Status:
SUSPENDED
Anakinra vs Prednisone to Treat Gout Flare in Patients With Chronic Kidney Disease Stage 4/5 or Renal Transplantation
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Gout
Chronic Kidney Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Gout is secondary to urate crystal deposition after chronic elevation of serum urate level. Urate crystal deposition is responsible for acute and recurrent inflammatory flares which can be treated wit...
Detailed Description
The study will include 234 gouty patients with CKD 4/5 or renal transplantation with gout flare This study will include the following visits: \- Selection/inclusion visit (V0): Patient with gout fl...
Eligibility Criteria
Inclusion
- Adults aged over 18 years old
- Gout confirmed by identification of urate crystals by joint fluid or tophus analysis or by ultrasound of the affected joint and/or
- Gout according to Nijmegen criteria (presence of a score ≥ 8/13) depending on the following items:
- Man (2 pts) Previous crisis (2 pts) Involvement of first metatarsophalangeal joint (MTP1) (2.5 pts) Maximum pain within 24 hours (0.5pt) Redness (1 pt) HTA or cardiovascular disease (1.5 pts) SUL \> 360 μmol/l during the crisis (3.5 pts)
- Chronic kidney disease stage 3b/4/5 or renal transplantation
- Flare ≤ 5 days
- Pain assessed by visual analogical scale \> 4/10
Exclusion
- Participating in another trial including the administration of a drug
- Active infection
- History of anakinra or prednisone allergy
- Contra-indication of anakinra or prednisone
- Neutrophil count \< 1000/mm3 (not due to ethnic cause)
- Difficulty understanding French
- Illiteracy
- Pregnant women or breastfeeding mothers (see PHC article L.1121-5)
- Persons deprived of liberty by judicial or administrative decision, persons receiving psychiatric care under Sections L. 3212-1 and L. 3213-1 and persons admitted to a health or social institution for purposes other than research (see CSP Article L.1121-6)
- Major persons subject to a measure of legal protection or unseeding to express consent (see PHC Article L.1121-8)
- Persons not affiliated to a social security plan or beneficiaries of such a plan (see PHC Article L.1121-8-1)
Key Trial Info
Start Date :
June 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 12 2026
Estimated Enrollment :
204 Patients enrolled
Trial Details
Trial ID
NCT04844814
Start Date
June 2 2022
End Date
March 12 2026
Last Update
April 2 2025
Active Locations (1)
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1
Rhumathology department
Paris, Île-de-France Region, France, 75010