2 hours normothermic machine perfusion (NMP) of extended criteria(EC)-DBD (donation after brain death) and DCD (donation after circulatory death) donor kidneys compared to standard care, which is hypothermic machine perfusion (HMP) only… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant Failure, Chronic Kidney Failure
- What is being tested?
- Normothermic machine perfusion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 May 2021to May 2025
- Phase
- Phase 2
- 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
- kidney-only transplant
- renal replacement therapy at time of transplant
- receiving standard immunosuppression regimen post-transplant.
- Donation after circulatory death (DCD) Maastricht type III, IV, or V or extended criteria donation after brain death (DBD) donor kidneys.
Who cannot join
- pre-emptive at time of transplant
- receive a multi-organ or dual kidney transplant
- age donor or recipient below 18 years
- Maastricht type I and II DCD
- donor kidneys preserved on static cold storage (SCS)
- kidneys retrieved after normothermic regional perfusion (NRP)
- Recipient virtual panel reactive antibodies ≥85%
- Recipient for who it is agreed in advance that dialysis after transplant is required, such as in the context of hyperoxaluria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Normothermic Machine Perfusion as Additional Value to Hypothermic Machine Perfusion for Kidney Transplant Outcomes. A Single-centre, Open-label, Randomised, Controlled Trial.
This study is a randomised, controlled, phase II trial to assess the efficacy of 2 hours normothermic machine perfusion (NMP) of extended criteria(EC)-DBD (donation after brain death) and DCD (donation after circulatory death) donor kidneys compared to standard care, which is hypothermic machine perfusion (HMP) only in the Netherlands.
- Conditions
- Kidney Transplant Failure, Chronic Kidney Failure
- Being tested
- Normothermic machine perfusion
- Keywords
- Normothermic kidney machine perfusion
- 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.
Normothermic machine perfusionProcedure or surgery
Additional 2h of normothermic machine perfusion of the donor kidney with a red cell based perfusate.
| Study group | Role | What they receive |
|---|---|---|
| Normothermic machine perfusion | Experimental | Additional 2 hours of normothermic machine perfusion of donor kidney with a red cell based perfusate. Receives: Procedure: Normothermic machine perfusion |
| Standard-of-care | No intervention | Standard-of-care, which is hypothermic kidney machine perfusion in the Netherlands. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with immediate graft function
Immediate graft function, which is defined as no delayed graft function and/or no primary non-function of the kidney graft.
Measured: 3 months
Secondary outcomes (5)
Duration of delayed graft function
Measured: 3 months
estimated glomerular filtration rate (eGFR) trajectory in the first year post-transplant
Measured: 1 year
Number of patients with biopsy-proven acute rejection (BPAR) within the first year post-transplant
Measured: 1 year
all-cause and death-censored graft survival up to 5 years
Measured: 5 years
patient survival up to 5 years
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2021
- Study start1 May 2021
- Primary completion6 May 2024
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Kidney Transplant FailureStudies of the same condition, open and under way.
- More trials run by Erasmus 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 randomised to either intervention arm (normothermic machine perfusion, NMP) or standard-of-care (hypothermic machine perfusion, HMP)
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Minnee, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04882254
- Sponsor's protocol ID
- APOLLO
- Acronym
- APOLLO
- Status last verified
- May 2024
- First submitted
- 6 May 2021
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lin H, Bousnina K, Slagter JS, Fang Y, Cristoferi I, Garrelds IM, Danser AHJ, Reinders MEJ, Minnee RC, Hoogduijn MJ. (Pro)renin, Erythropoietin, Vitamin D and Urodilatin Release From Human Donor Kidneys During Normothermic Machine Perfusion: Predictors of Early Post-Transplant Outcome? Clin Transplant. 2025 May;39(5):e70163. doi: 10.1111/ctr.70163.
PubMed 40278798Tingle SJ, Thompson ER, Figueiredo RS, Moir JA, Goodfellow M, Talbot D, Wilson CH. Normothermic and hypothermic machine perfusion preservation versus static cold storage for deceased donor kidney transplantation. Cochrane Database Syst Rev. 2024 Jul 9;7(7):CD011671. doi: 10.1002/14651858.CD011671.pub3.
PubMed 38979743Rijkse E, Bouari S, Kimenai HJAN, de Jonge J, de Bruin RWF, Slagter JS, van den Hoogen MWF, IJzermans JNM, Hoogduijn MJ, Minnee RC. Additional Normothermic Machine Perfusion Versus Hypothermic Machine Perfusion in Suboptimal Donor Kidney Transplantation: Protocol of a Randomized, Controlled, Open-Label Trial. Int J Surg Protoc. 2021 Oct 6;25(1):227-237. doi: 10.29337/ijsp.165. eCollection 2021.
PubMed 34708171
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Normothermic Machine Perfusion as Additional Value to Hypothermic Machine Perfusion for Kidney Transplant Outcomes. A Single-centre, Open-label, Randomised, Controlled Trial.
- ClinicalTrials.gov ID
- NCT04882254
- Acronym / sponsor ID
- APOLLO / APOLLO
- Conditions
- Kidney Transplant Failure, Chronic Kidney Failure
- Keywords
- Normothermic kidney machine perfusion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 6 May 2024 (actual)
- Study completion
- May 2025 (estimated)
- First posted
- 11 May 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.
This study is a randomised, controlled, phase II trial to assess the efficacy of 2 hours normothermic machine perfusion (NMP) of extended criteria(EC)-DBD (donation after brain death) and DCD (donation after circulatory death) donor kidneys compared to standard care, which is hypothermic machine perfusion (HMP) only in the Netherlands.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1:1 randomised to either intervention arm (normothermic machine perfusion, NMP) or standard-of-care (hypothermic machine perfusion, HMP)
| Arm | Type | Receives |
|---|---|---|
| Normothermic machine perfusion | Experimental | Procedure: Normothermic machine perfusionAdditional 2 hours of normothermic machine perfusion of donor kidney with a red cell based perfusate. |
| Standard-of-care | No intervention | –Standard-of-care, which is hypothermic kidney machine perfusion in the Netherlands. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- kidney-only transplant
- renal replacement therapy at time of transplant
- receiving standard immunosuppression regimen post-transplant.
- Donation after circulatory death (DCD) Maastricht type III, IV, or V or extended criteria donation after brain death (DBD) donor kidneys.
Key exclusion criteria (8 listed)
- pre-emptive at time of transplant
- receive a multi-organ or dual kidney transplant
- age donor or recipient below 18 years
- Maastricht type I and II DCD
- donor kidneys preserved on static cold storage (SCS)
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 |
|---|---|---|
| Normothermic machine perfusionAdditional 2h of normothermic machine perfusion of the donor kidney with a red cell based perfusate. | Procedure or surgery | Normothermic machine perfusion |
Primary outcome
Number of patients with immediate graft function
Time frame: 3 months
Immediate graft function, which is defined as no delayed graft function and/or no primary non-function of the kidney graft.
5 secondary outcomes
Duration of delayed graft function
Time frame: 3 months
estimated glomerular filtration rate (eGFR) trajectory in the first year post-transplant
Time frame: 1 year
Number of patients with biopsy-proven acute rejection (BPAR) within the first year post-transplant
Time frame: 1 year
all-cause and death-censored graft survival up to 5 years
Time frame: 5 years
patient survival up to 5 years
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
- Derived from this study: PubMed 40278798Lin H, Bousnina K, Slagter JS, Fang Y, Cristoferi I, Garrelds IM, Danser AHJ, Reinders MEJ, Minnee RC, Hoogduijn MJ. (Pro)renin, Erythropoietin, Vitamin D and Urodilatin Release From Human Donor Kidneys During Normothermic Machine Perfusion: Predictors of Early Post-Transplant Outcome? Clin Transplant. 2025 May;39(5):e70163. doi: 10.1111/ctr.70163.
- Derived from this study: PubMed 38979743Tingle SJ, Thompson ER, Figueiredo RS, Moir JA, Goodfellow M, Talbot D, Wilson CH. Normothermic and hypothermic machine perfusion preservation versus static cold storage for deceased donor kidney transplantation. Cochrane Database Syst Rev. 2024 Jul 9;7(7):CD011671. doi: 10.1002/14651858.CD011671.pub3.
- Derived from this study: PubMed 34708171Rijkse E, Bouari S, Kimenai HJAN, de Jonge J, de Bruin RWF, Slagter JS, van den Hoogen MWF, IJzermans JNM, Hoogduijn MJ, Minnee RC. Additional Normothermic Machine Perfusion Versus Hypothermic Machine Perfusion in Suboptimal Donor Kidney Transplantation: Protocol of a Randomized, Controlled, Open-Label Trial. Int J Surg Protoc. 2021 Oct 6;25(1):227-237. doi: 10.29337/ijsp.165. eCollection 2021.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Normothermic machine perfusion in people with Kidney Transplant Failure and Chronic Kidney Failure, run by Erasmus Medical Center at 1 site 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 8 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 7 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 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
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?
Number of patients with immediate graft function (time frame: 3 months). 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 NCT04882254, which also lists 3 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 May 2024.