Older Kidney Patient Optimisation Pretransplant

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorGuy's and St Thomas' NHS Foundation Trust

About this trial

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?

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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged 60 years or older

Attending Guy's and St Thomas' (GSTT) Nephrology services

Diagnosed with Chronic Kidney Disease (CKD) Stage 5

Pre-dialysis, or

Disqualifiers

Adults aged under 60 years

Patients currently attending the Nephrology Supportive Care service at GSTT

Trial design

Design model

Parallel

Treatments tested in this trial

  • Kidney transplant-specific comprehensive geriatric assessment

    Other intervention

    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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Kidney transplant-specific CGAExperimental treatment 1 intervention
Group B: Standard pre-transplant careNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
From first eligible patient approached through completion of recruitment (anticipated 12 months)
2

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).

Time frame
At intervention visit (single study visit following randomisation, within 4 weeks of allocation)
3

Duration of KT-CGA visit

Mean duration of the KT-CGA intervention visit, measured in minutes from start to completion of assessment.

Time frame
At intervention visit (single study visit following randomisation, within 4 weeks of allocation)
4

Reach of KT-CGA

Proportion of eligible participants who received KT-CGA among those randomised to the intervention arm.

Time frame
From first intervention delivered through completion of recruitment (anticipated 12 months)

Secondary outcomes

1

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.

Time frame
180 days from index date (date of KT-CGA for intervention group; equivalent index clinic date for control group)
2

Kidney transplant waitlisting status

Proportion of participants placed on the kidney transplant waiting list (absolute number and expressed as percentage).

Time frame
6 months, 12 months, and 24 months after index study visit
3

Kidney transplantation status

Proportion of participants who receive a kidney transplant during follow-up (absolute number and expressed as percentage).

Time frame
12 months and 24 months after index study visit
4

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.

Time frame
From transplant admission through hospital discharge (hospital stay, up to 30 days post-transplant)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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