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 - ANA4CKD

Assitance Publique - Hôpitaux de Paris0 个研究点目标入组 234 人开始时间: 2020年11月27日最近更新: 2024年1月8日

试验速览

暂无简介。

•- 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

•--Participation to another trial uncluding the a use of a medicine
•-Active infection
•-Known allergty to anakinra
•-Neutropenia < 1000 /mm3
•-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)

发起方

Assitance Publique - Hôpitaux de Paris