NCT04981613Completed
Study on the Efficacy and Safety of a Novel Tripterygium Wilfordii Preparation in Reducing Proteinuria in Patients With Diabetic Nephropathy
RCT Study on the Efficacy and Safety of a Novel Tripterygium Wilfordii Preparation in Reducing Proteinuria in Patients With Diabetic Nephropathy
Source: ClinicalTrials.gov · Last updated 12 Aug 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 80 (actual)
- First submitted
- 1 Jul 2021
- Start date
- 28 Jul 2021
- Primary completion date
- 28 Aug 2024
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong University
- Diseases
- Chronic kidney disease
- NCT number
- NCT04981613
What you commit to
- Study type: Interventional
- Participants enrolled: 80
- From 28 Jul 2021 to the primary completion date, 28 Aug 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with hypotension (BP \< 90/60mmHg) or bilateral renal artery stenosis who are not suitable for angiotensin receptor blockers (ARB) drugs
- Kidney transplant or dialysis has been performed
Other illness
- Combined with other autoimmune diseases
- Primary and other secondary renal diseases
- There are contraindications to the use of kunxian capsules or allergic to any of the ingredients in kunxian capsules
- Combined with malignant tumor, hepatitis, tuberculosis, HIV, serious infection, rheumatic disease, heart failure, chronic obstructive pulmonary disease (COPD) and other serious systemic diseases
- 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
Other
- Combined with diabetic acute complications or acute kidney injury (AKI)
- There are fertility requirements or pregnant, lactation patients
Who the study is looking for
- 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
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| First Affiliated Hospital of Xian Jiaotong University Coordinator of this site? Confirm its status | Xi'an | China | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.