Kidney DiseaseOK-POPNCT07419945
Older Kidney Patient Optimisation Pretransplant
A study testing Kidney transplant-specific comprehensive geriatric assessment in people with Kidney Disease and Kidney Failure, run by Guy's and St Thomas' NHS Foundation Trust.
Trial summary
The goal of this clinical trial is to learn if a kidney transplant-specific comprehensive geriatric assessment (KT-CGA) can improve the way older adults are assessed for kidney transplantation. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Kidney Disease, Kidney Failure, Frailty
- What is being tested?
- Kidney transplant-specific comprehensive geriatric assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 2 Feb 2026to 2 Feb 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 60 years or older
- Attending Guy's and St Thomas' (GSTT) Nephrology services
- Diagnosed with Chronic Kidney Disease (CKD) Stage 5
- Either:
- Pre-dialysis, or
- Receiving dialysis (in-centre haemodialysis, peritoneal dialysis, or home haemodialysis)
- Referred to the kidney transplant surgical clinic for assessment of suitability for kidney transplantation (pre-transplant evaluation)
Who cannot join
- Adults aged under 60 years
- Patients currently attending the Nephrology Supportive Care service at GSTT
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Optimising Access to and Outcomes From Transplantation in Older Potential Kidney Transplant Recipients: Pilot Feasibility Study on Kidney Transplant-specific Comprehensive Geriatric Assessment (KT-CGA)
The goal of this clinical trial is to learn if a kidney transplant-specific comprehensive geriatric assessment (KT-CGA) can improve the way older adults are assessed for kidney transplantation. The main questions it aims to answer are:
Is it feasible and acceptable to deliver a KT-CGA alongside routine transplant assessment in older adults with advanced kidney disease?
Read more
What is the effect of KT-CGA on decision-making about transplant listing and on patient-reported outcomes such as quality of life and frailty?
Researchers will compare participants who receive the KT-CGA plus usual care to those who receive usual care alone.
Participants will:
Continue with their usual transplant assessment process
If randomised to the intervention group, also complete the KT-CGA (a structured set of questionnaires, short memory and function tests, and discussions about wellbeing and support needs, taking about 45-60 minutes)
Read the detailed description
Older adults with advanced chronic kidney disease (CKD) are increasingly being assessed for kidney transplantation. However, multimorbidity, frailty, and cognitive impairment are highly prevalent in this population and may influence transplant eligibility, perioperative risk, recovery trajectories, and longer-term outcomes. Current transplant assessment pathways are not routinely designed to systematically identify or address these geriatric syndromes.
Comprehensive Geriatric Assessment (CGA) is a structured, multidimensional process that evaluates medical, functional, cognitive, psychological, and social domains, with the aim of informing personalised care planning and optimisation. CGA has demonstrated benefit in older surgical and oncological populations, but its feasibility and impact within kidney transplant assessment pathways remain uncertain.
The OK-POP study is a single-centre, randomised controlled feasibility trial evaluating the integration of a kidney transplant-specific CGA (KT-CGA) into routine outpatient transplant assessment at Guy's and St Thomas' NHS Foundation Trust. Participants undergoing transplant assessment are randomised in a 1:1 ratio to either usual transplant assessment care or usual care supplemented by KT-CGA delivered by a clinician trained in geriatric principles.
The primary focus of the study is to assess the feasibility and acceptability of delivering KT-CGA within an established transplant assessment pathway. This includes evaluation of recruitment and retention processes, completeness of study assessments, fidelity of KT-CGA delivery, and acceptability to both patients and clinical staff.
Secondary objectives explore the clinical, service-level, and patient-centred consequences of KT-CGA, including its influence on transplant assessment processes, optimisation actions triggered by assessment findings, healthcare utilisation, and longer-term clinical and patient-reported outcomes. Outcomes are collected longitudinally over a two-year follow-up period to characterise trajectories before and after transplant listing and, where applicable, transplantation.
The study also incorporates a preliminary health economic evaluation to explore the feasibility of estimating costs and outcomes associated with KT-CGA. Pseudonymised data are securely shared with King's College London to support exploratory analyses of healthcare utilisation and quality-adjusted life years, informing the design of a future definitive economic evaluation.
Findings from this feasibility trial will inform the refinement of the KT-CGA intervention, outcome selection, and trial procedures, and will be used to support the design of a future multicentre randomised controlled trial evaluating the effectiveness and cost-effectiveness of KT-CGA in older kidney transplant candidates.
- Conditions
- Kidney Disease, Kidney Failure, Frailty, Cognitive Impairment, Multimorbidity, End Stage Kidney Disease (ESRD)
- Being tested
- Kidney transplant-specific comprehensive geriatric assessment
- Keywords
- kidney transplant, frailty, multimorbidity, cognitive impairment, end stage kidney disease, health inequality
- Medical subject headings
- Kidney Diseases, Renal Insufficiency, Frailty, Cognitive Dysfunction, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kidney transplant-specific comprehensive geriatric assessmentOther
KT-CGA is an adaptation of the standard Comprehensive Geriatric Assessment (CGA), a multidimensional, interdisciplinary evaluation designed to identify and address medical, functional, psychological, and social factors that influence outcomes in older adults. Like conventional CGA, KT-CGA includes structured assessments of frailty, cognition, mood, mobility, activities of daily living, comorbidity, and social support.
KT-CGA incorporates elements specific to advanced kidney disease and transplantation, including review of renal history, dialysis modality, and suitability for renal replacement therapies. It emphasises optimisation: medication reconciliation, health promotion, and onward referral to relevant specialties or allied health professionals as indicated.
It is delivered in the outpatient setting by an experienced renal clinician with oversight from a consultant geriatrician trained in perioperative CGA and a consultant nephrologist.
| Study group | Role | What they receive |
|---|---|---|
| Kidney transplant-specific CGA | Experimental | This arm will receive KT-CGA (single clinic visit lasting 45-60 minutes with multidimensional assessment of frailty, multimorbidity, cognition, renal disease/treatment and function). Receives: Other: Kidney transplant-specific comprehensive geriatric assessment |
| Standard pre-transplant care | No intervention | This arm will receive usual pre-transplant evaluation and care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of eligible patients who consented and were randomised
Proportion of eligible patients approached for participation who provided written informed consent and were subsequently randomised.
Measured: From first eligible patient approached through completion of recruitment (anticipated 12 months)
Proportion of participants allocated to KT-CGA who completed the full assessment
Proportion of participants randomised to the intervention arm who completed all predefined components of the kidney transplant-specific comprehensive geriatric assessment (KT-CGA).
Measured: At intervention visit (single study visit following randomisation, within 4 weeks of allocation)
Duration of KT-CGA visit
Mean duration of the KT-CGA intervention visit, measured in minutes from start to completion of assessment.
Measured: At intervention visit (single study visit following randomisation, within 4 weeks of allocation)
Reach of KT-CGA
Proportion of eligible participants who received KT-CGA among those randomised to the intervention arm.
Measured: From first intervention delivered through completion of recruitment (anticipated 12 months)
Fidelity of KT-CGA delivery
Proportion of predefined KT-CGA protocol components delivered per participant, assessed using a structured fidelity checklist.
Measured: At intervention visit (single study visit following randomisation, within 4 weeks of allocation)
Participant acceptability of randomisation and KT-CGA
Participant-reported acceptability measured using Likert-scale responses (e.g., 1-5 scale) assessing views on randomisation, intervention experience, and follow-up procedures.
Measured: Immediately post-intervention visit (same day as KT-CGA visit)
Secondary outcomes (23)
Days Alive and Out of Hospital at 180 days (DAOH-180)
DAOH-180 will be calculated as the number of days alive and not spent in hospital during the 180-day follow-up period.
Measured: 180 days from index date (date of KT-CGA for intervention group; equivalent index clinic date for control group)
Kidney transplant waitlisting status
Proportion of participants placed on the kidney transplant waiting list (absolute number and expressed as percentage).
Measured: 6 months, 12 months, and 24 months after index study visit
Kidney transplantation status
Proportion of participants who receive a kidney transplant during follow-up (absolute number and expressed as percentage).
Measured: 12 months and 24 months after index study visit
Length of hospital stay associated with kidney transplantation
Total length of inpatient hospital stay associated with kidney transplantation, measured in days from date of transplant admission to date of hospital discharge, among participants who undergo transplantation during the study period.
Measured: From transplant admission through hospital discharge (hospital stay, up to 30 days post-transplant)
Number of investigations requested
Total number of diagnostic investigations requested per participant during pre-transplant evaluation and follow-up (count).
Measured: Up to 24 months after index study visit
Kidney graft survival
Graft survival defined as absence of graft failure requiring return to dialysis or death due to kidney failure among transplanted participants (Time-to-event (months) / Proportion surviving).
Measured: 12 months and 24 months after transplantation
Overall survival
Survival status of participants during follow-up (Time-to-event (months) / Proportion surviving).
Measured: 12 months and 24 months after index study visit
Days Alive and Out of Hospital at 365 days (DAOH-365)
Number of days participants are alive and not hospitalised during the 365-day follow-up period.
Measured: 365 days after index study visit
Days Alive and Out of Hospital at 730 days (DAOH-730)
Number of days participants are alive and not hospitalised during the 730-day follow-up period.
Measured: 730 days after index study visit
New diagnoses or clinical findings following KT-CGA
Number of new diagnoses or previously unrecognised clinical findings identified following completion of KT-CGA (Count).
Measured: Up to 6 months after KT-CGA
Medication changes prompted by KT-CGA
Number of medication changes initiated following KT-CGA, including new prescriptions, dose adjustments, and deprescribing (Count).
Measured: Up to 6 months after KT-CGA
Therapy referrals initiated following KT-CGA
Number of referrals to allied health professionals (e.g., physiotherapy, occupational therapy, dietetics, speech and language therapy, or social work) initiated following KT-CGA (Count).
Measured: Up to 6 months after KT-CGA
Lifestyle advice provided following KT-CGA
Number of instances in which lifestyle advice (e.g., smoking cessation, alcohol reduction, weight management, sleep hygiene, continence advice) is documented following KT-CGA (Count).
Measured: Up to 6 months after KT-CGA
Multispecialty referrals or investigations prompted by KT-CGA
Number of multispecialty referrals or additional investigations initiated following KT-CGA, beyond standard pre-transplant assessment (Count).
Measured: Up to 6 months after KT-CGA
Shared decision-making discussions following KT-CGA
Number of documented shared decision-making discussions following KT-CGA, including assessment of decision-making capacity and discussion of benefits, risks, alternatives, and non-transplant options (Count).
Measured: Up to 6 months after KT-CGA
Long-term condition management actions following KT-CGA
Number of management actions for long-term conditions initiated following KT-CGA, including new outpatient referrals and documented advice to primary or specialty care teams (Count).
Measured: Up to 6 months after KT-CGA
Advance care planning actions following KT-CGA
Number of advance care planning actions documented following KT-CGA, including treatment escalation planning, cardiopulmonary resuscitation decisions, or discussion of lasting power of attorney (Count).
Measured: Up to 6 months after KT-CGA
Opportunity cost measured by healthcare utilisation
Healthcare utilisation associated with pre-transplant and post-transplant care, measured by the number of investigation requests and specialty referrals initiated, including referrals made pre-emptively following KT-CGA compared with referrals made during unplanned inpatient admissions (Counts).
Measured: Up to 24 months after index study visit
Change in health-related quality of life (EQ-5D-5L) at 12 months
Change in health-related quality of life measured using the EQ-5D-5L questionnaire.
Measured: Baseline and 12 months after index study visit
Change in Clinical Frailty Scale (CFS) score at 12 months
Change in frailty score from baseline to 12 months, measured using the Clinical Frailty Scale (CFS). The CFS is a 9-point ordinal scale, with higher scores indicating greater frailty.
Measured: Baseline and 12 months after randomisation
Change in Edmonton Frail Scale (EFS) score at 12 months
Change in frailty score from baseline to 12 months, measured using the Edmonton Frail Scale (EFS). The EFS is a multidimensional frailty assessment tool with scores ranging from 0 to 17, with higher scores indicating greater frailty.
Measured: Baseline and 12 months after randomisation
Change in Montreal Cognitive Assessment (MoCA) score at 12 months
Change in cognitive assessment score from baseline to 12 months, measured using the Montreal Cognitive Assessment (MoCA). The MoCA is a 30-point screening tool, with lower scores indicating greater cognitive impairment.
Measured: Baseline and 12 months after randomisation
Change in Rowland Universal Dementia Assessment Scale (RUDAS) score at 12 months
Change in cognitive assessment score from baseline to 12 months, measured using the Rowland Universal Dementia Assessment Scale (RUDAS). The RUDAS is a 30-point cognitive screening tool, with lower scores indicating greater cognitive impairment.
Measured: Baseline and 12 months after randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start2 Feb 2026 (estimated)
- Primary completion2 Feb 2027 (estimated)
- Study completion2 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a feasibility study examining KT-CGA in patients aged over 60 being worked up for kidney transplantation. It is a single-centre, unblinded randomised control trial.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London
- Responsible party
- Sponsor
- Investigators
- Antonia J Cronin, MBBS MA PhD, Principal investigator, Guy's and St Thomas' NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07419945
- Sponsor's protocol ID
- 358879
- Acronym
- OK-POP
- Status last verified
- Feb 2026
- First submitted
- 7 Jan 2026
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided