Kou Jia, Wu Jie, Yang Hong-tao, He Ya-ni, Fang Jing-ai, Deng Yue-yi, Xie Yuan-sheng, Nie Li-fang, Lin Hong-li, Cai Guang-yan, Chen Xiang-mei
Department of Nephrology, Chinese PLA General Hospital, Chinese PLA Institute of Nephrology, State Key Laboratory of Kidney Diseases, National Clinical Research Center of Kidney Diseases, 28 Fuxing Road, Haidian District, Beijing 100853, China.
Trials. 2014 Dec 5;15:479. doi: 10.1186/1745-6215-15-479.
Chronic kidney disease is a common disease. Most chronic kidney diseases evolve from primary glomerulonephritis. Proteinuria is an independent risk factor for the progression of chronic kidney disease. The general consensus is that therapy administered to decrease proteinuria should include steroids and/or immunosuppressants, angiotensin-converting enzyme inhibitors, and angiotensin II receptor blockers. However, the side effects of, and adverse reactions to, these agents reduce the benefits to patients. In addition, the cost of these drugs is relatively high. Therefore, identification of inexpensive and effective drugs to decrease proteinuria is urgently needed. Shenyankangfu tablets have been a widely applied Chinese patent medicine for many years to decrease proteinuria. However, there is a lack of research-derived data regarding the clinical use. Therefore, we designed the present randomized controlled clinical trial to compare the efficacy and safety of Shenyankangfu tablets versus losartan potassium for control of proteinuria in patients with primary glomerulonephritis.
METHODS/DESIGN: This study will be a multicenter, prospective, double-blind, double-dummy, randomized controlled clinical trial. We will enroll 720 patients diagnosed with primary glomerulonephritis. The eligible patients will be randomly divided into the following groups at a 1:1:1:1:1 ratio: Shenyankangfu tablets group, losartan potassium 50 mg group, losartan potassium 100 mg group, Shenyankangfu tablets + losartan potassium 50 mg group, and Shenyankangfu tablets + losartan potassium 100 mg group. All groups will be followed up for 48 weeks; follow-up visits will be performed, at weeks 0, 4, 8, 12, 24, 36, and 48. The primary efficacy outcome will be the post-treatment change in the 24-hour proteinuria level, and the secondary efficacy outcomes will be the post-treatment changes in the serum creatinine level, estimated glomerular filtration rate, traditional Chinese medicine syndrome score, and serum albumin level.
The results of this trial will provide solid data for use in evidence-based medicine with respect to the efficacy and safety of Shenyankangfu tablets for control of proteinuria in patients with primary glomerulonephritis compared to those of losartan potassium. Moreover, we infer that therapy comprising Shenyankangfu tablets + losartan potassium can decrease proteinuria to a larger extent than Shenyankangfu tablets or losartan potassium can alone.
This trial was registered on 12 February 2014 at ClinicalTrials.gov (ID number NCT02063100).
慢性肾脏病是一种常见疾病。大多数慢性肾脏病由原发性肾小球肾炎演变而来。蛋白尿是慢性肾脏病进展的独立危险因素。目前的普遍共识是，用于降低蛋白尿的治疗应包括类固醇和/或免疫抑制剂、血管紧张素转换酶抑制剂以及血管紧张素II受体阻滞剂。然而，这些药物的副作用和不良反应降低了对患者的益处。此外，这些药物的成本相对较高。因此，迫切需要鉴定出价格低廉且有效的降低蛋白尿的药物。肾康复片作为一种广泛应用多年的中成药用于降低蛋白尿。然而，缺乏关于其临床应用的研究数据。因此，我们设计了本随机对照临床试验，以比较肾康复片与氯沙坦钾对原发性肾小球肾炎患者蛋白尿的控制效果及安全性。
方法/设计：本研究将是一项多中心、前瞻性、双盲、双模拟、随机对照临床试验。我们将招募720例诊断为原发性肾小球肾炎的患者。符合条件的患者将按1:1:1:1:1的比例随机分为以下几组：肾康复片组、氯沙坦钾50毫克组、氯沙坦钾100毫克组、肾康复片 + 氯沙坦钾50毫克组以及肾康复片 + 氯沙坦钾100毫克组。所有组将随访48周；随访将在第0、4、8、12、24、36和48周进行。主要疗效指标将是治疗后24小时蛋白尿水平的变化，次要疗效指标将是治疗后血清肌酐水平、估计肾小球滤过率、中医证候评分和血清白蛋白水平的变化。
本试验结果将为基于证据的医学提供可靠数据，以比较肾康复片与氯沙坦钾对原发性肾小球肾炎患者蛋白尿的控制效果及安全性。此外，我们推断肾康复片 + 氯沙坦钾联合治疗比单独使用肾康复片或氯沙坦钾能更大程度地降低蛋白尿。
本试验于2014年2月12日在ClinicalTrials.gov注册（注册号NCT02063100）。
