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ANA4CKD - Randomized multicenter double-blind controlled trial comparing anakinra to prednisone for gout flare in patients with chronic kidney disease stage 4-5 or kidney transplantation

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-514347-28-00
Acronym
APHP180560
Enrollment
234
Registered
2024-10-21
Start date
2022-06-02
Completion date
2025-02-12
Last updated
2024-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Men and women over 18 years of age with renal failure renal failure stages 3b/4/5, renal transplantation or dialysis and an untreated gout attack

Brief summary

The main evaluation criterion will be the change in pain between the day of inclusion and 3 days after initiation of treatment (D3) or the day of discharge from hospitalization if this occurs before D3.

Detailed description

Efficacy of anakinra: To compare changes in pain from baseline to D5, Efficacy of anakinra: To compare speed of resolution of attacks(>80% improvement or pain less than 20 mm), Efficacy of anakinra: To compare treatment response time (more than 50% improvement), Efficacy of anakinra: To compare duration of treatment, Efficacy of anakinra: To compare number of responders (improvement at D3), Efficacy of anakinra: To compare the number of relapses during the study month of the study, • Efficacy of anakinra: To compare consumption of care during the month of the study: length of hospital stay, use of analgesics, length of time off work, Tolerance of anakinra: To compare injection-site reactions, Tolerance of anakinra: To compare decreases in neutrophils or platelets, Tolerance of Anakinra: To compare severe infections, Tolerance of anakinra: To compare decompensation of comorbidities: HTA, diabetes, dyslipidemia, obesity, CKD, •- Tolerance of anakinra: To compare cardiovascular events: myocardial infarction myocardial infarction, arrhythmia, heart failure relapse heart failure, stroke

Interventions

Sponsors

Assistance Publique Hopitaux De Paris
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The main evaluation criterion will be the change in pain between the day of inclusion and 3 days after initiation of treatment (D3) or the day of discharge from hospitalization if this occurs before D3.

Secondary

MeasureTime frame
Efficacy of anakinra: To compare changes in pain from baseline to D5, Efficacy of anakinra: To compare speed of resolution of attacks(>80% improvement or pain less than 20 mm), Efficacy of anakinra: To compare treatment response time (more than 50% improvement), Efficacy of anakinra: To compare duration of treatment, Efficacy of anakinra: To compare number of responders (improvement at D3), Efficacy of anakinra: To compare the number of relapses during the study month of the study, • Efficacy of anakinra: To compare consumption of care during the month of the study: length of hospital stay, use of analgesics, length of time off work, Tolerance of anakinra: To compare injection-site reactions, Tolerance of anakinra: To compare decreases in neutrophils or platelets, Tolerance of Anakinra: To compare severe infections, Tolerance of anakinra: To compare decompensation of comorbidities: HTA, diabetes, dyslipidemia, obesity, CKD, •- Tolerance of anakinra: To compare cardiovascular events: m

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026