The China-Australia International Research Centre for Chinese Medicine, School of Health and Biomedical Sciences, RMIT University, Melbourne, VIC, Australia.
State Key Laboratory of Dampness Syndrome of Chinese Medicine, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.
Front Endocrinol (Lausanne). 2024 Feb 8;15:1334609. doi: 10.3389/fendo.2024.1334609. eCollection 2024.
Diabetic kidney disease (DKD) has become the leading cause of kidney failure, causing a significant socioeconomic burden worldwide. The usual care for DKD fails to achieve satisfactory effects in delaying the persistent loss of renal function. A Chinese herbal medicine, (TQF), showed preliminary clinical benefits with a sound safety profile for people with stage 2-4 DKD. We present the protocol of an ongoing clinical trial investigating the feasibility, efficacy, and safety of TQF compared to placebo in delaying the progressive decline of renal function for people with stage 2-4 DKD.
A mixed methods research design will be used in this study. A randomized, double-blind, placebo-controlled pilot trial will evaluate the feasibility, efficacy, and safety of TQF compared to placebo on kidney function for people with stage 2-4 DKD. An embedded semi-structured interview will explore the acceptability of TQF granules and trial procedures from the participant's perspective. Sixty eligible participants with stage 2-4 DKD will be randomly allocated to the treatment group (TQF plus usual care) or the control group (TQF placebo plus usual care) at a 1:1 ratio for 48-week treatment and 12-week follow-up. Participants will be assessed every 12 weeks. The feasibility will be assessed as the primary outcome. The changes in the estimated glomerular filtration rate, urinary protein/albumin, renal function, glycemic and lipid markers, renal composite endpoint events, and dampness syndrome of Chinese medicine will be assessed as the efficacy outcomes. Safety outcomes such as liver function, serum potassium, and adverse events will also be evaluated. The data and safety monitoring board will be responsible for the participants' benefits, the data's credibility, and the results' validity. The intent-to-treat and per-protocol analysis will be performed as the primary statistical strategy.
Conducting a rigorously designed pilot trial will be a significant step toward establishing the feasibility and acceptability of TQF and trial design. The study will also provide critical information for future full-scale trial design to further generate new evidence supporting clinical practice for people with stage 2-4 DKD.
https://www.chictr.org.cn/, identifier ChiCTR2200062786.
糖尿病肾病（DKD）已成为全球范围内导致肾衰竭的主要原因，造成了巨大的社会经济负担。通常的 DKD 治疗方法在延缓持续的肾功能丧失方面效果并不理想。一种中药，（TQF），在 2-4 期 DKD 患者中显示出初步的临床获益，且安全性良好。我们提出了一项正在进行的临床试验方案，该试验旨在研究 TQF 与安慰剂相比在延缓 2-4 期 DKD 患者肾功能进行性下降方面的可行性、疗效和安全性。
本研究采用混合方法研究设计。一项随机、双盲、安慰剂对照的初步试验将评估 TQF 与安慰剂相比对 2-4 期 DKD 患者肾功能的疗效和安全性。一项嵌入式半结构式访谈将从参与者的角度探讨 TQF 颗粒和试验程序的可接受性。60 名符合条件的 2-4 期 DKD 患者将以 1:1 的比例随机分配到治疗组（TQF 加常规治疗）或对照组（TQF 安慰剂加常规治疗），进行 48 周的治疗和 12 周的随访。参与者将每 12 周进行一次评估。可行性将作为主要结局进行评估。肾小球滤过率估计值、尿蛋白/白蛋白、肾功能、血糖和血脂标志物、肾脏复合终点事件以及中医湿证的变化将作为疗效结局进行评估。还将评估肝功能、血清钾和不良事件等安全性结局。数据和安全监测委员会将负责评估参与者的获益、数据的可信度和结果的有效性。意向治疗和方案分析将作为主要的统计策略。
开展一项严格设计的初步试验将是朝着确定 TQF 的可行性和可接受性以及试验设计迈出的重要一步。该研究还将为未来的全面试验设计提供关键信息，以进一步为 2-4 期 DKD 患者的临床实践提供新的证据支持。
https://www.chictr.org.cn/，注册号 ChiCTR2200062786。
