Preparing for responsive management versus renal dialysis in older people living with kidney failure and frailty or multimorbidity in the UK (Prepare for Kidney Care): a two-arm, superiority, parallel-group, open-label, pragmatic, phase 3, individually randomised controlled trial

BACKGROUND: The comparative effectiveness of conservative kidney management and dialysis in older people (aged ≥80 years regardless of frailty and comorbidity or aged 65-79 years if frailty or multimorbidity are present) living with kidney failure is unknown. We aimed to assess the relative effectiveness of preparing for responsive management-a protocolised version of conservative kidney management-and preparing for renal dialysis. METHODS: Prepare for Kidney Care was a two-arm, superiority, parallel-group, open-label, pragmatic, phase 3, individually randomised controlled trial conducted in 31 kidney centres in England, Wales, Scotland, and Northern Ireland. Eligible patients had an estimated glomerular filtration rate below 15 mL/min per 1·73 m FINDINGS: From July 1, 2017, to Aug 31, 2024, 6120 patients were screened across 31 kidney centres in the UK, 445 (7%) of whom were eligible and agreed to be randomly assigned. 228 (51%) of 445 participants were randomly assigned to prepare for responsive management and 217 (49%) of 445 participants were randomly assigned to prepare for renal dialysis. Median age was 82 years (IQR 80 to 86) and 137 (31%) of 445 participants were female. After a mean follow-up duration of 4·5 years (SD 2·1), mean QALYs were 1·354 (95% CI 1·201 to 1·508) in the prepare for responsive management group and 1·472 (1·288 to 1·655) in the prepare for renal dialysis group (adjusted mean difference -0·147 [95% CI -0·350 to 0·056] p=0·16). Specific harms outcomes were not prespecified, but hospital admission rates were similar in the two groups and dialysis access complications were significantly lower in the prepare for responsive management group (adjusted incident rate ratio 0·41 [95% CI 0·19 to 0·88]), based on 74 events in 36 participants across both groups. There were 667 serious adverse events in the prepare for responsive management group (157 [69%] of 228 participants died, with 510 hospital admissions) and 578 in the prepare for renal dialysis group (136 [63%] of 217 participants died, with 442 hospital admissions). None of these serious adverse events met the criteria for expedited reporting. INTERPRETATION: Among older people living with kidney failure and frailty or multimorbidity, we found no evidence that either preparing for responsive management or preparing for renal dialysis was superior in terms of QALYs over a mean follow-up duration of 4·5 years. This trial provides novel comparative information for clinical decision making.