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GoutPhase 2/3ASGARDNCT02578394

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

A Phase 2/3 study of Gout and Chronic Kidney Diseases, run by Mid and South Essex NHS Foundation Trust at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Gout, Chronic Kidney Diseases
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
21 participants
Where
1 siteUnited Kingdom
Study dates
Apr 2016to 26 Jan 2022
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).
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  • 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.
  • Intrauterine device (IUD) or intrauterine hormone-releasing system (IUS)
  • Bilateral tubal occlusion or vasectomised partner
  • Sexual abstinence
  • Females of childbearing potential must have a negative pregnancy test (highly sensitive urine or serum pregnancy test after a confirmed menstrual period) within 7 days prior to treatment initiation. Subjects are considered not of child bearing potential if they are surgically sterile (i.e. they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal.
  • Females must not be breastfeeding.
  • Patients who have had treatment as part of this trial cannot have repeat treatment for another flare as part of the trial.
  • Patient with allergies to excipients of IMPs: citric acid, anhydrous, sodium chloride, disodium edetate dehydrate, polysorbate 80, sodium hydroxide. Hypersensitivity to E. Coli derived proteins, egg proteins and soy proteins. Patients with a latex allergy are also not eligible as the inner needle cover of the pre-filled syringe contains dry natural rubber (a derivative of latex).

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • Southend Hospital

    Southend-on-Sea, Essex, SS0 0RY

Other trials in United Kingdom

About this study

Official title: 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

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.

Read the detailed description

Gout is a common condition that affects 1 in 40 people in the UK. It causes painful "attacks" of joint swelling, redness and tenderness, mostly affecting the foot, ankle, knee, hand and wrist. It is common in people with kidney disease, who also tend to be older people with other medical conditions such as high blood pressure, heart disease and diabetes. The investigators do not know the safest and best way to treat gout attacks in this increasing cohort of people. A lot of people are given treatment that can worsen their kidney disease, along with their other medical conditions.

The investigators want to compare the safest treatment currently available, steroids, with a new treatment called Anakinra. This treatment stops the action of a chemical called interleukin-1 which has been discovered to play an important role in gout attacks. This treatment has already been used to treat gout attacks in a handful of patients with kidney disease. The investigators feel it may be a better alternative to steroid treatment which can sometime worsen diabetes, heart disease and blood pressure. Participants will predominantly be followed-up for one week and a final 8 week follow-up, and be recruited from hospitals in the East of England.

A definitive scientific study comparing these two treatments would involve a big expensive study requiring large numbers of patients and large amounts of information to be collected. Before the investigators do a big study like this, the investigators want to perform a small study using a smaller number of patients (32 patients) over a period of 22 months in total. It will then give us information to plan a larger study to answer the question of which treatment may be better, safer and provides the most value for money for the NHS.

Being tested
Anakinra 100mg and Placebo Depo-Medrone, Depo-Medrone 120mg and Placebo (Anakinra)
Keywords
Gout, Kidney, Depo-Medrone, Anakinra
Medical subject headings
Gout, Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Anakinra 100mg and Placebo Depo-MedroneDrug

    Also called Kineret

    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 and Placebo (Anakinra)Drug

    Also called Methylprednisolone Acetate

    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.

Study groups in NCT02578394
Study groupRoleWhat they receive
Group AActive comparatorAnakinra 100mg and Placebo Depo-Medrone
Receives: Drug: Anakinra 100mg and Placebo Depo-Medrone
Group BActive comparatorDepo-Medrone 120mg and Placebo (Anakinra)
Receives: Drug: Depo-Medrone 120mg and Placebo (Anakinra)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline (Day 1) to Day 7

Secondary outcomes (11)
  1. Participant reported outcome measure of treatment response

    5-point Likert scale score

    Measured: Day 2, Day 3, Day 4, Day 5, Day 6 and Day 7

  2. Physician / Investigator assessment of joint tenderness and swelling

    4-point Likert scale score

    Measured: Day 1, Day 2, Day 4 and Day 7

  3. Participant assessment of activity limitation

    Lower Extremity Functional Scale score

    Measured: Day 1, Day 2, Day 5, Day 7

  4. Participant assessment of activity limitation and quality of life

    EQ-5D-5L health states will be used to calculate the index. Health profiles will be obtained and Quality Adjusted Life Years will be derived

    Measured: Day 1, Day 2, Day 4, Day 7 and 8 weeks

  5. Participant assessment of activity limitation and quality of life using HAQ-DI

    Scores calculated from single scales and each dimension

    Measured: Day 1, Day 7 and 8

  6. Participant assessment of quality of life

    SF-36 score

    Measured: Day 1, Day 7 and 8

  7. Healthcare resource use

    Highly modified client service use inventory score

    Measured: 8 weeks

  8. CRP

    Changes in CRP

    Measured: Day 1, Day 4 and Day 7

  9. White Cell Count

    Changes in white cell count. Number of participants who develop neutropenia

    Measured: Day 1, Day 4 and Day 7

  10. eGFR

    Changes in eGFR

    Measured: Day 1, Day 4 and Day 7

  11. Safety reporting

    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Measured: Day 1 to 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2015 (estimated)
  2. Study startApr 2016
  3. Primary completion26 Jan 2022
  4. Study completion26 Jan 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02578394
Sponsor's protocol ID
P0850
Other IDs
2015-001787-19, PB-PG-0614-34090, 2015
Acronym
ASGARD
Status last verified
Apr 2022
First submitted
2 Oct 2015
Last updated
6 Apr 2022
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Balasubramaniam G, Almond M, Harnett P, Turner D, Scales J, Zhang J, Moore C, Hayden K, Roddy E, Mallen C, Stack J, Bhagat S, Ng N, Rutherford A, Dasgupta B. Anakinra versus intramuscular methylprednisolone acetate for gout flares in people with chronic kidney disease (ASGARD): a UK randomised multicentre, double-blind, double-dummy controlled feasibility study with economic, qualitative and safety assessment. BMJ Open. 2026 Sep 30;16(9):e114454. doi: 10.1136/bmjopen-2025-114454.

    PubMed 42816092
  • 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.

    PubMed 28877949

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study of Gout and Chronic Kidney Diseases, run by Mid and South Essex NHS Foundation Trust at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Resolution of pain: time to 50% reduction and complete resolution of pain in self-assessed pain intensity in the joint most affected. (time frame: Baseline (Day 1) to Day 7). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02578394, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2022.

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