Diabetic nephropathy (DN) is a leading cause of end-stage kidney disease worldwide and is associated with a high risk of cardiovascular events and mortality. Despite current standard therapies including renin-angiotensin system inhibitors (ACEI/ARB), glycemic control, and blood pressure management, disease progression remains inadequately controlled in many patients.
Naoxintong Capsule is a traditional Chinese medicine formulation composed of 16 herbal ingredients (Astragalus membranaceus, Prunus persica seed, Carthamus tinctorius, Paeonia lactiflora, Angelica sinensis, Ligusticum chuanxiong, Boswellia carterii, Commiphora myrrha, Salvia miltiorrhiza, Achyranthes bidentata, Cinnamomum cassia, Morus alba, Spatholobus suberectus, Buthus martensii, Pheretima aspergillum, and Hirudo nipponica). It has been widely used in China for cardiovascular and cerebrovascular diseases, with demonstrated effects on endothelial protection, anti-inflammation, anti-thrombosis, and plaque stabilization.
This multicenter, randomized, double-blind, placebo-controlled trial aims to evaluate the efficacy and safety of Naoxintong Capsule added to standard conventional therapy in slowing the progression of diabetic nephropathy and providing cardiovascular protection. A total of 410 patients with Type 2 diabetic nephropathy will be randomized (1:1) to receive either Naoxintong Capsules (4 capsules, 3 times daily) or matching placebo, in addition to standard therapy, for 12 months. The primary outcome is the annual rate of decline in estimated glomerular filtration rate (eGFR). Secondary outcomes include changes in proteinuria, CKD stage progression, time to end-stage kidney disease, major adverse cardiovascular events, TCM syndrome scores, and quality of life measures.
Age >= 18 years.
Confirmed diagnosis of Type 2 diabetes mellitus; AND
At least one of the following: urinary albumin-to-creatinine ratio (UACR) >= 30 mg/g, or eGFR < 60 mL/min/1.73m², confirmed by repeat testing (interval >= 3 months), after excluding transient factors such as acute kidney injury, dehydration, infection, or heart failure; OR
Renal biopsy confirmed as isolated diabetic nephropathy; AND
Type 1 diabetes mellitus or other types of diabetes mellitus (e.g., secondary diabetes, maturity-onset diabetes of the young).
Coexisting systemic autoimmune or immune-mediated disease where the clinical assessment suggests a non-diabetic nephropathy etiology.
Decline in eGFR of > 30% within the past 3 months.
Persistent serum potassium > 5.5 mmol/L.
Parallel
Naoxintong Capsule
DrugNaoxintong Capsule is a traditional Chinese medicine formulation composed of 16 herbal and animal-derived ingredients: Astragalus membranaceus (Huangqi), Prunus persica seed (Taoren), Carthamus tinctorius flower (Honghua), Paeonia lactiflora root (Chishao), Angelica sinensis root (Danggui), Ligusticum chuanxiong rhizome (Chuanxiong), Boswellia carterii resin (Ruxiang), Commiphora myrrha resin (Moyao), Salvia miltiorrhiza root (Danshen), Achyranthes bidentata root (Niuxi), Cinnamomum cassia twig (Guizhi), Morus alba twig (Sangzhi), Spatholobus suberectus stem (Jixueteng), Buthus martensii (Quanxie), Pheretima aspergillum (Dilong), and Hirudo nipponica (Shuizhi). Each capsule contains 0.4 g of active ingredients. Dosage: 4 capsules (1.6 g) per dose, taken orally 3 times daily, 30-60 minutes after meals. Manufactured by Shaanxi Buchang Pharmaceutical Co., Ltd. (National Drug Approval No.: Guoyaozhunzi Z20025001). Storage: sealed, at room temperature. Shelf life: 24 months.
Placebo
DrugMatching placebo capsules identical in appearance, size, shape, color, weight, packaging, and labeling to Naoxintong Capsules but containing no active pharmaceutical or herbal ingredients. Dosage: 4 capsules per dose, taken orally 3 times daily, 30-60 minutes after meals. Manufactured by Shaanxi Buchang Pharmaceutical Co., Ltd. Storage: sealed, at room temperature. Shelf life: 24 months.
Annual Rate of Decline in Estimated Glomerular Filtration Rate (eGFR)
The annual rate of decline in eGFR (ml/min/1.73m\^2/year), calculated as the slope of eGFR over the 12-month treatment period using all available eGFR measurements at each scheduled visit. eGFR is estimated using the CKD-EPI equation. A less negative slope indicates slower disease progression.
Change in 24-Hour Urinary Protein Excretion From Baseline
Change from baseline in 24-hour urinary protein excretion (g/24h), measured at each scheduled visit. A decrease indicates renal protective effect.
Renal Composite Endpoint: eGFR Decline >30%, ESKD, or MACE
Time to first occurrence of: sustained eGFR decline \>30% from baseline; end-stage kidney disease; or major adverse cardiovascular event.
Proportion of Participants With CKD Stage Improvement, Stabilization, or Progression
Proportion of participants whose CKD stage (KDIGO eGFR categories) improved, remained stable, or progressed.
Time to Sustained eGFR Decline of Greater Than 30% From Baseline
Time from randomization to first confirmed sustained eGFR decline exceeding 30% from baseline.
Time to End-Stage Kidney Disease (ESKD)
Time from randomization to ESKD: maintenance dialysis, kidney transplantation, or sustained eGFR \<15.
Time to First Unplanned Hospitalization for Heart Failure
Time from randomization to first unplanned hospital admission primarily due to heart failure.
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Chen Xiangmei
Lead sponsor
Chinese PLA General Hospital
Sponsor institution
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