Anakinra vs Prednisone to Treat Gout Flare in Patients With Chronic Kidney Disease Stage 4/5 or Renal Transplantation: a Randomized, Double Blinded, Multicenter Study
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 入组人数
- 204
- 试验地点
- 1
- 主要终点
- Pain difference between Day 3 and treatment initiation
研究概览
简要总结
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 with colchicine, non-steroid anti-inflammatory drugs (NSAID), corticosteroid or interleukin (IL)-1b blockade. Colchicine and NSAID are contra-indicated in patients with chronic renal disease (CKD) stage 4/5 or with renal transplantation. In these patients gout flare is treated with high dose of corticosteroid or IL-1b inhibitors.
Frequent use of high dose of corticosteroid can worsen gout comorbidities including mellitus diabetes type 2, hypertension, obesity and dyslipidemia. Anakinra, an IL-1b receptor antagonist, is efficient in gout flare in patients without CKD stage 4/5.
The aim of this study is to demonstrate that anakinra is superior to prednisone to treat gout flare in patients with CKD 4/5 or renal transplantation.
详细描述
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 flare and CKD 4/5 or renal transplantation will be included and randomized to receive either anakinra 100 mg/d or prednisone 30 mg/d.
-Visit from day (d)0 to d5: included patients will be hospitalized and treatment will be administrated by a nurse. Treatment will be stopped if patient had ≥ 80% improvement. Treatment response is defined by improvement ≥ 50%.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Anakinra
Anakinra 100 mg/d+Placebo of Prednisone
干预措施: Anakinra 100Mg/0.67Ml Inj Syringe (Drug)
Anakinra
Anakinra 100 mg/d+Placebo of Prednisone
干预措施: Placebo of Prednisone (Drug)
Prednisone
Prednisone 30 mg/d+Placebo of Anakinra
干预措施: Prednisone (Drug)
Prednisone
Prednisone 30 mg/d+Placebo of Anakinra
干预措施: Placebo of Anakinra (Drug)
结局指标
主要结局
Pain difference between Day 3 and treatment initiation
时间窗: Day 3
Pain difference between day 3 and treatment initiation assessed by visual analogical scale (VAS) from 0 to 10 VAS = 0, no pain VAS =10, maximal pain
次要结局
- Treatment duration(Day3 or Day 5)
- Comorbidity decompensations at month 1: Hypertension(Month 1)
- Comorbidity decompensations at month 1: Blood analysis of C reactive protein (CRP)(Month 1)
- Duration of hospitalization(Day 3 or Day 5)
- Healthcare consumption at month 1 : number of consultations and hospitalizations related to gout flare(Month 1)
- Healthcare consumption at month 1: total hospital stay(Month 1)
- Percentage of responders (improvement ≥ 50%) at day 5(Day 5)
- Time to treatment response(Day 3 or Day 5)
- Healthcare consumption at month 1(Month 1)
- Comorbidity decompensations at month 1 : DT2 decompensation(Month 1)
- Percentage of flare resolution (improvement ≥ 80%) at day 5(Day 5)
- Side effects(Month 1)
- Comorbidity decompensations at month 1: Blood pressure(Month 1)
- Time to flare resolution(Day 3 or Day 5)
- Comorbidity decompensations at month 1: Blood analysis of epidermal Growth Factor Receptor (eGFR)(Month 1)
- Comorbidity decompensations at month 1: Weight(Month 1)
- Comorbidity decompensations at month 1: number of Cardiovascular events : coronary disease, heart attack, stroke(Month 1)
- Comorbidity decompensations at month 1: Blood analysis of serum creatinine level(Month 1)
- Comorbidity decompensations at month 1: Blood analysis of HbA1C(Month 1)
- Comorbidity decompensations at month 1: Blood analysis of total cholesterol(Month 1)
- Comorbidity decompensations at month 1: Blood analysis of HDL cholesterol(Month 1)
- Comorbidity decompensations at month 1: Blood analysis of triglyceride(Month 1)
- Comorbidity decompensations at month 1: Blood analysis of glycaemia(Month 1)
- site injection reaction during day 0 to day 5: pain(Dat 3 or day 5)
- Comorbidity decompensations at month 1: Blood analysis of LDL cholesterol(Month 1)
- site injection reaction during day 0 to day 5: itching (yes/no)(Dat 3 or day 5)
- site injection reaction during day 0 to day 5: inflammatory reaction(Dat 3 or day 5)
- site injection reaction during day 0 to day 5: redness (yes/no)(Dat 3 or day 5)
- site injection reaction during day 0 to day 5: swelling (yes/no)(Dat 3 or day 5)