RESUMEN
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. TRIAL REGISTRATION NUMBER: EudraCT No. 2015-001787-19, NCT/Clinicalstrials.gov No. NCT02578394, pre-results, WHO Universal Trials Reference No. U1111-1175-1977. NIHR Grant PB-PG-0614-34090.
Asunto(s)
Gota/tratamiento farmacológico , Proteína Antagonista del Receptor de Interleucina 1/administración & dosificación , Metilprednisolona/administración & dosificación , Insuficiencia Renal Crónica/complicaciones , Análisis Costo-Beneficio , Método Doble Ciego , Estudios de Factibilidad , Humanos , Inyecciones Intramusculares , Calidad de Vida , Receptores de Interleucina-1/antagonistas & inhibidores , Proyectos de Investigación , Reino UnidoRESUMEN
In countries across Europe governments are facing aging populations, increasing dependency ratios and the need to increase the labor market participation of older men and women. In the past, the lifestyle of those in there 50s was characterized by a high degree of permanence and stability. Now, with rapid economic and social restructuring, a broadly homogeneous 50s age group has become fragmented into a number of diverse groupings driven by different types of employment, family forms and other biographical experiences.