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

RCT 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.

Study Overview

• Status: Completed
• Conditions: Diabetic Nephropathy
• Intervention / Treatment: Drug: Kunxian capsule

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710061
      • First Affiliated Hospital of Xian Jiaotong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; Kunxian capsule (2# tid or 2# bid) + irbesartan tablet (150mg qd or 300mg qd) for 48 weeks	Drug: Kunxian capsule; Kunxian capsule (2# tid or 2# bid) + irbesartan tablet (150mg qd or 300mg qd) for 48 weeks
No Intervention: Control group; irbesartan tablet (150mg qd or 300mg qd) for 48 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changed levels of urinary protein, gram	48 weeks
The effective remission time of urinary protein, day	48 weeks
Urinary protein remission rate, %	48 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
24-hour urinary protein quantity, gram	48 weeks
Urinary albumin/creatinine ratio	48 weeks
eGFR decline rate slope	48 weeks
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, %	48 weeks
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	48 weeks

Other Outcome Measures

Outcome Measure	Time Frame
Number of participants with treatment-related adverse events as assessed by bone marrow suppression, %	48 weeks
Number of participants with treatment-related adverse events as assessed by liver damage, %	48 weeks
Number of participants with treatment-related adverse events as assessed by infection, %	48 weeks
Number of participants with treatment-related adverse events as assessed by gastrointestinal reactions, %	48 weeks
Number of participants with treatment-related adverse events as assessed by skin damage, %	48 weeks
Number of participants with treatment-related adverse events as assessed by reproductive toxicity (menorrhea or amenorrhea or infertility), %	48 weeks

Collaborators and Investigators

• Sponsor: First Affiliated Hospital Xi'an Jiaotong University

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2021
• Primary Completion (Actual): August 28, 2024
• Study Completion (Actual): August 28, 2024

Study Registration Dates

• First Submitted: July 1, 2021
• First Submitted That Met QC Criteria: July 27, 2021
• First Posted (Actual): July 29, 2021

Study Record Updates

• Last Update Posted (Actual): August 12, 2025
• Last Update Submitted That Met QC Criteria: August 7, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Urological Manifestations; Diabetes Mellitus; Diabetes Complications; Kidney Diseases; Diabetic Nephropathies; Proteinuria
• Other Study ID Numbers: KYS2021-03-02-9

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No