ASGARD

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The ASGARD study compares steroids, the safest treatment currently available for acute gout attacks in patients with chronic kidney disease, with a new treatment called Anakinra.

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. the current UK standard treatment, Depo-medrone for acute gout attacks in patients with moderate chronic kidney disease.

Short title: 

ASGARD

Study objectives/aims:

The primary objective of the study is to determine the feasibility of running a phase III double-blind, double-dummy randomised controlled trial comparing Depo-Medrone vs. Anakinra for the treatment of acute gout attacks in patients with chronic kidney disease. As part of the study secondary objectives will also be assessed.

Type of trial:

Double-blind, double-dummy, multi-centre randomised controlled trial (feasibility).

Sample size:

32 patients across six centres.

Participating sites:

 Centre   Address
 Southend University NHS Foundation Trust  Prittlewell Chase, Westcliff-on-Sea, Southend, Essex, SS0 0RY
 Barts and the London NHS Trust  The Royal London Hospital, Whitechapel Road, London, E1 1BB
 The Princess Alexandra Hospital NHS Trust  Hamstel Road, Harlow, Essex, CM20 1QX
 Basildon and Thurrock University Hospital NHS Foundation Trust  Nethermayne, Basildon, Essex, SS16 5NL
 West Suffolk Hospital NHS Trust  Hardwick Lane, Bury St Edmunds, Suffolk, IP33 2QZ
 East and North Hertfordshire NHS Trust (Lister)
 Coreys Mill Lane, Stevenage, Hertfordshire, SG1 4AB


Study duration:

Three months set up, 15 months recruitment, three months data analysis (for trial participants – eight weeks).

Timeframe:

Trial set up: 01/05/2016 to 01/08/2016.

Planned recruitment start date: August 2016.

Trial details:

The feasibility study is a multi-centre, randomised, double-blind, double-dummy controlled trial. The overarching aim is to undertake a definitive trial to show which of the currently available treatment options for acute gout in patients with kidney disease is the most efficacious, cost-effective and safe for the treatment of acute gout attacks in patients with kidney disease.

There will be 32 patients with moderate kidney disease and acute gout enrolled into this study. Moderate chronic kidney disease patients presenting to secondary care with an acute hot swollen joint due to gout will be approached and recruited into this study. Patients will be randomised into one of two arms of treatment, Group A (Experimental arm) will receive a five-day course of Anakinra with a one-day course placebo of Depo-Medrone (Lipofundin), Group B (Comparator arm) will receive a one-day course of Depo-Medrone with a five-day course placebo of Anakinra.

Chief Investigator:

Gowrie Balasubramaniam

Trial Sponsor:

Southend University NHS Foundation Trust, Prittlewell Chase, Westcliff-on-Sea, Southend, Essex, SS0 0RY.

Funding:

NIHR RfPB

For further information please use the links below

For Trial Participants

For Investigators