UK dialysis cognition study
| ISRCTN | ISRCTN45651057 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN45651057 |
| Integrated Research Application System (IRAS) | 346120 |
| Central Portfolio Management System (CPMS) | 66400 |
| Sponsor | University Hospitals Birmingham NHS Foundation Trust |
| Funder | Vantive US Healthcare |
- Submission date
- 30/10/2025
- Registration date
- 02/09/2026
- Last edited
- 02/09/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Background and study aims
This study looks at how well the brain works in people with kidney failure who are starting dialysis. Brain function—also called cognitive function—includes things like memory, learning, and decision-making. Many people on dialysis experience a decline in these abilities, especially after starting treatment. Researchers believe that this decline may happen faster in people who receive haemodialysis (HD) compared to those who receive peritoneal dialysis (PD). The aim of the study is to track changes in brain function over the first year of dialysis and compare the results between HD and PD patients.
Who can participate?
Adults aged between 18 and 80 who are starting dialysis at one of 16 centres across the UK can take part. Each centre will recruit 10 patients starting HD and 10 patients starting PD.
What does the study involve?
Participants will take part in computer-based tests to measure brain function before starting dialysis, and again at 3, 6, and 12 months. These tests are done using a system called Cogstate. The study will also look at other aspects of health, such as frailty, physical ability, and quality of life. Researchers will also collect routine information about dialysis treatment from hospital records. All personal information will be removed before the data is stored and analysed.
What are the possible benefits and risks of participating?
There are no direct medical benefits to participants, but the study may help improve understanding of how dialysis affects brain function. This could help future patients choose the type of dialysis that best supports their long-term brain health. The risks are minimal, as the tests are non-invasive and involve answering questions on a computer.
Where is the study run from?
University Hospitals Birmingham NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
May 2025 to August 2028.
Who is funding the study?
Vantive US Healthcare (USA)
Who is the main contact?
DOPPSUKDCstudy@uhb.nhs.uk
Contact information
Scientific, Principal investigator
Department of Renal Medicine and Hypertension
Heartlands Hospital, Bordesley Green East
Birmingham
B9 5SS
United Kingdom
 ORCID ID |
0000-0002-7448-2677 |
|---|---|
| Phone | +44 7866620718 |
| indranil.dasgupta@uhb.nhs.uk |
Public
Heartlands Hospital, Bordesley Green East
Birmingham
B9 5SS
United Kingdom
| DOPPSUKDCstudy@uhb.nhs.uk |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Prospective observational comparative cohort study |
| Secondary study design | Cohort study |
| Participant information sheet | 48324 UKDC PIS v5.0 16 July 2025 Clean.pdf |
| Scientific title | A comparative study of cognitive decline in end-stage kidney disease patients commencing peritoneal dialysis and haemodialysis in the UK |
| Study acronym | UKDC |
| Study objectives | Primary objective: To assess if PD is associated with better preservation of cognitive function, as measured by a cognitive function battery, compared to HD in incident ESKD patients over 12 months, using two well-characterised cohorts of patients from the Dialysis Outcomes & Practice Patterns Study (DOPPS) and the Peritoneal Dialysis Outcomes and Practice Patterns (PDOPPS) study in the UK. Secondary objective: To assess the association between cognitive decline with frailty scores over 12 months between HD and PD for incident ESKD patients. |
| Ethics approval(s) |
Approved 08/05/2025, Yorkshire and Humber - Leeds East (2 Redman Place, Stratford, E20 1JQ, United Kingdom; +44 207 104 8012; leedseast.rec@hra.nhs.uk), ref: 25/YH/0041 |
| Health condition(s) or problem(s) studied | Cognitive function in end stage kidney disease |
| Methodology | The participants will be assessed at baseline, 3, 6, and 12 months for assessment of their cognitive function. At 0, 6 and 12 months they will also be assessed for frailty, activities of daily living, depression and quality of life. The assessments will be done during their routine visits for dialysis (for haemodialysis patients) or outpatient patient appointment (for peritoneal dialysis patients). There will be no extra research visits. Routinely collected laboratory test results will be extracted from the electronic health records. The total duration of observation will be 12 months and the maximum duration of follow up will be 24 months. |
| Intervention type | Other |
| Primary outcome measure(s) |
Composite cognitive score measured using a computerised cognitive function battery (Cogstate) at baseline and 12 months |
| Key secondary outcome measure(s) |
Frailty score measured using Rockwood Frailty Score at baseline and 12 months |
| Completion date | 31/08/2028 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 80 Years |
| Sex | All |
| Target sample size at registration | 320 |
| Key inclusion criteria | 1. Age ≥45 years of age 2. End Stage Kidney Disease 3. Incident patients on haemodialysis or peritoneal dialysis |
| Key exclusion criteria | 1. Unable to give informed consent 2. History of neuropsychiatric disorder, dementia, cerebrovascular disease (stroke), or cancer (except skin cancers) 3. Use of sedatives and psychotropic drugs 4. Previous renal replacement therapy (kidney transplantation, PD, or HD) 5. Patients receiving home haemodialysis 6. Patients who have a live donor transplant planned within 6 months |
| Date of first enrolment | 01/11/2025 |
| Date of final enrolment | 31/08/2026 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centres
Mindelsohn Way
Edgabaston
Birmingham
B15 2TH
England
Stoke-on-trent
ST4 6QG
England
Clifford Bridge Road
Coventry
CV2 2DX
England
Infirmary Square
Leicester
LE1 5WW
England
Derby Road
Nottingham
NG7 2UH
England
Herries Road
Sheffield
S5 7AU
England
Pond Street
London
NW3 2QG
England
80 Newark Street
London
E1 2ES
England
London
EC3R 8AJ
England
Southwick Hill Road
Cosham
Portsmouth
PO6 3LY
England
Wrythe Lane
Carshalton
SM5 1AA
England
London
SE1 7EH
England
Manchester
M13 9WL
England
Headley Way
Headington
Oxford
OX3 9DU
England
Stott Lane
Salford
M6 8HD
England
Fulwood
Preston
PR2 9HT
England
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan | Anonymised individul particiapnt data will be shared, on application, with other researchers for use in ethics approved research projects |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 5.0 | 16/07/2025 | 31/10/2025 | No | Yes |
Additional files
- 48324 UKDC PIS v5.0 16 July 2025 Clean.pdf
- Participant information sheet
Editorial Notes
30/10/2025: Trial's existence confirmed by NHS HRA.
