Randomized, Multicentric Study Evaluating the Efficacy and the Safety of Methylprednisolone Bolus in the Treatment of Renal Sarcoidosis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Percentage of patients with a positive response defined by eGRF better than 100% compared to eGRF prior treatment or a normalization of renal function.
研究概览
简要总结
Renal sarcoidosis treatment is based on steroids, but the dose and duration are unknown. Despite this treatment, most patients will have chronic kidney disease. From our previous studies, the investigators believe that high dose steroids by methylprednisolone bolus will improve patient outcome and renal function.
详细描述
In a multicentric, randomized, open trial, the investigators will assess the efficacy of methylprednisolone bolus at 15mg/kg/d for 3 days before oral steroids on renal function improvement in renal sarcoidosis patients.
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
- None
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
- •Age ≥ 18 years
- •Acute kidney injury with estimated glomerular filtration rate (eGFR) < 60 mL/min/1,73 m2, defined by an increase of initial value > 25% or an increase of > 30 µmol/l, since at least 3 months.
- •Sarcoidosis diagnostic criteria according to ATS/ERS/WASOG (Am J Respir Crit Care Med 1999)
- •Renal biopsy compatible with renal sarcoidosis :
- •Granulomatosis tubulo-interstitial nephropathy and extra-renal damage of histologically proved or suggestive sarcoidosis Or
- •Tubulo-interstitial nephropathy without granuloma and extra-renal damage of histologically proved sarcoidosis
- •Informed consent
- •Patients with social security
排除标准
- •Corticosteroids greater than 0,25 mg/kg/j prednisone equivalent
- •Introduction of an immunosuppressant in the month before inclusion
- •Another cause of renal granulomatosis or tubulo-interstitial nephropathy
- •Isolated renal damage without extra-renal past or present damage for a sarcoidosis
- •Chronic renal failure, prior sarcoidosis with eGFR < 30 mL/min/1,73 m2
- •Acute renal failure from other causes. If hypercalcaemia is greater than 3 mmol/L, the correction of any dehydration will systematically salt intake, followed of renal function control before inclusion.
- •Pregnancy, nursing
- •Tuberculosis
- •Uncontrolled sepsis
- •Uncontrolled psychotic state
- •Hypersensibility to methylprednisolone hemisuccinate
- •Drugs prescription causing wave burst arrhythmia and/or long QT on ECG
研究组 & 干预措施
methylprednisolone bolus
methylprednisolone bolus 15 mg/kg/d for 3 days before oral prednisone 1 mg/kg/d for 30 days and progressive tapering of steroids, to get 0,5 mg/kg/d at M3 and 0,25 mg/kg/d at M6 and 5-10 mg at M12.
干预措施: methylprednisolone bolus IV 15 mg/kg/d for 3 days. (Drug)
结局指标
主要结局
Percentage of patients with a positive response defined by eGRF better than 100% compared to eGRF prior treatment or a normalization of renal function.
时间窗: 3 months after the beginning of the treatment
次要结局
- Efficacy (eGFR, percentage of patients with a eGRF < 60 ml/min/1.73m²)(1, 3, 6 and 12 months after the beginning of the treatment)
- Extra-renal manifestations(1, 3, 6 and 12 months after the beginning of the treatment)
- incidence of arrhythmias and cardiac conduction disease(1, 3, 6 and 12 months after the beginning of the treatment)
- fragility fracture(1, 3, 6 and 12 months after the beginning of the treatment)
- neuro-psychiatric troubles and infections(1, 3, 6 and 12 months after the beginning of the treatment)
- number of renal and extra-renal relapses.(1, 3, 6 and 12 months after the beginning of the treatment)
- Characterization of vitamin and calcium deficiencies by blood and urinary dosages(1, 3, 6 and 12 months after the beginning of the treatment)