Anakinra vs. Steroids for the Treatment of Gout Attacks in Patients With Renal Disease (ASGARD): A Feasibility Study (ASGARD)
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|ClinicalTrials.gov Identifier: NCT02578394|
Recruitment Status : Unknown
Verified April 2016 by Southend University Hospital Foundation NHS Trust.
Recruitment status was: Recruiting
First Posted : October 19, 2015
Last Update Posted : April 11, 2016
|Condition or disease||Intervention/treatment||Phase|
|Gout Chronic Kidney Diseases||Drug: Anakinra 100mg and Placebo Depo-Medrone Drug: Depo-Medrone 120mg and Placebo (Anakinra)||Phase 2 Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||April 2016|
|Estimated Primary Completion Date :||June 2017|
|Estimated Study Completion Date :||August 2017|
Active Comparator: Group A
Anakinra 100mg and Placebo Depo-Medrone
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%.
Other Name: Kineret
Active Comparator: Group B
Depo-Medrone 120mg and Placebo (Anakinra)
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.
Other Name: Methylprednisolone Acetate
- 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.
- Participant reported outcome measure of treatment response [ Time Frame: Day 2, Day 3, Day 4, Day 5, Day 6 and Day 7 ]5-point Likert scale score
- Physician / Investigator assessment of joint tenderness and swelling [ Time Frame: Day 1, Day 2, Day 4 and Day 7 ]4-point Likert scale score
- Participant assessment of activity limitation [ Time Frame: Day 1, Day 2, Day 5, Day 7 ]Lower Extremity Functional Scale score
- Participant assessment of activity limitation and quality of life [ Time Frame: Day 1, Day 2, Day 4, Day 7 and 8 weeks ]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
- Participant assessment of activity limitation and quality of life using HAQ-DI [ Time Frame: Day 1, Day 7 and 8 ]Scores calculated from single scales and each dimension
- Participant assessment of quality of life [ Time Frame: Day 1, Day 7 and 8 ]SF-36 score
- Healthcare resource use [ Time Frame: 8 weeks ]Highly modified client service use inventory score
- CRP [ Time Frame: Day 1, Day 4 and Day 7 ]Changes in CRP
- White Cell Count [ Time Frame: Day 1, Day 4 and Day 7 ]Changes in white cell count. Number of participants who develop neutropenia
- eGFR [ Time Frame: Day 1, Day 4 and Day 7 ]Changes in eGFR
- Safety reporting [ Time Frame: Day 1 to 8 weeks ]Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02578394
|Contact: Gowrie Balasubramaniam, MB ChB||01702 firstname.lastname@example.org|
|Contact: Bhaskar Dasgupta, MB BS||01702 email@example.com|
|Southend University Hospital NHS Foundation Trust||Recruiting|
|Southend on Sea, Essex, United Kingdom, SS0 0RY|
|Contact: Gowrie Balasubramaniam 01702435555 ext 8430 G.Balasubramaniam@southend.nhs.uk|
|Contact: Craig Mackerness 01702 385089 firstname.lastname@example.org|
|Principal Investigator:||Gowrie Balasubramaniam, MB ChB||Southend University Hospital|