Acute gout flares in patients with chronic kidney disease: Summary of a feasibility randomized trial of Anakinra versus methylprednisolone (intramuscular)

A UK multicenter double-blind feasibility trial compared Anakinra with intramuscular methylprednisolone for gout flares in people with chronic kidney disease; the study reported recruitment shortfalls and preliminary signals that Anakinra may relieve pain faster, but larger trials are needed to confirm this.[1]

Study type: Journal Article,Randomized Controlled Trial,Multicenter Study,Comparative Study (classification: randomized controlled trial) Published: BMJ open, 2026-09-30 Source: PubMed public abstract

A UK multicenter double-blind feasibility trial compared Anakinra with intramuscular methylprednisolone for gout flares in people with chronic kidney disease; the study reported recruitment shortfalls and preliminary signals that Anakinra may relieve pain faster, but larger trials are needed to confirm this.[1]

Why this study matters

This study (ASGARD) was a double-blind, double-dummy randomized controlled feasibility trial conducted at four secondary care centers in the UK. Its purpose was to assess whether a comparative trial of Anakinra (subcutaneous) versus intramuscular methylprednisolone acetate in people with chronic kidney disease (eGFR <60 mL/min/1.73 m2) presenting with acute gout flares is feasible, and to collect safety, economic, qualitative, and patient-reported outcome data to inform the design of a subsequent larger confirmatory trial.[1]

What the study actually found

Summary of main results (based on the public abstract)

• Recruitment and feasibility: The study did not meet its prespecified overall success criteria, mainly due to recruitment shortfalls (the original target was to recruit 32 participants within 15 months). However, at a procedural level the trial met several feasibility indicators, including consent rate (>70% of eligible patients consented to participate), treatment crossover or failure rate ≤10%, and, after excluding four participants who did not receive allocated treatment, 85% of participants completed at least five self-reported pain assessments within the first 7 days.[1]
• Participants and treatment: The abstract reports that 21 participants were randomized (mean age 72 years, mean eGFR 44 mL/min/1.73 m2), of whom 17 received treatment as planned.
• Pain and function: Overall, mean pain reduction from baseline to day 7 was a decrease of 46.8 mm on a 100 mm visual analogue scale (VAS). The abstract indicates that Anakinra appeared to reduce pain faster, but the authors emphasize that this observation requires confirmation in a larger trial.[1]
• Other outcomes: High completion rates for functional and quality-of-life questionnaires; healthcare resource use assessed from health records was higher; qualitative feedback from participants noted questionnaire burden and delays in accessing treatment.

Possible implications for patients with CKD, dialysis, or transplant

Preliminary interpretations based on the abstract

• Feasibility: The authors consider a larger randomized controlled trial feasible, but operational issues—such as recruitment shortfalls and clinical workflow problems (for example, faster assessment and treatment pathways, enhanced case finding in the community)—need to be addressed before a definitive trial can proceed.[1]
• Pain relief: Data in this small sample suggest that Anakinra may relieve pain faster, but this is a preliminary observation and cannot be regarded as confirmed efficacy or causal; a larger, adequately powered trial is required to verify this.
• Safety and resources: The trial collected safety and economic data, but the abstract does not provide detailed safety conclusions or cost-effectiveness analysis; therefore one cannot conclude from the abstract alone that either intervention is safer or more cost-effective.[1]

Current study limitations

Key limitations (based on the abstract)

• This summary is based on the PubMed public abstract and the full text was not reviewed; therefore details or additional analyses reported in the full paper may not be captured here.
• Small sample size: The abstract reports only 21 randomized participants and 17 treated per protocol, insufficient to draw definitive conclusions on efficacy or safety.
• Recruitment shortfall: Failure to meet the planned recruitment target may introduce selection bias or affect generalizability.
• Generalizability limits: The trial was conducted in four secondary care centers in the UK; applicability to other healthcare systems or to earlier (community) care settings may be limited.
• Feasibility nature: As a feasibility study, conclusions about time to pain relief, long-term safety, or cost-effectiveness require confirmation in a larger definitive trial.

Questions that remain uncertain

Areas needing further research

• Does Anakinra truly provide faster or more sustained pain relief than intramuscular methylprednisolone in acute gout flares? (requires larger trials)
• What are the comparative safety profiles and longer-term outcomes of the two treatments across varying degrees of chronic kidney disease? (the abstract lacks sufficient safety detail)
• Can case finding and rapid treatment pathways in community or primary care settings be implemented to improve recruitment and reduce treatment delays?
• What are the long-term economic and resource-use implications? The abstract notes higher healthcare resource use but lacks a full cost-effectiveness assessment.
• How can participant burden from questionnaires be reduced without compromising data quality, and can treatment delays be minimized?

(All of the above are based on the abstract and require the full trial report or subsequent confirmatory studies for definitive answers.)[1]

Questions to discuss with your clinical team

• Does this study mean Anakinra has replaced corticosteroids as the preferred treatment for gout in people with chronic kidney disease? (Answer: No. This is a small feasibility trial that provides preliminary information and is not sufficient to change clinical standards or establish efficacy.)
• Does the study prove Anakinra is safer or more effective in patients with worse kidney function? (Answer: The abstract does not provide adequate safety or confirmatory efficacy data; larger randomized trials are needed.)
• I or a family member have chronic kidney disease and are having a gout flare—what should we do? (Answer: Discuss acute management with your nephrologist or rheumatologist; this abstract should not replace clinical assessment or prescription decisions. If interested in trial participation, ask your clinician or local center about similar studies.)
• What practical improvements did the trial suggest? (Answer: The authors suggest enhancing community case finding and streamlining acute-care pathways to reduce treatment delay, and considering ways to reduce questionnaire burden when designing a larger trial.)
• Does the abstract fully reflect all safety outcomes? (Answer: The abstract notes safety data were collected but does not present full details; consult the full text or later reports for a complete safety analysis.)

How to read this study (our interpretation)

This section was written by the Beyond CKD editor — a kidney-transplant recipient with a health-management background, not a physician — using only the PubMed abstract. We have not read the full paper, and no clinician has reviewed this text. It is meant to help you understand the numbers, not to advise treatment.

What the study asked

Acute gout flares are hard to treat in CKD: NSAIDs harm the kidney, colchicine needs dose reduction and steroids disturb blood sugar. ASGARD, a UK multicentre double-blind trial, compared anakinra (an IL-1 blocker, 100 mg under the skin daily for 5 days) with a single intramuscular injection of methylprednisolone 120 mg in gout patients with eGFR below 60 — but it was a feasibility study, so its main purpose was to test whether a full-scale trial could be run.

How to read the results

Read this with the right expectation: the primary outcome was recruitment and process, not which drug works better. The result was mixed. The plan was 32 participants in 15 months; only 21 were randomised (mean age 72, mean eGFR 44), so the overall feasibility target was not met. Procedural targets were met — over 70% of eligible patients enrolled, under 10% crossed over or failed treatment, and 85% completed the pain diaries. On effect, pain across both arms combined fell by a mean of 46.8 mm on a 100-mm scale over 7 days. Anakinra appeared to relieve pain faster, but the authors state this must be confirmed in a larger trial. Participants said the questionnaires were burdensome and treatment arrived too slowly.

Limitations

With 21 randomised and 17 treated per protocol, no efficacy comparison has meaningful statistical power — and a feasibility design was never meant to provide one. The abstract gives no per-arm pain figures and no detailed safety results.

What it means for readers and people with kidney disease

If you have CKD and recurrent gout, this trial cannot yet tell you that anakinra beats steroids. Its real significance is that researchers are seriously tackling a long-neglected question — what to give kidney patients during a flare — and a definitive answer may follow. For now, flare treatment should be chosen by a doctor who knows your kidney function; do not reach for NSAIDs on your own.

How to check further

Ask your doctor: Given my kidney function, which flare medicines are safe for me and which are not? Does my urate-lowering drug dose need adjusting for my eGFR?

Original abstract: PubMed 42816092 (https://pubmed.ncbi.nlm.nih.gov/42816092/). Interpretation last updated 2026-11-06.

References

[1] Balasubramaniam G, Almond M, Harnett P, Turner D, Scales J, Zhang J. Anakinra versus intramuscular methylprednisolone acetate for gout flares in people with chronic kidney disease (ASGARD): a UK randomised multicentre, double-blind, double-dummy controlled feasibility study with economic, qualitative and safety assessment.. BMJ open. 2026. DOI: 10.1136/bmjopen-2025-114454. PMID: 42816092.

Medical disclaimer: This article is for general health education and information only. It does not constitute individual medical diagnosis, treatment advice, or a doctor–patient relationship. Medical research is continually updated, and study findings have their own scope and limitations. Every patient's condition, laboratory values, medications and treatment needs differ. Do not stop or adjust medication doses, change your diet or fluid intake, or alter dialysis or transplant treatment based on this article alone. For any medical questions, please consult your nephrologist or another qualified healthcare professional.

Article created: 2026-10-28 | Original study published: 2026-09-30 | Last checked: 2026-10-28 (source metadata checked with PubMed)