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

Balasubramaniam, Gowrie and Parker, Trisha and Turner, David and Parker, Mike and Scales, Jonathan and Harnett, Patrick and Harrison, Michael and Ahmed, Khalid and Bhagat, Sweta and Marianayagam, Thiraupathy and Pitzalis, Costantino and Mallen, Christian and Roddy, Edward and Almond, Mike and Dasgupta, Bhaskar (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. ISSN 2044-6055

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Official URL: https://doi.org/10.1136/bmjopen-2017-017121

Abstract

Introduction Acute gout occurs in people with chronic kidney disease, who are commonly older people with comorbidities such as hypertension, heart disease and diabetes. Potentially harmful treatments are administered to these vulnerable patients due to a lack of clear evidence. Newly available treatment that targets a key inflammatory pathway in acute gout attacks provides an opportunity to undertake the first-ever trial specifically looking treating people with kidney disease. This paper describes the protocol for a feasibility randomised controlled trial (RCT) comparing anakinra, a novel interleukin-1 antagonist versus steroids in people with chronic kidney disease (ASGARD). Methods and analysis ASGARD is a two-parallel group double-blind, double-dummy multicentre RCT comparing anakinra 100 mg, an interleukin-1 antagonist, subcutaneous for 5 days against intramuscular methylprednisolone 120 mg. The primary objective is to assess the feasibility of the trial design and procedures for a definitive RCT. The specific aims are: (1) test recruitment and retention rates and willingness to be randomised; (2) test eligibility criteria; (3) collect and analyse outcome data to inform sample and power calculations for a trial of efficacy; (4) collect economic data to inform a future economic evaluation estimating costs of treatment and (5) assess capacity of the project to scale up to a national multicentre trial. We will also gather qualitative insights from participants. It aims to recruit 32 patients with a 1:1 randomisation. Information from this feasibility study will help design a definitive trial and provide general information in designing acute gout studies. Ethics and dissemination The London-Central Ethics Committee approved the protocol. The results will be disseminated in peer-reviewed journals and at scientific conferences.

Item Type: Journal Article
Keywords: acute gout, anakinra, chronic kidney disease, feasibility, intramuscular methylprednisolone
Faculty: ARCHIVED Faculty of Medical Science (until September 2018)
Depositing User: Ian Walker
Date Deposited: 04 Dec 2017 11:21
Last Modified: 04 Dec 2017 11:23
URI: http://arro.anglia.ac.uk/id/eprint/702502

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