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Naoxintong Capsule for Diabetic Nephropathy With Dampness Retention Pattern: A Multicenter, Randomized, Double-Blind, Placebo-Controlled TrialAcronymNXT-DKD (NXT-DKD)

2026年7月8日 更新者：Chen Xiangmei

Evidence-Based Evaluation of Naoxintong Capsule in the Treatment of Diabetic Nephropathy With Dampness Retention Pattern: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial

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.

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

BACKGROUND AND RATIONALE

Diabetic nephropathy (DN) is the leading cause of chronic kidney disease (CKD) and end-stage kidney disease (ESKD) in economically developed countries. China has the largest diabetic population globally, and DN now accounts for approximately 30% of new dialysis patients. Despite the beneficial effects of ACE inhibitors (ACEI) and Angiotensin II receptor blockers (ARB) in the microalbuminuric stage, landmark trials (RENNAL, IDNT, VA NEPHRON-D) have shown that these agents alone or in combination fail to significantly reduce cardiovascular events and all-cause mortality in advanced DN. There is an urgent need for novel therapeutic approaches to slow DN progression and improve survival.

Naoxintong Capsule (National Drug Approval No.: Guoyaozhunzi Z20025001) is a well-established traditional Chinese medicine formulation that has been widely used in China for cardiovascular and cerebrovascular diseases. It comprises 16 herbal and animal-derived ingredients that collectively exert effects through endothelial protection, anti-inflammatory activity, inhibition of thrombosis, and plaque stabilization. Based on the integrative medicine concept of brain-heart-kidney co-treatment and the shared pathophysiological mechanisms underlying DN progression and cardiovascular complications, Naoxintong Capsule represents a promising adjunctive therapy for DN.

STUDY DESIGN AND OBJECTIVES

This is a multicenter, randomized, double-blind, placebo-controlled clinical trial designed to provide high-level evidence for the efficacy and safety of Naoxintong Capsule in treating DN. The study will enroll 410 adult patients with confirmed Type 2 diabetic nephropathy across approximately 20 clinical centers in China.

The primary objective is to evaluate whether adding Naoxintong Capsule to standard conventional therapy can slow the annual rate of eGFR decline compared with standard therapy alone (with placebo). Secondary objectives include assessing effects on proteinuria, CKD stage progression, time to ESKD, cardiovascular events, traditional Chinese medicine (TCM) syndrome scores, and health-related quality of life.

PARTICIPANT POPULATION

Eligible participants are adults (age >= 18 years) with confirmed Type 2 diabetic nephropathy, 24-hour urinary protein excretion between 0.5 and 3.5 g, eGFR >= 45 mL/min/1.73m2, and on stable ACEI/ARB therapy for at least 8 weeks prior to enrollment. Patients must discontinue all other traditional Chinese medicine products for a washout period of at least 4 weeks before randomization.

INTERVENTION

Participants will be randomized (1:1) to receive either Naoxintong Capsules or matching placebo capsules, both administered as 4 capsules per dose, 3 times daily, taken orally 30 to 60 minutes after meals. All participants continue to receive standard conventional therapy for DN, including glycemic control, blood pressure management, lipid-lowering therapy, dietary management, and treatment of CKD-related complications as clinically indicated. The treatment duration is 12 months.

FOLLOW-UP AND ASSESSMENTS

Following randomization at Visit 1 (V1), participants will attend scheduled visits at Month 1 (V2), Month 3 (V3), Month 6 (V4), Month 9 (V5), and Month 12 (V6). At each visit, clinical assessments include physical examination, laboratory tests (urinalysis, 24-hour urine protein, urine albumin-to-creatinine ratio, complete blood count, blood biochemistry including renal function, HbA1c, lipid profile, hs-CRP, IL-6), ECG, TCM syndrome scoring, and adverse event monitoring. At selected visits (V1, V6), additional imaging studies (chest X-ray/CT, renal ultrasound) and optional fundoscopy are performed. Biological samples (blood, urine, stool) are collected at V1, V4, and V6 for exploratory analyses including gut microbiota and metabolomics.

SAMPLE SIZE

The sample size of 410 (205 per group) was calculated based on detecting a clinically meaningful difference of 1.0 mL/min/1.73m2/year in eGFR annual decline slope between groups (expected: -3.0 vs. -2.0 mL/min/1.73m2/year), with a pooled standard deviation of 3.2, at a two-sided alpha of 0.05 and 80% power, allowing for a 20% dropout rate.

STATISTICAL ANALYSIS

Efficacy analyses will be conducted on both the Full Analysis Set (FAS, intention-to-treat) and the Per-Protocol Set (PPS). The primary analysis will use a mixed-effects model for the eGFR slope, adjusting for center effect. Time-to-event outcomes will be analyzed using Kaplan-Meier methods and Cox proportional hazards models. Safety analyses will be performed on the FAS.

研究の種類

介入

入学 (推定)

410

段階

  • フェーズ 4

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • 中国
    • Beijing Municipality
      • Beijing、Beijing Municipality、中国
        • China-Japan Friendship Hospital
        • コンタクト：
      • Beijing、Beijing Municipality、中国、100853
        • Chinese PLA General Hospital, First Medical Center
        • コンタクト：
    • Chongqing Municipality
      • Chongqing、Chongqing Municipality、中国
        • Daping Hospital, Army Medical University
        • コンタクト：
    • Liaoning
      • Dalian、Liaoning、中国
        • First Affiliated Hospital of Dalian Medical University
        • コンタクト：
    • Shanghai Municipality
      • Shanghai、Shanghai Municipality、中国
        • Renji Hospital, Shanghai Jiao Tong University School of Medicine
        • コンタクト：
      • Shanghai、Shanghai Municipality、中国
        • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
        • コンタクト：
      • Shanghai、Shanghai Municipality、中国
        • Longhua Hospital, Shanghai University of Traditional Chinese Medicine
        • コンタクト：
    • Zhejiang
      • Hangzhou、Zhejiang、中国
        • Zhejiang Provincial Hospital of Traditional Chinese Medicine
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

Inclusion Criteria:

  1. Age >= 18 years.

  2. Meets the diagnostic criteria for Type 2 diabetic nephropathy, defined as:

    1. Confirmed diagnosis of Type 2 diabetes mellitus; AND
    2. At least one of the following: urinary albumin-to-creatinine ratio (UACR) >= 30 mg/g, or eGFR < 60 mL/min/1.73m^2, confirmed by repeat testing (interval >= 3 months), after excluding transient factors such as acute kidney injury, dehydration, infection, or heart failure; OR
    3. Renal biopsy confirmed as isolated diabetic nephropathy; AND
    4. Exclusion of other primary or secondary kidney diseases.
  3. 24-hour urinary protein excretion >= 0.5 g and < 3.5 g.
  4. Estimated glomerular filtration rate (eGFR) >= 45 mL/min/1.73m^2.
  5. On a stable dose of ACE inhibitor (ACEI) or Angiotensin II receptor blocker (ARB) therapy for at least 8 weeks prior to enrollment. If SGLT2 inhibitors, mineralocorticoid receptor antagonists (MRA), or GLP-1 receptor agonists are being used, the dose must have been stable for at least 4 weeks prior to enrollment and remain unchanged during the study period. Patients not currently using these agents must not initiate them during the study.
  6. Signed informed consent form.

Exclusion Criteria:

  1. Type 1 diabetes mellitus or other types of diabetes mellitus (e.g., secondary diabetes, maturity-onset diabetes of the young).
  2. Coexisting systemic autoimmune or immune-mediated disease where the clinical assessment suggests a non-diabetic nephropathy etiology.
  3. Decline in eGFR of > 30% within the past 3 months.
  4. Persistent serum potassium > 5.5 mmol/L.
  5. Diagnosis of hemorrhagic cardiovascular or cerebrovascular disease within the past 3 months.
  6. Known allergy or hypersensitivity to any component of Naoxintong Capsule or placebo; pregnant or lactating women.
  7. Participation in another drug or medical device clinical trial within the past 6 months.
  8. Any other condition that, in the investigator's judgment, renders the patient unsuitable for participation in the clinical trial (e.g., severe hepatic dysfunction, life expectancy < 1 year).

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：ダブル

武器と介入

参加者グループ / アーム
介入・治療
実験的：Naoxintong Capsule Group
Participants will receive Naoxintong Capsules (4 capsules per dose, 3 times daily, orally, 30-60 minutes after meals) in addition to standard conventional therapy for diabetic nephropathy, for a total treatment duration of 12 months. Standard conventional therapy includes glycemic control (oral hypoglycemic agents and/or insulin), blood pressure management (ACEI or ARB, with optional non-RASI antihypertensives), lipid-lowering therapy (statins as indicated), dietary management (protein 0.6-0.8 g/kg/day, sodium <3 g/day), and treatment of CKD-related complications as clinically indicated.
薬：Naoxintong Capsule
Naoxintong 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.
プラセボコンパレーター：Placebo Group
Participants will receive matching placebo capsules (4 capsules per dose, 3 times daily, orally, 30-60 minutes after meals) in addition to standard conventional therapy for diabetic nephropathy, for a total treatment duration of 12 months. Standard conventional therapy is identical to that provided in the Naoxintong group.
薬：Placebo
Matching 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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Annual Rate of Decline in Estimated Glomerular Filtration Rate (eGFR)
時間枠：Baseline to Month 12
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.
Baseline to Month 12
Change in 24-Hour Urinary Protein Excretion From Baseline
時間枠：Baseline to Month 12
Change from baseline in 24-hour urinary protein excretion (g/24h), measured at each scheduled visit. A decrease indicates renal protective effect.
Baseline to Month 12
Renal Composite Endpoint: eGFR Decline >30%, ESKD, or MACE
時間枠：From randomization through Month 12
Time to first occurrence of: sustained eGFR decline >30% from baseline; end-stage kidney disease; or major adverse cardiovascular event.
From randomization through Month 12

二次結果の測定

結果測定
メジャーの説明
時間枠
Proportion of Participants With CKD Stage Improvement, Stabilization, or Progression
時間枠：Baseline to Month 12
Proportion of participants whose CKD stage (KDIGO eGFR categories) improved, remained stable, or progressed.
Baseline to Month 12
Time to Sustained eGFR Decline of Greater Than 30% From Baseline
時間枠：From randomization through Month 12
Time from randomization to first confirmed sustained eGFR decline exceeding 30% from baseline.
From randomization through Month 12
Time to End-Stage Kidney Disease (ESKD)
時間枠：From randomization through Month 12
Time from randomization to ESKD: maintenance dialysis, kidney transplantation, or sustained eGFR <15.
From randomization through Month 12
Time to First Unplanned Hospitalization for Heart Failure
時間枠：From randomization through Month 12
Time from randomization to first unplanned hospital admission primarily due to heart failure.
From randomization through Month 12
Time to First Non-Fatal Myocardial Infarction
時間枠：From randomization through Month 12
Time from randomization to first non-fatal MI per WHO-MONICA criteria.
From randomization through Month 12
Time to First Non-Fatal Ischemic Stroke
時間枠：From randomization through Month 12
Time from randomization to first non-fatal ischemic stroke with imaging confirmation.
From randomization through Month 12
Time to Cardiovascular Death or Stroke-Related Death
時間枠：From randomization through Month 12
Time from randomization to death attributable to cardiovascular or cerebrovascular causes.
From randomization through Month 12
Time to All-Cause Death
時間枠：From randomization through Month 12
Time from randomization to death from any cause.
From randomization through Month 12
Change in TCM Syndrome Score From Baseline
時間枠：Baseline to Month 12
Change in TCM syndrome score using a standardized 90-item questionnaire.
Baseline to Month 12

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Chen Xiangmei

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2027年3月1日

一次修了 (推定)

2028年6月1日

研究の完了 (推定)

2028年12月30日

試験登録日

最初に提出

2026年7月8日

QC基準を満たした最初の提出物

2026年7月8日

最初の投稿 (実際)

2026年7月13日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月13日

QC基準を満たした最後の更新が送信されました

2026年7月8日

最終確認日

2026年7月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • NXT-DKD-2026-001

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

De-identified individual participant data (IPD) may be shared with qualified researchers upon reasonable request, subject to a data use agreement, following publication of the primary results.

IPD 共有時間枠

After publication of primary results

IPD 共有アクセス基準

Via reasonable request with data use agreement

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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