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Cytokine removal in kidney transplantation

A randomised pilot study to assess the safety and feasibility of adding a Cytosorb filter during kidney normothermic machine perfusion.

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN13698207
Enrollment
20
Registered
2024-02-06
Start date
2025-01-01
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

Kidney transplantation from deceased donors. Surgery

Interventions

Prospective kidney transplant recipients on the waiting list at a single centre (Cambridge University Hospitals NHS Foundation Trust), who are eligible to participate in this study, will be approached

Sponsors

University of Cambridge
Lead Sponsor
Cambridge University Hospitals NHS Foundation Trust
Collaborator

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: Current inclusion criteria as of 17/06/2025: 1. Patients receiving a kidney from donation after brain death (DBD) and/or donation after circulatory death (DCD) donor =50 years 2. Transplant recipients aged =18 years 3. Patients undergoing a 1st or 2nd kidney transplant 4. Patients who have given written informed consent Previous inclusion criteria: 1. Patients receiving a kidney from donation after brain death (DBD) and/or donation after circulatory death (DCD) donor =50 years 2. Transplant recipients aged =18 years 3. Patients undergoing a 1st or 2nd kidney transplant 4. Patients who have given written informed consent 5. Patients who are receiving renal replacement therapy

Exclusion criteria

Exclusion criteria: Current exclusion criteria as of 17/06/2025: 1. Patient receiving a kidney from DCD and DBD donor <50 years old 2. Patients receiving a 3rd or subsequent kidney transplant 3. Patients receiving multi-organ transplants e.g. simultaneous pancreas-kidney transplantation 4. Patients receiving dual kidney transplants 5. Paediatric en-bloc kidney transplants 6. Kidneys with complex vascular anatomy Previous exclusion criteria: 1. Patient receiving a kidney from DCD and DBD donor <50 years old 2. Patients receiving a 3rd or subsequent kidney transplant 3. Patients receiving multi-organ transplants e.g. simultaneous pancreas-kidney transplantation 4. Patients receiving dual kidney transplants 5. Paediatric en-bloc kidney transplants 6. Patients that are pre-dialysis 7. Kidneys with complex vascular anatomy

Design outcomes

Primary

MeasureTime frame
Inflammatory and immune gene expression measured in cortical biopsy from the kidney 60 minutes post-transplant

Secondary

MeasureTime frame
1. Rates of delayed graft function, defined as the requirement for dialysis in the first 7 days post-transplant 2. Duration of delayed graft function, measured from the first to the last episode of dialysis post-transplant 3. Incidence of primary non function, defined as a non-functioning graft up to 3 months post-transplant 4. Graft function at 3 months post-transplant measured by levels of serum creatinine and estimated glomerular filtration rate (eGFR) 5. Incidences of biopsy-proven rejection measured by histopathology up to 3 months post-transplant 6. Complications (infection, re-operation due to bleeding) recorded up to 3 months post-transplant 7. The length of hospital stay post-transplant 8. Levels of inflammation/immune and injury markers measured in the perfusate and urine collected from the kidney during NMP (pre, 2, 4 and 6 h). Samples will be analysed using ELISA techniques 9. Isolation of peripheral blood mononuclear cells blood samples collected pre-transplant and on day 1 and day 5 post-transplant 10. Biomarkers of kidney injury measured by ELISA using plasma samples collected from the patients on day 1 and day 5 post-transplant

Countries

England, United Kingdom

Contacts

Public ContactSarah Hosgood
sh744@cam.ac.uk+44 1223 763105

Outcome results

None listed

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