Anakinra for gout flares in kidney disease: a feasibility trial that missed its recruitment target

Design

Double-blind, double-dummy randomised feasibility trial

Population

21 people with gout flares and chronic kidney disease (eGFR below 60)

Primary outcome

Feasibility: recruitment, enrolment, crossover and assessment completion

Effect

Overall success criteria not met (under-recruitment); mean 7-day pain reduction 46.8 mm across the cohort

ASGARD was a double-blind, double-dummy feasibility trial at four UK centres comparing subcutaneous anakinra 100 mg daily for five days with intramuscular methylprednisolone acetate 120 mg for gout flares in people with chronic kidney disease (eGFR below 60).

It did not meet its overall success criteria because of under-recruitment. Twenty-one participants were randomised (mean age 72, mean eGFR 44) and 17 received per-protocol treatment. Procedural criteria were met: at least 70% of eligible patients enrolled, 10% or fewer crossovers or treatment failures, and 85% completed five of seven pain assessments. Mean pain reduction at 7 days was 46.8 mm on a 100 mm scale across the cohort, and anakinra appeared to give a shorter time to pain reduction, which needs a larger trial.

With 21 patients there are no comparative effect estimates here. The practical context is that colchicine and NSAIDs are often limited in kidney disease and steroid alternatives are of interest, but this study cannot tell you which to use.

• Treat this as a feasibility result, not a comparison of efficacy.
• A shorter time to pain relief with anakinra was a hint, needing confirmation.
• Questionnaire burden and treatment delays were participants' main complaints.
• Manage flares in kidney disease with existing guidance until larger trials report.

Why it matters

It shows how hard it is to recruit for gout flare trials in kidney disease, a group with few safe options.

Don't overread it

Missed its recruitment target; no formal comparison of efficacy was possible.

The statistics, in plain English

A feasibility trial asks whether a larger trial could be run, not which treatment works better. With 21 patients, any apparent difference between arms is likely to be noise.

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