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首页> 外文期刊>Journal of nephrology. >Prospective randomized controlled multicenter trial on steroids plus ramipril in proteinuric IgA nephropathy.
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Prospective randomized controlled multicenter trial on steroids plus ramipril in proteinuric IgA nephropathy.

机译：蛋白质IgA肾病患者对类固醇加上ramipril的预期随机控制多中心试验。

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Recent studies have shown that steroids improve renal survival and reduce proteinuria in IgA nephropathy (IgAN) patients with moderate urinary protein excretion and normal renal function. However, this effect seems to diminish over time. Moreover, it has been demonstrated that long-term use of ramipril reduces the risk of end-stage renal disease in proteinuric diabetic and non-diabetic chronic nephropathies. We have planned a long-term unblinded, prospective, centrally randomized, controlled, multicentric trial to assess whether combined treatment of steroids and ramipril is superior to ramipril alone in patients with progressive IgAN disease. A minimum of 134 patients with biopsy-proven IgAN, grade G3 or G4, daily proteinuria > 1.0 g and creatinine clearance > 50 mL/min will be enrolled during a 2-year recruitment period. The patients will be allocated randomly to receive a six-month course of oral prednisone (1.0 mg/Kg/day for 2 months, tapered by 0.2 mg/Kg/day every month) plus ramipril (2.5 mg/day for one month, increased by 1.25 mg/day every month to achieve and maintain a blood pressure less than 120-80 mm Hg and/or to reduce daily proteinuria to 1.0 g or less or by at least 50%) in the experimental group or ramipril alone in the control group. Ramipril will be administered during the whole 5-year follow-up period in both groups. The primary endpoint will be renal survival estimated by 50% increase in baseline serum creatinine; the secondary endpoints will be urinary protein and cytokine excretion and side-effects. Analyses will be done by intention to treat. A p <0.05 will be taken as significant.
机译：最近的研究表明，类固醇改善了IgA肾病（IGAN）患有中度尿蛋白排泄和正常肾功能患者的肾脏存活率和减少蛋白尿。然而，这种效果似乎随着时间的推移而减少。此外，已经证明，长期使用Ramipril降低了蛋白质糖尿病和非糖尿病慢性肾病的终级肾病的风险。我们计划了长期未结合的，前瞻性，集中随机化，控制，多中心试验，以评估类固醇和Ramipril的组合治疗是否优于ramipril，仅在患有渐进式Igan病的患者中。最少134名活组织检查验证的IGAN，级G3或G4患者，每日蛋白尿> 1.0g和肌酐清除> 50 ml / min将在2年招生期间注册。患者将随机分配，以获得六个月的口服泼尼松疗程（每月逐渐逐渐变细0.2毫克/千克/天）加上ramipril（一个月2.5毫克/天，增加每月1.25毫克/天，以在实验组或ramipril中获得小于120-80mm Hg的血压小于120-80mm Hg和/或将每日蛋白尿或至少50％的人减少到控制中团体。 ramipril将在两组的整个5年随访期间进行管理。主要终点将肾脏存活估计基线血清肌酐增加50％;次要终点将是尿蛋白和细胞因子排泄和副作用。分析将通过意图治疗。 P <0.05将被视为显着。

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