Does the introduction of a national pre-implantation biopsy histopathology service increase numbers, and improve outcomes, of kidney transplants performed in the UK?

Pre-Implantation Trial of Histopathology In renal Allografts (PITHIA)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN11708741

Enrollment

2306

Registered

2018-01-30

Start date

2018-03-01

Completion date

Unknown

Last updated

2025-09-08

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

Conditions

Surgery for renal failure Urological and Genital Diseases Surgery

Interventions

Access to national histopathology service: the service is implemented according to the trial's stepped-wedge cluster randomized design. Once a centre has access to the service, they can request a kidn

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Kidneys offered for transplantation from deceased donors (DCD* and DBD**) aged =60 years

Exclusion criteria

Exclusion criteria: Kidneys offered as a component of a multi-organ transplant

Design outcomes

Primary

Measure	Time frame
1. Proportion of kidneys that are transplanted on first offer 2. Estimated glomerular filtration rate (eGFR) measured at 12-15 months after transplant	—

Secondary

Measure	Time frame
Primary and secondary outcome data will be measured using data from the UK Transplant Registry, which is held by NHS Blood and Transplant: 1. Proportion of kidneys utilised 2. Total number of kidney transplants performed, overall and by centre 3. Proportion of kidneys discarded after retrieval, out of all retrieved kidneys 4. Number and proportion of ‘single’ vs ‘dual’ kidney transplants performed 5. Absolute number of kidneys transplanted (per centre and per time period) that were not accepted on first offer 6. Biopsy utilisation and fidelity, defined as the proportion of kidneys that are biopsied in concordance with the education plan, out of all kidney biopsies. 7. Kidney Donor Profile Index (KDPI) of transplants performed 8. Cold ischaemia time (CIT), defined as the total time between perfusion of the donor kidneys with cold preservation fluid during retrieval, and reperfusion with recipient blood at implantation. 9. 12-month patient survival 10. 12-month graft survival (censored for patient death) 11. Proportion of kidneys diagnosed with primary non-function 12. Proportion of kidneys diagnosed with delayed graft function (defined as the use of dialysis during the first postoperative week)	—

Measure

Time frame

Primary and secondary outcome data will be measured using data from the UK Transplant Registry, which is held by NHS Blood and Transplant: 1. Proportion of kidneys utilised 2. Total number of kidney transplants performed, overall and by centre 3. Proportion of kidneys discarded after retrieval, out of all retrieved kidneys 4. Number and proportion of ‘single’ vs ‘dual’ kidney transplants performed 5. Absolute number of kidneys transplanted (per centre and per time period) that were not accepted on first offer 6. Biopsy utilisation and fidelity, defined as the proportion of kidneys that are biopsied in concordance with the education plan, out of all kidney biopsies. 7. Kidney Donor Profile Index (KDPI) of transplants performed 8. Cold ischaemia time (CIT), defined as the total time between perfusion of the donor kidneys with cold preservation fluid during retrieval, and reperfusion with recipient blood at implantation. 9. 12-month patient survival 10. 12-month graft survival (censored for patient death) 11. Proportion of kidneys diagnosed with primary non-function 12. Proportion of kidneys diagnosed with delayed graft function (defined as the use of dialysis during the first postoperative week)

—

Countries

England, United Kingdom

Contacts

Public ContactEmma Laing

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 22, 2026