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

Xi'an Jiaotong University

Status: Completed

Conditions: Diabetic Nephropathy

Treatments: Drug: Kunxian capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT04981613

KYS2021-03-02-9

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Experimental group

Experimental group

Description:

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

Treatment:

Drug: Kunxian capsule

Control group

No Intervention group

Description:

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