The HOPE machine for preserving kidney transplants trial

Hypothermic Oxygenated PErfusion for DCD KIDNEY Grafts: A Multi-centre Trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN96735894

Enrollment

146

Registered

2021-01-27

Start date

2022-03-01

Completion date

Unknown

Last updated

2022-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delayed graft function (DGF) in kidney transplant from donation after cardiac death (DCD) Urological and Genital Diseases

Interventions

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 +

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age =18 years 2. DCD grafts 3. Primary kidney transplantation 4. Single kidney transplantation 5. Signed informed Consent

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Rate of Delayed Graft Function will be assessed by the monitoring the requirement of Renal Replacement Therapy (dialysis) within 1 week of transplant	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

England, Switzerland, United Kingdom

Contacts

Public ContactAhmed Ghoneima

ahmed.seif.ghoneima@doctors.org.uk+44 (0)7827128271

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026