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

NCT04981613 | Completed

• 1 other identifier: KYS2021-03-02-9
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetic Nephropathy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• 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 Outcomes (6)

• 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

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Drug: Kunxian capsule

Control group

NO INTERVENTION

irbesartan tablet (150mg qd or 300mg qd) for 48 weeks

Interventions

Kunxian capsule DRUG

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

Experimental group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

First Affiliated Hospital of Xian Jiaotong University

Xi'an, Shaanxi, 710061, China

Location

MeSH Terms

Conditions

Diabetic Nephropathies

Interventions

kunxian

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2021
• First Posted: July 29, 2021
• Study Start: July 28, 2021
• Primary Completion: August 28, 2024
• Study Completion: August 28, 2024
• Last Updated: August 12, 2025

Record last verified: 2025-03

Locations

CN (1)