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Clinical Trial Details

Trial ID: L0669
Source ID: NCT04844814
Associated Drug: Anakinra 100mg/0.67ml Inj Syringe
Title: Anakinra vs Prednisone to Treat Gout Flare in Patients With Chronic Kidney Disease Stage 4/5 or Renal Transplantation
Acronym: Ana4CKD
Status: SUSPENDED
Study Results: NO
Results:
Conditions: Gout|Chronic Kidney Disease|Renal Transplantation
Interventions: DRUG: Anakinra 100Mg/0.67Ml Inj Syringe|DRUG: Prednisone|DRUG: Placebo of Prednisone|DRUG: Placebo of Anakinra
Outcome Measures: Primary: Pain difference between Day 3 and treatment initiation, Pain difference between day 3 and treatment initiation assessed by visual analogical scale (VAS) from 0 to 10 VAS = 0, no pain VAS =10, maximal pain, Day 3 | Secondary: Percentage of responders (improvement ≥ 50%) at day 5, Percentage of responders (improvement ≥ 50%) at day 5, Day 5|Percentage of flare resolution (improvement ≥ 80%) at day 5, Percentage of flare resolution (improvement ≥ 80%) at day 5, Day 5|Time to treatment response, Time to treatment response, Day 3 or Day 5|Time to flare resolution, Time to flare resolution, Day 3 or Day 5|Treatment duration, Treatment duration, Day3 or Day 5|Duration of hospitalization, Duration of hospitalization, Day 3 or Day 5|Healthcare consumption at month 1 : number of consultations and hospitalizations related to gout flare, Healthcare consumption at month 1 assessed by number of consultations and hospitalizations related to gout flare, Month 1|Healthcare consumption at month 1: total hospital stay, Healthcare consumption at month 1 assessed by total hospital stay, Month 1|Healthcare consumption at month 1, Healthcare consumption at month 1 assessed by number and cumulative duration of sick leave related to gout, Month 1|Side effects, Side effects, Month 1|Comorbidity decompensations at month 1 : DT2 decompensation, Comorbidity decompensations at month 1 assessed by DT2 decompensation measure, Month 1|Comorbidity decompensations at month 1: Blood pressure, Comorbidity decompensations at month 1 assessed by Blood pressure measure, Month 1|Comorbidity decompensations at month 1: Hypertension, Comorbidity decompensations at month 1 assessed by hypertension measure, Month 1|Comorbidity decompensations at month 1: Weight, Comorbidity decompensations at month 1 assessed by Weight measure, Month 1|Comorbidity decompensations at month 1: number of Cardiovascular events : coronary disease, heart attack, stroke, Comorbidity decompensations at month 1 assessed by number of Cardiovascular events : coronary disease, heart attack, stroke, Month 1|Comorbidity decompensations at month 1: Blood analysis of serum creatinine level, Comorbidity decompensations at month 1 assessed by serum creatinine level measure, Month 1|Comorbidity decompensations at month 1: Blood analysis of epidermal Growth Factor Receptor (eGFR), Comorbidity decompensations at month 1 assessed by eGFR measure, Month 1|Comorbidity decompensations at month 1: Blood analysis of C reactive protein (CRP), Comorbidity decompensations at month 1 assessed by CRP measure, Month 1|Comorbidity decompensations at month 1: Blood analysis of HbA1C, Comorbidity decompensations at month 1 assessed by HbA1C measure, Month 1|Comorbidity decompensations at month 1: Blood analysis of total cholesterol, Comorbidity decompensations at month 1 assessed by total cholesterol measure, Month 1|Comorbidity decompensations at month 1: Blood analysis of LDL cholesterol, Comorbidity decompensations at month 1 assessed by HDL cholesterol measure, Month 1|Comorbidity decompensations at month 1: Blood analysis of HDL cholesterol, Comorbidity decompensations at month 1 assessed by HDL cholesterol measure, Month 1|Comorbidity decompensations at month 1: Blood analysis of triglyceride, Comorbidity decompensations at month 1 assessed by triglyceride measure, Month 1|Comorbidity decompensations at month 1: Blood analysis of glycaemia, Comorbidity decompensations at month 1 assessed by glycaemia measure, Month 1|site injection reaction during day 0 to day 5: pain, site injection reaction during day 0 to day 5 assessed by pain (0-10 scale VAS) measure, Dat 3 or day 5|site injection reaction during day 0 to day 5: inflammatory reaction, site injection reaction during day 0 to day 5 assessed by CRP level measure, Dat 3 or day 5|site injection reaction during day 0 to day 5: swelling (yes/no), site injection reaction during day 0 to day 5 assessed by swelling (yes/no), Dat 3 or day 5|site injection reaction during day 0 to day 5: itching (yes/no), site injection reaction during day 0 to day 5 assessed by itching (yes/no), Dat 3 or day 5|site injection reaction during day 0 to day 5: redness (yes/no), site injection reaction during day 0 to day 5 assessed by redness (yes/no), Dat 3 or day 5
Sponsor/Collaborators: Sponsor: Assistance Publique - Hôpitaux de Paris
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 204
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2022-06-02
Completion Date: 2026-03-12
Results First Posted:
Last Update Posted: 2025-04-02
Locations: Rhumathology department, Paris, Ile-De-France, 75010, France
URL: https://clinicaltrials.gov/show/NCT04844814