Study on the Efficacy and Safety of a Novel Tripterygium Wilfordii Preparation in Reducing Proteinuria in Patients With Diabetic Nephropathy
Not Applicable
Recruiting
- Conditions
- Diabetic Nephropathy
- Interventions
- Drug: Kunxian capsule
- Registration Number
- NCT04981613
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 98
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental group Kunxian capsule Kunxian capsule (2# tid or 2# bid) + irbesartan tablet (150mg qd or 300mg qd) for 48 weeks
- Primary Outcome Measures
Name Time Method Urinary protein remission rate, % 48 weeks Changed levels of urinary protein, gram 48 weeks The effective remission time of urinary protein, day 48 weeks
- Secondary Outcome Measures
Name Time Method 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 Urinary albumin/creatinine ratio 48 weeks 24-hour urinary protein quantity, gram 48 weeks
Trial Locations
- Locations (1)
First Affiliated Hospital of Xian Jiaotong University
🇨🇳Xi'an, Shaanxi, China