ASGARD

Full title: A study to determine the feasibility of undertaking a definitive randomised, multi-centre, double-blind, double-dummy, controlled study of a novel agent Anakinra, an IL-1 receptor antagonist vs. intramuscular methylprednisolone (Depo-Medrone) for acute gout attacks in patients with chronic kidney disease.

ASGARD is a feasibility study of a randomised controlled trial comparing steroids, the safest treatment currently available for acute gout attacks in patients with chronic kidney disease, with a newer treatment called Anakinra.

An older man self-administering an injection into his arm on his sofa at home

Gout is common in people with chronic kidney disease (CKD) but there is insufficient evidence to know the safest and best way to treat an attack of gout in a person with CKD.

This trial compares a UK standard treatment (Depo-Medrone) with a more novel agent, called Anakinra. Anakinra stops the action of a chemical called interleukin-1 (IL-1), which plays an important role in acute gout attacks.

This study is designed to determine the feasibility of undertaking a definitive randomised controlled study of Anakinra vs. Depo-Medrone for acute gout attacks in patients with moderate to severe chronic kidney disease. A larger study may then go on show which treatment may be most efficacious, cost-effective, and safe.

Trial setting, design, and methods

This is a multi-site trial conducted at Southend Hospital (Mid and South Essex NHS Foundation Trust (MSEFT)), King’s College Hospital NHS Foundation Trust, Guy’s and St Thomas’ NHS Foundation Trust, and West Suffolk NHS Foundation Trust. It is a feasibility trial and is designed as a randomised, multi-centre, double-blind, double-dummy, controlled study.

Twenty-one patients with moderate to severe kidney disease and acute gout were recruited. Participants were randomised to an experimental arm (five-day course of Anakinra with a one-day course placebo of Depo-Medrone) or comparator arm (one-day course of Depo-Medrone with a five-day course placebo of Anakinra).

Trial objectives

The primary objective is to assess feasibility of a definitive randomised controlled trial. As part of the study, secondary objectives will also be assessed.

Outputs

Balasubramaniam, G., Almond, M., Harnett, P., Zhang, J., Turner, D., Scales, J., Moore, C., Hayden, K., Roddy, E., Mallen, C., Ng, N., Bhagat, S., Rutherford, A. and Dasgupta, B. (2023) 'POSO508 A randomised controlled trial comparing anakinra versus steroids for the treatment of gout attacks in people with renal disease (ASGARD): A feasibility study', Annals of the Rheumatic Diseases, 82, pp. 516. Available at: https://doi.org/10.1136/annrheumdis-2023-eular.716

Balasubramaniam, G., Parker, T., Turner, D., Parker, M., Scales, J., Harnett, P., Harrison, M., Ahmed, K., Bhagat, S., Marianayagam, T., Pitzalis, C., Mallen, C., Roddy, E., Almond, M. and Dasgupta, B. (2017) 'Feasibility randomised multicentre, double-blind, double-dummy controlled trial of anakinra, an interleukin-1 receptor antagonist versus intramuscular methylprednisolone for acute gout attacks in patients with chronic kidney disease (ASGARD): protocol study', BMJ Open, 7(9), e017121. Available at: https://doi.org/10.1136/bmjopen-2017-017121



Chief Investigator: Dr Gowrie Balasubramaniam (MSEFT)
ARCTU involvement: Trial management; database; randomisation service; statistical service
Trial sponsor and funding: MSEFT (sponsor); NIHR (funder)
Project reference numbers: EudraCT: 2015-001787-19; ClincialTrials.gov: NCT02578394