Effect of Kunxian capsule, a novel Tripterygium wilfordii preparation, on reducing proteinuria and slowing renal function decline in diabetic kidney disease: a 48-week randomized controlled trial
In brief
Kunxian capsule raised proteinuria remission from 25% to 58% in a small trial
Among 80 patients with diabetic kidney disease, adding Kunxian capsule to irbesartan for 48 weeks increased proteinuria remission from 25% to 57.5% and was associated with slower kidney function decline and fewer renal composite events. Adverse event rates did not differ, but the small, short trial leaves benefits and safety over longer-term use uncertain.
- Journal
- Renal failure (Q1)
- Published
- 4 November 2026
- Study design
- Randomized controlled trial
- Evidence level
- Level 1, High (CEBM 1b)
- Authors
- Shengnan Chen, Yajuan Gao, Zishen Liang, Yixue Zhang, Cui Wang, Yali Tang, et al.
- PMID
- 42978535
- DOI
- 10.1080/0886022X.2026.2755136
Why clinicians should know about it
- Picked for Nephrology (paper of the day, 8 November 2026): 48‑week RCT, proteinuria remission, slower eGFR decline
Abstract
BACKGROUND: Diabetic kidney disease (DKD), a leading cause of chronic kidney disease, remains a clinical challenge despite renin-angiotensin system blockade. This study evaluated the efficacy and safety of adding Kunxian capsule to standard therapy with irbesartan in patients with DKD. METHODS: Eighty patients with DKD were randomly assigned to either the experimental group (standard therapy with irbesartan plus Kunxian capsule) or the control group (standard therapy with irbesartan) for 48 weeks. Primary outcomes included the proteinuria remission rate, degree of proteinuria reduction, and median time to remission. Secondary outcomes included the slope of eGFR decline and the incidence of renal composite hard endpoint. Safety was assessed by monitoring adverse events. This trial was registered in ClinicalTrials.gov on March 2, 2021 (No. NCT04981613). RESULTS: In the intention-to-treat analysis, the experimental group had a higher proteinuria remission rate (57.50% vs. 25.00%), a shorter median time to remission (5 months vs. not reached), and a greater reduction in 24-hour urinary protein than the control group. A lower incidence of renal composite hard endpoint was observed in the experimental group (10.00% vs. 32.50%), accompanied by a slower eGFR decline. No significant differences in the incidence of adverse events were observed between the two groups. Inflammatory markers, including C-reactive protein and erythrocyte sedimentation rate, were significantly reduced in the experimental group. CONCLUSIONS: Adding Kunxian capsule to standard therapy with irbesartan improved the proteinuria remission rate and attenuated renal function decline in patients with DKD, supporting its potential as a promising adjunctive therapy.
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.