Randomized double-blind controlled trial comparing anakinra to prednisone for gout flare in patients with chronic kidney disease or kidney transplantatio

Phase 1

• Conditions: Men and women of more than 18 years old with a stage 4 or 5 kidney insufficiency or or a kidney insufficiency and an untreated gout attack; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2019-002570-31-FR
• Lead Sponsor: Assitance Publique - Hôpitaux de Paris

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-27
• Last Update Posted: 8 January 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 234

Inclusion Criteria

- adult of more than 18 years old
- Gout attack confirmed by evidence urat cristal in joint liquid analysis or of the tophus or ultrasound examination of the joint or
- Gout attack according to NIjmegen citeria (score > 8/13) for the following items :
•Maen (2 pts)
•Previous attack (2 pts)
•Fisrt ray of metatarsophangeal (2.5 pts)
•Attack maximum in less than 24 hours (0.5pt)
•Redness (1 pt)
•AHT or cardiovascular disease (1.5 pts)
•URICEMIA > 360 µmol/l during crisis (3.5 pts)
- Crisis = 5 jours
- VEA = 50/100
- Chronic Kidney disease stage 4 or 5 or kidney transplanted patient
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 44

Exclusion Criteria

--Participation to another trial uncluding the a use of a medicine
-Active infection
-Known allergty to anakinra
-Neutropenia < 1000 /mm3
-KCD= 3
-Difficulties in understanding French
-Analphabetism
-Pregnenant women, parturient or breastfeeding women allaitent (Cf. CSP article L.1121-5)
-Persons deprived of liberty by court or administrative decision Personnes, person subject of psychiatric healthcare (L. 3212-1 and L. 3213-1) and persons admitted in a social or healthcare facility for other purposes than research (Cf. CSP L.1121-6)
-Adults subject of legal protection or unable to give teheir consent (Cf. CSP article L.1121-8)
-Persons unafiliated to a social secutrity scheme or beneficiary of such a scheme (Cf. CSP article L.1121-8-1)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified