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Kidney Week

Abstract: SA-PO0856

A Randomised Controlled Trial of Tripterygium wilfordii Polyglycoside in the Long-Term Treatment of Stage 4 Diabetic Nephropathy

Session Information

Category: Glomerular Diseases

  • 1402 Glomerular Diseases: Clinical, Outcomes, and Therapeutics

Authors

  • Mao, Yong Hui, Beijing Hospital Department of Nephrology, Beijing, China
  • Zhao, Ban, Beijing Hospital Department of Nephrology, Beijing, China
Background

Tripterygium wilfordii polyglycosides (TWP) significantly reduces proteinuria and improves renal outcomes in type 2 DN. To evaluate the efficacy and safety of long-term TWP treatment in patients with stage IV Diabetic Nephropathy (DN).

Methods

In a single-center, prospective randomized controlled trial (ChiCTR-IOR-17010623), DN patients on ARB were randomized to ARB alone or ARB plus TWP (titrated to 30–90 mg/day). Primary endpoint: ≥30% reduction in proteinuria at 48 weeks. Secondary endpoints included all-cause and cardiovascular mortality, progression to ESRD or need for renal replacement therapy, and doubling of serum creatinine or rise ≥442 μmol/L after 4 weeks. Analyses followed intention-to-treat. Extended follow-up (median ~206 weeks) assessed long-term renal outcomes.

Results

Among 49 randomized patients, TWP+ARB significantly reduced 24-hour proteinuria versus ARB in the overall population, with a greater proportion achieving ≥30% reduction and a significant group×time interaction in linear mixed models (P<0.001). In the biopsy-confirmed subgroup (n=24), similar but more pronounced treatment effects were observed, with sustained proteinuria decline and favorable trajectory differences (P<0.001). eGFR remained stable with TWP+ARB but declined significantly under ARB in both the total cohort and subgroup; a significant interaction confirmed divergent renal function trajectories (P=0.046). Long-term follow-up suggested fewer ESRD events in TWP+ARB, without a statistically significant survival difference.

Conclusion

The addition of TWP to ARB therapy significantly reduced proteinuria and stabilized renal function in stage IV Diabetic Nephropathy, with a trend toward long-term renal protection and an acceptable safety profile.