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Background Idiopathic membranous nephropathy (IMN) is one of the most common primary glomerular diseases in China, especially in the elderly. Patients who are classified as low risk of renal function decline based on KDIGO guidelines often present with obvious lower extremities edema, which make the supportive treatment of RAS inhibitors less accepted. Tripterygium wilfordii multiglycosides has been used to treat rheumatic disease over years in China, and has been demonstrated to have the effect of reducing proteinuria and alleviate edema in patients with chronic kidney disease. Methods This is an open-labeled, randomized, controlled clinical trial. Twenty patients with IMN who meet the inclusive criteria will be randomly assigned into the intervention group and the control group at a rate of 1:1. The intervention group was treated with tripterygium wilfordii multiglycosides tablets (1-1.5mg/kg body weight, oral administration after three meals) in addition to the original dose of ACEi/ARB, while the control group continued with the original dose of ACEi/ARB. The treatment course is six months, and the clinical data of patients will be collected at baseline and at each monthly follow-up. The primary outcome measure is the absolute value of relative baseline decrease of urinary protein quantity after six months treatment. The secondary outcome measures include absolute value of relative baseline decrease of ACR in morning urine after 6 months treatment, the percentage of patients who reached the standard of effective clinical treatment, and complex renal end point events. Safety outcome measures include the incidence of adverse events, the incidence of serious adverse events, changes in laboratory safety indicators, and death. Discussion This study aims to provide higher-level evidence of evidence-based medicine for tripterygium wilfordii multiglycosides in the treatment of this disease, and hopefully has important significance for clinicians who are to make therapeutic decisions of IMN. Trial Registration: This trial has been prospectively registered in Chinese Clinical Trial Registry (identifier# ChiCTR2100048382) on 6 July 2021. Trial status: Recruiting. Recruitment is expected to be completed in June 2020. |
