Anakinra vs. Steroids for the Treatment of Gout Attacks in Patients With Renal Disease (ASGARD): A Feasibility Study
ASGARD
A Feasibility Study to Undertake a Definitive Randomised Multi-centre, Double-blind, Double-dummy Controlled Study of a Novel Agent Anakinra vs. Depo-Medrone for Acute Gout Attacks in Patients With Moderate Chronic Kidney Disease
3 other identifiers
interventional
21
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Apr 2016
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 2, 2015
CompletedFirst Posted
Study publicly available on registry
October 19, 2015
CompletedStudy Start
First participant enrolled
April 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 26, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 26, 2022
CompletedApril 6, 2022
April 1, 2022
5.8 years
October 2, 2015
April 5, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Resolution of pain: time to 50% reduction and complete resolution of pain in self-assessed pain intensity in the joint most affected.
VAS (0-100mm) and 5-point Likert scale.
Baseline (Day 1) to Day 7
Secondary Outcomes (11)
Participant reported outcome measure of treatment response
Day 2, Day 3, Day 4, Day 5, Day 6 and Day 7
Physician / Investigator assessment of joint tenderness and swelling
Day 1, Day 2, Day 4 and Day 7
Participant assessment of activity limitation
Day 1, Day 2, Day 5, Day 7
Participant assessment of activity limitation and quality of life
Day 1, Day 2, Day 4, Day 7 and 8 weeks
Participant assessment of activity limitation and quality of life using HAQ-DI
Day 1, Day 7 and 8
- +6 more secondary outcomes
Study Arms (2)
Group A
ACTIVE COMPARATORAnakinra 100mg and Placebo Depo-Medrone
Group B
ACTIVE COMPARATORDepo-Medrone 120mg and Placebo (Anakinra)
Interventions
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%.
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.
Eligibility Criteria
You may qualify if:
- Subjects capable of giving informed consent.
- Male or non-pregnant, non-nursing female
- ≥ 18 years of age
- eGFR \< 60mls/min/1.73m2 and ≥ 30mls/min/1.73m2 as calculated using serum creatinine and modified MDRD formula as per renal association guidelines.
- Diagnosis of gout arthritis as defined by the American College of Rheumatology 1977 preliminary criteria (this criteria is currently endorsed by NICE guidelines).
- Gout flare less ≤ 36 hours
- Baseline pain intensity \> or equal to 50mm on the 0-100 mm VAS. In the case of multiple joints (≤ 3), the most affected joint will be assessed.
You may not qualify if:
- Treatment with NSAIDS in last 48 hours, systemic steroids in last 4 weeks or colchicine within 7 days.
- Polyarticular gout, i.e. affecting four or more 4 joints
- Rheumatoid arthritis, evidence/suspicion of infectious/septic arthritis, or other acute inflammatory arthritis such as systemic lupus erythematosus, mixed connective tissue disease, scleroderma, polymyositis, or significant systemic involvement secondary to rheumatoid arthritis.
- Con-current immunosuppression/immunomodulatory treatment (Calcineurin inhibitor, anti-proliferative or biologic) therapy for other reason i.e. organ transplant.
- Prior history or current inflammatory joint disease other than gout (e.g. rheumatoid arthritis (RA), reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme disease). Concurrent medication for RA like methotrexate and anti-TNF treatment has been associated with increased risk of neutropenia and infection.
- Current active malignancy (with the exception of basal cell or squamous cell carcinoma of the skin, cervical intraepithelial neoplasia and non-metastatic/advanced prostate cancer).
- Any patients with contra-indication to intramuscular injection such as coagulopathy or thrombocytopenia (Platelet count\<100 x 109/L (100,000/mm3)).
- Abnormal liver function tests: Total bilirubin\>upper limit of normal, Alanine aminotransferase (ALT) or Aspartate Aminotransferase (AST) \>2 times upper limit of normal.
- Haemoglobin \<85g/L (8.5 g/dL)
- White blood cell (WBC) count\<1.5 x 109/L (1000/mm3), absolute neutrophil count\<1.5 x 109/L (1000/mm3)
- Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary (including obstructive pulmonary disease), hepatic, endocrine (including uncontrolled diabetes) or gastrointestinal disease.
- Known positive hepatitis B virus surface antigen (HBsAg), hepatitis C (HCV) antibody or HIV.
- Females of child bearing potential who are not willing to use highly effective birth control methods from the time of consent to one week after treatment discontinuation. Highly effective method of contraception (hormonal or barrier method of birth control; abstinence) consist of:
- Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation; oral, intravaginal, transdermal.
- Progestogen-only hormonal contraception associated with inhibition of ovulation; oral, injectable, implantable.
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mid and South Essex NHS Foundation Trustlead
- Anglia Ruskin Universitycollaborator
- University of East Angliacollaborator
- University of Essexcollaborator
- National Institute for Health Research, United Kingdomcollaborator
Study Sites (1)
Southend Hospital
Southend-on-Sea, Essex, SS0 0RY, United Kingdom
Related Publications (1)
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, Dasgupta B. 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. 2017 Sep 5;7(9):e017121. doi: 10.1136/bmjopen-2017-017121.
PMID: 28877949DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gowrie Balasubramaniam, MB ChB
Mid and South Essex NHS Foundation Trust
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 2, 2015
First Posted
October 19, 2015
Study Start
April 1, 2016
Primary Completion
January 26, 2022
Study Completion
January 26, 2022
Last Updated
April 6, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share