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

NCT ID: NCT04981613

Last Updated: 2025-08-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-28
• Study Completion Date: 2024-08-28

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental group

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

Group Type: EXPERIMENTAL

Kunxian capsule

Intervention Type: DRUG

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

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Kunxian capsule

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

First Affiliated Hospital of Xian Jiaotong University

Xi'an, Shaanxi, China

Countries

China

Other Identifiers

KYS2021-03-02-9

Identifier Type: -

Identifier Source: org_study_id