Quality assessment of kidneys by ex-vivo warm perfusion prior to transplantation

Quality assessment of human kidneys by ex-vivo normothermic perfusion prior to transplantation

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN91315246

Enrollment

Registered

2016-06-29

Start date

2015-12-21

Completion date

Unknown

Last updated

2022-09-05

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

Kidneys declined for transplantation will be offered into this research study by NHSBT. If they meet the inclusion criteria they will be transplanted into a suitable recipient. The pa

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Kidneys declined for transplantation by several transplant centres and by all the fast-track transplant centres due to adverse donor characteristics, prolonged ischaemia, gross appearance, histological changes (excluding cancer), and cold perfusion parameters. 2. Donor and recipient age = 18 years 3. Patient undergoing a 1st or 2nd renal transplant from a deceased donor 4. Written, signed informed consent to the procedure

Exclusion criteria

Exclusion criteria: 1: Kidneys that are deemed unsuitable for transplantation due to contraindications defined by current NHSBT criteria . 2: Kidneys with irreparable vascular damage. 3: Recipients of a 3rd or subsequent transplant.

Design outcomes

Primary

Measure	Time frame
Graft function after transplantation is assessed by measuring serum creatinine levels over the first seven days post-transplant then one and three months after transplantation.	—

Secondary

Measure	Time frame
1. Rates of delayed graft function (DGF), defined as the need for dialysis within the first 7 days after transplant. Episodes of dialysis will be recorded and the need for dialysis assessed by measuring levels of creatinine in the blood. Samples will be taken daily 2. Slow graft function rate (SGF), defined as a less than 10% reduction in serum creatinine levels within for 3 consecutive days after transplantation, is measured using serum creatinine levels in the blood. Samples will be taken daily for 7 days post-transplant. 3. Rates of primary non function (PNF), defined as the graft never functioning, is measured using levels of creatinine in the blood. 4. Episodes of acute rejection within the first 3 months are diagnosed by taking a tissue sample from the kidney. 5. Adverse reactions e.g. infection, thrombosis of the graft will be recorded 6. Length of hospital stay is measured by calculating the number of days the patient remains in hospital after the transplant 7. Perfusion parameters during perfusion of the kidney (renal blood flow, urine output) 8. Histopathology, molecular markers measured in tissue samples taken from the kidney before after the transplant will be performed during the transplant procedure 9. Quality of life is measured using the Kidney disease Quality of Life – short form at baseline (before transplant) and 3 months post-transplant Long-term secondary outcomes: 1. Graft function after transplantation is assessed by measuring serum creatinine levels at 6 and 12 months 2. Renal function is measured by determining eGFR levels at 6 and 12 months 3. Number of rejection episodes is diagnosed by taking a tissue sample from the kidney over 12 months 4. Incidences of graft loss is measured by recording the failure of the graft over 12 months	—

Measure

Time frame

1. Rates of delayed graft function (DGF), defined as the need for dialysis within the first 7 days after transplant. Episodes of dialysis will be recorded and the need for dialysis assessed by measuring levels of creatinine in the blood. Samples will be taken daily 2. Slow graft function rate (SGF), defined as a less than 10% reduction in serum creatinine levels within for 3 consecutive days after transplantation, is measured using serum creatinine levels in the blood. Samples will be taken daily for 7 days post-transplant. 3. Rates of primary non function (PNF), defined as the graft never functioning, is measured using levels of creatinine in the blood. 4. Episodes of acute rejection within the first 3 months are diagnosed by taking a tissue sample from the kidney. 5. Adverse reactions e.g. infection, thrombosis of the graft will be recorded 6. Length of hospital stay is measured by calculating the number of days the patient remains in hospital after the transplant 7. Perfusion parameters during perfusion of the kidney (renal blood flow, urine output) 8. Histopathology, molecular markers measured in tissue samples taken from the kidney before after the transplant will be performed during the transplant procedure 9. Quality of life is measured using the Kidney disease Quality of Life – short form at baseline (before transplant) and 3 months post-transplant Long-term secondary outcomes: 1. Graft function after transplantation is assessed by measuring serum creatinine levels at 6 and 12 months 2. Renal function is measured by determining eGFR levels at 6 and 12 months 3. Number of rejection episodes is diagnosed by taking a tissue sample from the kidney over 12 months 4. Incidences of graft loss is measured by recording the failure of the graft over 12 months

—

Countries

England, United Kingdom

Contacts

Public ContactSarah Hosgood

sh744@cam.ac.uk+44 1223 762002

Outcome results

None listed

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