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.
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).
Show all 22Show fewer
- 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.
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.
- Conditions
- Gout, Chronic Kidney Diseases
- 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 group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Anakinra 100mg and Placebo Depo-Medrone Receives: Drug: Anakinra 100mg and Placebo Depo-Medrone |
| Group B | Active comparator | Depo-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.
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)
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
Physician / Investigator assessment of joint tenderness and swelling
4-point Likert scale score
Measured: Day 1, Day 2, Day 4 and Day 7
Participant assessment of activity limitation
Lower Extremity Functional Scale score
Measured: Day 1, Day 2, Day 5, Day 7
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
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
Participant assessment of quality of life
SF-36 score
Measured: Day 1, Day 7 and 8
Healthcare resource use
Highly modified client service use inventory score
Measured: 8 weeks
CRP
Changes in CRP
Measured: Day 1, Day 4 and Day 7
White Cell Count
Changes in white cell count. Number of participants who develop neutropenia
Measured: Day 1, Day 4 and Day 7
eGFR
Changes in eGFR
Measured: Day 1, Day 4 and Day 7
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.
- First posted19 Oct 2015 (estimated)
- Study startApr 2016
- Primary completion26 Jan 2022
- Study completion26 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for GoutStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Mid and South Essex NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Anglia Ruskin University, University of East Anglia, University of Essex, National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Gowrie Balasubramaniam, MB ChB, Principal investigator, Mid and South Essex NHS Foundation Trust
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 42816092Balasubramaniam 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
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02578394
- Acronym / sponsor ID
- ASGARD / P0850
- Conditions
- Gout, Chronic Kidney Diseases
- Keywords
- Gout, Kidney, Depo-Medrone, Anakinra
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Mid and South Essex NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Anglia Ruskin University, University of East Anglia, University of Essex, National Institute for Health Research, United Kingdom
- Study start
- Apr 2016 (actual)
- Primary completion
- 26 Jan 2022 (actual)
- Study completion
- 26 Jan 2022 (actual)
- First posted
- 19 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: Anakinra 100mg and Placebo Depo-MedroneAnakinra 100mg and Placebo Depo-Medrone |
| Group B | Active comparator | Drug: Depo-Medrone 120mg and Placebo (Anakinra)Depo-Medrone 120mg and Placebo (Anakinra) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anakinra 100mg and Placebo Depo-MedroneAlso: KineretAnakinra 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 | Group A |
| Depo-Medrone 120mg and Placebo (Anakinra)Also: Methylprednisolone AcetateDepo-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. | Drug | Group B |
Primary outcome
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
VAS (0-100mm) and 5-point Likert scale.
11 secondary outcomes
Participant reported outcome measure of treatment response
Time frame: Day 2, Day 3, Day 4, Day 5, Day 6 and Day 7
Physician / Investigator assessment of joint tenderness and swelling
Time frame: Day 1, Day 2, Day 4 and Day 7
Participant assessment of activity limitation
Time frame: Day 1, Day 2, Day 5, Day 7
Participant assessment of activity limitation and quality of life
Time frame: Day 1, Day 2, Day 4, Day 7 and 8 weeks
Participant assessment of activity limitation and quality of life using HAQ-DI
Time frame: Day 1, Day 7 and 8
Participant assessment of quality of life
Time frame: Day 1, Day 7 and 8
Healthcare resource use
Time frame: 8 weeks
CRP
Time frame: Day 1, Day 4 and Day 7
White Cell Count
Time frame: Day 1, Day 4 and Day 7
eGFR
Time frame: Day 1, Day 4 and Day 7
Safety reporting
Time frame: Day 1 to 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- Derived from this study: PubMed 42816092Balasubramaniam 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.
- Derived from this study: PubMed 28877949Balasubramaniam 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gowrie Balasubramaniam, MB ChB principal investigator
Mid and South Essex NHS Foundation Trust
1 site in 1 country: see every site and its status.
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.