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.
Shengnan Chen, Yajuan Gao, Zishen Liang et al.
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In 30 seconds
This 48-week randomized controlled trial assigned 80 patients with diabetic kidney disease to irbesartan-based standard therapy with or without adjunctive Kunxian capsule. In the intention-to-treat analysis, proteinuria remission occurred in 57.50% with Kunxian versus 25.00% with irbesartan alone; median time to remission was 5 months versus not reached. The Kunxian group also had a greater reduction in 24-hour urinary protein, slower eGFR decline, and fewer renal composite hard endpoints. Adverse-event incidence did not differ significantly between groups.
Key findings
- Proteinuria remission was 57.50% with Kunxian plus irbesartan versus 25.00% with irbesartan alone.
- Median time to proteinuria remission was 5 months with Kunxian versus not reached in the control group.
- Renal composite hard endpoints occurred in 10.00% versus 32.50%, respectively, with slower eGFR decline in the Kunxian group.
- Adverse-event incidence did not differ significantly between groups.
Why it matters
Persistent proteinuria and progressive loss of kidney function remain concerns in diabetic kidney disease despite renin-angiotensin system blockade. This trial reports improvements in proteinuria outcomes and renal measures when Kunxian was added to irbesartan, while observed adverse-event incidence was similar. The findings provide clinical evidence for further evaluation of this adjunctive approach, but do not establish its broader effectiveness or safety.
What to keep in mind
The trial included 80 patients and followed them for 48 weeks; the abstract does not provide effect estimates or uncertainty measures for the reported outcomes.