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Anakinra vs. Steroids for the Treatment of Gout Attacks in Patients With Renal Disease (ASGARD): A Feasibility Study

NCT02578394 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2022-04-06

No results posted yet for this study

Summary

The aim of this study is to determine the feasibility of running a phase III double-blind, double-dummy randomised controlled trial comparing Depo-Medrone 120mg intramuscular injection vs. Anakinra 100mg subcutaneous injection for 5 days for the treatment of acute gout attacks in patients with chronic kidney disease as defined by a eGFR \< 60mls/min/1.73m2 and ≥ 30mls/min/1.73m2.

Conditions

  • Gout
  • Chronic Kidney Diseases

Interventions

DRUG

Anakinra 100mg and Placebo Depo-Medrone

Anakinra 100mg injection S/C Day 1 to Day 5 and Placebo Depo-Medrone (Lipofundin 3mL) I/M Day 1. Anakinra is an interleukin-1 receptor antagonist. Placebo for Depo-Medrone placebo is Lipofundin MCT/LCT 10%.

DRUG

Depo-Medrone 120mg and Placebo (Anakinra)

Depo-Medrone 120mg in 3mL. Placebo for Anakinra supplied from manufacturer. 120mg Depo-Medrone I/M Day 1 and Placebo Anakinra 100mg injection S/C Day 1 to Day 5.

Sponsors & Collaborators

  • Anglia Ruskin University

    collaborator OTHER

  • University of East Anglia

    collaborator OTHER

  • University of Essex

    collaborator OTHER

  • National Institute for Health Research, United Kingdom

    collaborator OTHER_GOV

  • Mid and South Essex NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Gowrie Balasubramaniam, MB ChB · Mid and South Essex NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2022-01-26
Completion
2022-01-26

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02578394 on ClinicalTrials.gov