Older Kidney Patient Optimisation Pretransplant

NCT07419945 | Not Yet Recruiting

• 1 other identifier: 358879
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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. 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)

Conditions

Kidney Disease; End Stage Kidney Disease (ESRD); Kidney Failure; Frailty; Cognitive Impairment; Multimorbidity; Kidney Transplant; Health Inequity

Keywords

kidney transplant; frailty; multimorbidity; cognitive impairment; end stage kidney disease; health inequality

Outcome Measures

Primary Outcomes (6)

• 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.

  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).

  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.

  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.

  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.

  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.

  Immediately post-intervention visit (same day as KT-CGA visit)

Secondary Outcomes (23)

• Days Alive and Out of Hospital at 180 days (DAOH-180)

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

• Kidney transplant waitlisting status

  6 months, 12 months, and 24 months after index study visit

• Kidney transplantation status

  12 months and 24 months after index study visit

• Length of hospital stay associated with kidney transplantation

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

• Number of investigations requested

  Up to 24 months after index study visit

Study Arms (2)

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).

Other: Kidney transplant-specific comprehensive geriatric assessment

Standard pre-transplant care

NO INTERVENTION

This arm will receive usual pre-transplant evaluation and care.

Interventions

Kidney transplant-specific comprehensive geriatric assessment OTHER

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.

Kidney transplant-specific CGA

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Adults aged under 60 years
• Patients currently attending the Nephrology Supportive Care service at GSTT

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead
• King's College London: collaborator

MeSH Terms

Conditions

Kidney Diseases; Renal Insufficiency; Frailty; Cognitive Dysfunction; Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Renal Insufficiency, Chronic; Chronic Disease; Disease Attributes

Study Officials

• Antonia J Cronin, MBBS MA PhD

  Guy's and St Thomas' NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

John A Holland, MB BCh BAO

CONTACT

+447307073144; john.holland9@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 7, 2026
• First Posted: February 19, 2026
• Study Start: February 2, 2026
• Primary Completion (Estimated): February 2, 2027
• Study Completion (Estimated): February 2, 2028
• Last Updated: February 19, 2026

Record last verified: 2026-02