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
Conditions
Interventions
Trade Name: Kineret
Product Name: kineret
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ANAKINRA
CAS Number: 143090-92-0
Concentration unit: mg/ml milligram(s)
Sponsors
Assitance Publique - Hôpitaux de Paris
Eligibility
Sex/Gender
All
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate superiority of anakinra over prednisone in the trreatment of gout attack in patient suffering from stage 4 or 5 chronic kidney disease and kideny transplantation;Secondary Objective: 1.Anakinra efficacy •To compare pain variation from inclusion to d5 •To compare speed of attack resolution (improvment of more than 80% or pain below 20mm) •To compare time to response to treatment (improvement of more than 50%) •To compare treatment duration •To compare number of responding patients (improvement at d3) •To compare number of relapse during the month of participation •To compare healthcare consumption during the mont of study participation: hospitalisatioon duration, antalgic consumption, sick leave duration, •To compare quality of life and handicap 2.Anakinra tolerance •To compare reaction at the injection site •To compare severe infections •To compare decrease of Neutrophile or platelets •To compare comorbidity decompensation : AHT, diabetis, dilipidemia, Chronic kideny disease •To compare cardiovascular events: myocard infarction, arythma, cardiac insuficiency burst, brain stroke ;Primary end point(s): Pain variation between days of inclusion and D3 after beginning of treatment;Timepoint(s) of evaluation of this end point: LSLV | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Anakinra efficacy o Dayly pain evolution during the 5 days after beginning of treatment: pain estimated on visual scale o Proportion of responding patients (improvement estimated at more than 50%) within 3 days after tretament initiation o Proportion of responding patients within 3 days after treatment initiation o Proportion of patients with attack resolution within 5 days after treatment initiation defined by pain improvement >80 % or scale evaluation 50% o Total treatment duration o Number of relapse within the month o Time to first relapse Healthcare consumption : hospitalisation duration relater to gout attck, sick leave duration related to gout attack 2. Anakinra tolerance o Incidence of reaction at the injection site o Incidence of neutropenia and thrombopenia o Mean value of neutropenia and thrombopénia o Incidences of sever infections o Incidence of any adverse event imputable to treatment o Incidnce of cardivascular envents and comorbidity decompensation;Timepoint(s) of evaluation of this end point: LSLV | — |
Countries
France
Contacts
Public ContactProject Manager
Assistance Publique - Hôpitaux de Paris
Outcome results
None listed