Abstract
BackgroundChronic 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/designThis 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.DiscussionThe 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.Trial registrationThis trial was registered on 12 February 2014 at ClinicalTrials.gov (ID number NCT02063100).Electronic supplementary materialThe online version of this article (doi:10.1186/1745-6215-15-479) contains supplementary material, which is available to authorized users.
Highlights
Chronic kidney disease is a common disease
Losartan potassium is one of the earliest angiotensin II receptor blockers (ARB) used to treat Chronic kidney disease (CKD) based on large amounts of research-derived data regarding its ability to decrease proteinuria and exert renoprotective effects [25,26,27,28,29,30,31]
The inclusion criteria are a diagnosis of primary glomerulonephritis, aged 18 to 70 years, blood pressure ≤140/ 90 mmHg, estimated glomerular filtration rate ≥45 mL/ min/1.73 m2, 24-hour proteinuria level of 0.5 to 3.0 g, traditional Chinese medicine syndrome conforming to Qi-Yin deficiency, and agreement to participate by the patient or their guardians with written informed consent
Summary
Primary glomerulonephritis is a major cause of CKD [40,41,42]. Effective control of proteinuria and protection of kidney function play key roles for the treatment of CKD. An important feature of this study is that participants have a wide geographical distribution and many participating sites are included; poor generalization resulting from a narrow geographical distribution and single center can be avoided, allowing for relatively good generalization and applicability The results of this trial will provide solid evidence for evaluation of the efficacy and safety of SYKFT versus losartan potassium in controlling proteinuria in patients with primary glomerulonephritis. YSX participated in the conception and design of the study and reviewed the manuscript critically for intellectual content. XMC conceived the idea of the study and designed the protocol, drafted the initial manuscript, participated in critical revision of the manuscript for important intellectual content, and is responsible for the overall management and conduct of study.
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