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

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetic Nephropathy

Intervention / Treatment
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* Drug: Kunxian capsule


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 |