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Clinical Trial Details

Trial ID: L0180
Source ID: NCT02578394
Associated Drug: Anakinra 100mg And Placebo Depo-Medrone
Title: Anakinra vs. Steroids for the Treatment of Gout Attacks in Patients With Renal Disease (ASGARD): A Feasibility Study
Acronym: ASGARD
Status: COMPLETED
Study Results: NO
Results:
Conditions: Gout|Chronic Kidney Diseases
Interventions: DRUG: Anakinra 100mg and Placebo Depo-Medrone|DRUG: Depo-Medrone 120mg and Placebo (Anakinra)
Outcome Measures: Primary: 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: Participant reported outcome measure of treatment response, 5-point Likert scale score, 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, Day 1, Day 2, Day 4 and Day 7|Participant assessment of activity limitation, Lower Extremity Functional Scale score, 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, 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, Day 1, Day 7 and 8|Participant assessment of quality of life, SF-36 score, Day 1, Day 7 and 8|Healthcare resource use, Highly modified client service use inventory score, 8 weeks|CRP, Changes in CRP, Day 1, Day 4 and Day 7|White Cell Count, Changes in white cell count. Number of participants who develop neutropenia, Day 1, Day 4 and Day 7|eGFR, Changes in eGFR, Day 1, Day 4 and Day 7|Safety reporting, Number of participants with treatment-related adverse events as assessed by CTCAE v4.0, Day 1 to 8 weeks
Sponsor/Collaborators: Sponsor: Mid and South Essex NHS Foundation Trust | Collaborators: Anglia Ruskin University|University of East Anglia|University of Essex|National Institute for Health Research, United Kingdom
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2|PHASE3
Enrollment: 21
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2016-04
Completion Date: 2022-01-26
Results First Posted:
Last Update Posted: 2022-04-06
Locations: Southend Hospital, Southend on Sea, Essex, SS0 0RY, United Kingdom
URL: https://clinicaltrials.gov/show/NCT02578394