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NCT Number: NCT04981613

Study on the Efficacy and Safety of a Novel Tripterygium Wilfordii Preparation in Reducing Proteinuria in Patients With Diabetic Nephropathy

The investigators designed a randomized parallel controlled clinical study, selected 98 cases of diabetic nephropathy patients with urinary protein > 1g, randomly assigned into the Kunxian capsule + irbesartan group or irbesartan group, 48 weeks of treatment and follow-up, reduced levels of urinary protein and effective relief time, remission rate as the main end point, estimated glomerular filtration rate (eGFR) drop rate slope for secondary end points, safety events were also collected. To evaluate the efficacy and safety of Kunxian capsule combined with irbesartan in treatment of diabetic nephropathy compared with irbesartan alone.

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Key information

Conditions

Diabetic Nephropathy Diabetes Complications Diabetes Mellitus Diabetic Nephropathies Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

First Affiliated Hospital of Xian Jiaotong University

Xi'an, Shaanxi, 710061, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Conformed to the diagnostic criteria of diabetic nephropathy
  • No gender limitation, age 18-85 years old, no fertility requirement temporarily
  • eGFR: >30ml/min/1.73m2（CKD-EPI）
  • Urine protein >1 g/day
  • No glucocorticoids or/and immunosuppressive therapy was received within 3 months
  • Patients volunteered to participate in this study and signed the informed consent

Exclusion criteria

  • Combined with diabetic acute complications or acute kidney injury (AKI)
  • Combined with other autoimmune diseases
  • Primary and other secondary renal diseases
  • Patients with hypotension (BP < 90/60mmHg) or bilateral renal artery stenosis who are not suitable for angiotensin receptor blockers (ARB) drugs
  • There are contraindications to the use of kunxian capsules or allergic to any of the ingredients in kunxian capsules
  • There are fertility requirements or pregnant, lactation patients
  • Combined with malignant tumor, hepatitis, tuberculosis, HIV, serious infection, rheumatic disease, heart failure, chronic obstructive pulmonary disease (COPD) and other serious systemic diseases
  • Kidney transplant or dialysis has been performed
  • Clinicians deem it inappropriate, or patients are unwilling to sign informed consent, have poor compliance, have a history of mental illness, or cannot complete follow-up visits

Treatment and study plan

kunxian capsule

Drug

Kunxian capsule (2# tid or 2# bid) + irbesartan tablet (150mg qd or 300mg qd) for 48 weeks

Primary outcomes

  1. Changed levels of urinary protein, gram

    Time frame: 48 weeks

  2. The effective remission time of urinary protein, day

    Time frame: 48 weeks

  3. Urinary protein remission rate, %

    Time frame: 48 weeks

Secondary outcomes

  1. 24-hour urinary protein quantity, gram

    Time frame: 48 weeks

  2. Urinary albumin/creatinine ratio

    Time frame: 48 weeks

  3. eGFR decline rate slope

    Time frame: 48 weeks

  4. Number of participants achieving end stage renal disease (ESRD) or requiring dialysis or kidney transplantation, or blood creatinine doubling, or renal death, or all-cause death, %

    Time frame: 48 weeks

  5. Time of participants achieving end stage renal disease (ESRD) or requiring dialysis or kidney transplantation, or blood creatinine doubling, or renal death, or all-cause death, days

    Time frame: 48 weeks

Other outcomes

  1. Number of participants with treatment-related adverse events as assessed by bone marrow suppression, %

    Time frame: 48 weeks

  2. Number of participants with treatment-related adverse events as assessed by liver damage, %

    Time frame: 48 weeks

  3. Number of participants with treatment-related adverse events as assessed by infection, %

    Time frame: 48 weeks

  4. Number of participants with treatment-related adverse events as assessed by gastrointestinal reactions, %

    Time frame: 48 weeks

  5. Number of participants with treatment-related adverse events as assessed by skin damage, %

    Time frame: 48 weeks

  6. Number of participants with treatment-related adverse events as assessed by reproductive toxicity (menorrhea or amenorrhea or infertility), %

    Time frame: 48 weeks

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital Xi'an Jiaotong University

Other

Registry information

Official study title

RCT Study on the Efficacy and Safety of a Novel Tripterygium Wilfordii Preparation in Reducing Proteinuria in Patients With Diabetic Nephropathy

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jul 29, 2021
Registry last updated
Aug 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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