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Improving function of transplanted kidneys

A randomised controlled trial of Ex-Vivo Normothermic Perfusion versus static cold storage in donation after circulatory death renal transplantation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN15821205
Enrollment
400
Registered
2016-02-10
Start date
2016-02-13
Completion date
Unknown
Last updated
2023-06-05

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

Conditions

Kidney transplantation Urological and Genital Diseases

Interventions

After the identification of a suitable DCD kidney and matched recipient, the patient will be called into the transplant centre. Once assessed and the inclusion criteria met, the patient will be given

Sponsors

Cambridge University Hospitals NHS Foundation trust & University of Cambridge
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients undergoing DCD kidney transplantation (Maastricht Categories III & IV) 2. DCD donor aged 18 years or over 3. Transplant recipients aged 18 years or over 4. First or second kidney transplant recipients

Exclusion criteria

Exclusion criteria: 1. DCD donors aged under 18 years 2. DCD donors in Maastricht Categories I & II 3. Third and subsequent kidney transplant recipients 4. Multi-organ transplants e.g. simultaneous pancreas-kidney transplantation 5. Dual kidney transplants 6. Paediatric en-bloc kidney transplants 7. Organ preservation by hypothermic machine perfusion

Design outcomes

Primary

MeasureTime frame
Delayed graft function rate is determined by the need for dialysis in the first 7 days post-transplant.

Secondary

MeasureTime frame
1. Primary non-function (PNF), defined as the permanent lack of allograft function from the time of transplantationincluding graft losses due to irreversible rejection and vascular thrombosis, is recorded along with the cause at the end of the trial (12 months) 2. Duration of DGF is measured by recording the number of sessions and days that the recipient requires dialysis after transplantation in days 3. Functional DGF (fDGF), defined as <10% fall in serum creatinine for 3 consecutive days, is measured using blood analysis in the first week post-transplant 4. Creatinine reduction ratio (CRR2 = creatinine day 1 – creatinine day 2/ creatinine day 1) is measured using blood analysis on day 2 5. Creatinine reduction ratio (CRR 5 = pre transplant creatinine - creatinine day 5/ pre-transplant creatinine) is measured using blood analysis on day 5 6. Length of hospital stay is measured as the number of days the recipient remains in hospital after the transplant 7. Biopsy-proven acute rejection rates is measured through examination of kidney biopsy samples when acute rejection is suspected 8. Serum creatinine and eGFR is measured using blood and urine analysis at baseline (pre-transplant), 1, 3, 6 and 12 months 9. Patient survival (time from transplant to death) is measured in days 10. Allograft survival (time from transplant to graft loss or return to dialysis) is measured in days

Countries

England, United Kingdom

Contacts

Public ContactSarah Hosgood

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 27, 2026