The HOPE machine for preserving kidney transplants trial
| ISRCTN | ISRCTN96735894 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN96735894 |
| IRAS number | 273420 |
| Secondary identifying numbers | IRAS 273420, CPMS 47480 |
- Submission date
- 24/01/2021
- Registration date
- 27/01/2021
- Last edited
- 08/02/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Background and study aims
A kidney transplant is the transfer of a healthy kidney from one person into the body of a person who has little or no kidney function. The main role of the kidneys is to filter waste products from the blood and convert them to wee. If the kidneys lose this ability, waste products can build up, which is potentially life-threatening.
Kidney transplantation remains the therapy of choice for patients with end stage kidney disease. However, the number of patients waiting for a kidneys continues to increase and far exceeds the availability of donors which has pushed transplant centres to consider less ideal organ donors. Donation after circulatory death (DCD) i.e. cardiac arrest, currently represents 45% of deceased donors in the UK and 20% in Switzerland.
Due to the delay between cardiac arrest and start of cold flush prior to procurement; DCD kidneys are more prone to develop delayed graft function (DGF) which is defined as the need for dialysis within the first 7 days after transplantation with rates as high as 55-60%.
To overcome these disadvantages of DCD organs, new concepts of organ preservation such as machine perfusion have been introduced. Machine perfusion has demonstrated superiority over conventional cold storage being associated with lower DGF and improved 1 and 3 year transplant kidney survival rate. The addition of Oxygen to cold machine perfusion is known to improve outcomes in liver transplantation and pre-clinical data suggests similar effects on transplanted kidneys.
Who can participate?
Adults over 18 years, who have received a DCD kidney transplant.
What does the study involve?
In this trial we aim to put different methods of DCD organ preservation in a comparison including oxygenated cold machine perfusion, simple cold machine perfusion and static cold storage to investigate any additional benefit of combining oxygenation and cold machine perfusion. The participants will be consented and will require follow up over a period of 12 months post operatively including blood tests
What are the possible benefits and risks of participating?
There are no risks from participating as there is no deviation from the routine care and follow up protocol and the results will help shape the future of organ preservation as well as provide an opportunity for the participants to gain access to this new technology.
Where is the study run from?
1. St. James’s University Hospital, Leeds (UK)
2. University Hospital, Zurich (Switzerland)
When is the study starting and how long is it expected to run for?
October 2019 to February 2025
Who is funding the study?
1. Organ Recovery Systems (USA)
2. Kidney Research UK
3. Leeds Hospital Charities (UK)
Who is the main contact?
Dr Philipp Kron (scientific), philipp.kron@usz.ch
Mr Ahmed Ghoneima (public), ahmed.seif.ghoneima@doctors.org.uk
Contact information
Scientific
Department of Surgery and Transplantation
University Hospital Zurich
Raemistrasse 100
Zurich
8091
Switzerland
 ORCID ID |
0000-0002-6074-7072 |
|---|---|
| Phone | +41 764614879 |
| philipp.kron@usz.ch |
Public
Level 6, Bexley Wing
St. James's University Hospitals
Beckett Street
Leeds
LS9 7TF
United Kingdom
| Phone | +44 (0)7827128271 |
|---|---|
| ahmed.seif.ghoneima@doctors.org.uk |
Study information
| Study design | Multicentre interventional non-randomized study with matched historical control cohorts |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | Hypothermic Oxygenated PErfusion for DCD KIDNEY Grafts: A Multi-centre Trial |
| Study acronym | HOPE for KIDNEYS |
| Study objectives | Oxygenated Cold Machine Perfusion techniques improve outcomes of kidney transplants from DCD grafts by reducing the rates of delayed graft function i.e. promoting immediate functioning of the kidneys after transplant and reducing the need of dialysis in the short term after transplant. |
| Ethics approval(s) | Approval pending, East Midlands - Leicester Central Research Ethics Committee (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS, UK; +44 (0)207 104 8388; leicestercentral.rec@hra.nhs.uk), ref: 20/EM/0276 |
| Health condition(s) or problem(s) studied | Delayed graft function (DGF) in kidney transplant from donation after cardiac death (DCD) |
| Intervention | This will be a 3 arm study and follow up will be over 12 months for all participants and historical cohorts: -HOPE arm: Kidneys will be preserved using Hypothermic Machine Perfusion + Oxygen treatment for which patients will be recruited and data will be collected prospectively -HMP arm: Kidneys will have been preserved using Hypothermic Machine Perfusion without Oxygen. This is a historical treatment group -SCS arm: Kidneys will have been preserved using Static Cold Storage (Ice Box). This is a historical control group as this is the most common current practice |
| Intervention type | Mixed |
| Primary outcome measure | Rate of Delayed Graft Function will be assessed by the monitoring the requirement of Renal Replacement Therapy (dialysis) within 1 week of transplant |
| Secondary outcome measures | Data for the HOPE arm will be collected in specifically designed Case report Files (CRFs) while data for the historical groups will be collected from Hospital Databases and Electronic Records 1. Duration in days and Number of Dialysis Sessions will be calculated between Transplant and achievement of graft Function 2. Creatinine reduction ratio between Day 0 and Day 7 of less than 70 percent 3. Length of hospital stay in days 4. Rates of biopsy proven rejections within 12 months of transplant 5. Incidence of complications according to the Clavien-Dindo Classification within 90 days from Transplant 6. Serum Creatinine Levels, eGFR and Creatinine Clearance at 30 days, 90 days and 12 months from Transplant 7. Death Censored Graft Survival and Patient Death at 12 months from Transplant 8. Analysis of Perfusion Fluid for: 8.1. Markers of Kidney injury using NGAL and creatinine in plasma samples 8.2. Oxidative damage of DNA will be analyzed in perfusate and plasma by 8-hydroxy-2-deoxy Guanosine (8-OHdG) 8.3. Nuclear injury will be measured by release of high mobility group box protein-1 8.4. Quantitative real-time polymerase chain reaction (PCR) will be performed if possible (TaqMan gene expression assays) for Toll-like receptor (TLR)-4, tumor necrosis factor-alpha (TNF-[alpha]), high mobility group box-1 protein (HMGB-1), von Willebrand factor (vWF), endothelin 1 (Edn-1), Hepatocyte growth factor |
| Overall study start date | 14/10/2019 |
| Completion date | 21/02/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 146 |
| Key inclusion criteria | 1. Age ≥18 years 2. DCD grafts 3. Primary kidney transplantation 4. Single kidney transplantation 5. Signed informed Consent |
| Key exclusion criteria | 1. DBD graft 2. Dual kidney transplantation 3. Kidney re-transplantation 4. Multi-organ transplantation 5. Perfusion of the organ not possible due to technical problems |
| Date of first enrolment | 01/03/2022 |
| Date of final enrolment | 28/02/2024 |
Locations
Countries of recruitment
- England
- Switzerland
- United Kingdom
Study participating centres
Beckett Street
Leeds
LS9 7TF
United Kingdom
Zurich
8091
Switzerland
Sponsor information
Hospital/treatment centre
Research and Innovation Building
St. James's University Hospitals
Beckett Street
Leeds
LS9 7TF
England
United Kingdom
| Phone | +44 (0)7827128271 |
|---|---|
| anne.gowing@nhs.net | |
| Website | http://www.leedsth.nhs.uk/home/ |
Funders
Funder type
Industry
No information available
Private sector organisation / Other non-profit organizations
- Location
- United Kingdom
No information available
Results and Publications
| Intention to publish date | 01/03/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Results will be presented at National and International Conferences and Scientific Meetings (e.g. BTS, ESOT .... etc.) as well as publishing results in high-impact peer-reviewed journals. |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version v0.7 | 02/12/2020 | 27/01/2021 | No | No |
| HRA research summary | 28/06/2023 | No | No |
Additional files
- ISRCTN96735894_PROTOCOL_v0.7_02Dec2020.docx
- uploaded 27/01/2021
Editorial Notes
08/02/2022: The following changes have been made:
1. The recruitment end date has been changed from 31/03/2023 to 28/02/2024.
2. The overall trial end date has been changed from 31/03/2024 to 21/02/2025 and the plain English summary has been updated to reflect this change.
3. The intention to publish date has been changed from 01/04/2024 to 01/03/2025.
07/02/2022: The following changes have been made:
1. The recruitment start date has been changed from 01/04/2021 to 01/03/2022.
2. Leeds Hospital Charities has been added as a funder and the plain English summary has been updated accordingly.
27/01/2021: Uploaded protocol (not peer reviewed) Version 0.7, 2 December 2020.
26/01/2021: Trial’s existence confirmed by Organ Recovery Systems.
