Treatment for reducing protein levels in diabetic nephropathy patients

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

This study is testing if adding a new capsule to the standard diabetes medication can help reduce protein levels in the urine for people with diabetic kidney disease.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 98 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: First Affiliated Hospital Xi'an Jiaotong University (other)
• Locations: 1 site (Xi'an, Shaanxi)
• Trial ID: NCT04981613 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of a novel preparation called Kunxian capsule in combination with irbesartan for patients suffering from diabetic nephropathy. A total of 98 patients with proteinuria greater than 1g/day will be randomly assigned to receive either the combination treatment or irbesartan alone over a period of 48 weeks. The primary endpoint is the reduction of urinary protein levels, while secondary endpoints include the rate of decline in estimated glomerular filtration rate (eGFR) and safety assessments. The study aims to determine if the addition of Kunxian capsule enhances treatment outcomes compared to standard therapy.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-85 with diagnosed diabetic nephropathy and urinary protein levels exceeding 1g/day.

Not a fit: Patients with acute kidney injury, other autoimmune diseases, or contraindications to the study medications will not benefit from this trial.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce proteinuria and improve kidney function in patients with diabetic nephropathy.

How similar studies have performed: While this approach is novel, similar studies have shown promise in using herbal preparations alongside conventional treatments for chronic kidney diseases.

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

Where this trial is running

Xi'an, Shaanxi

• First Affiliated Hospital of Xian Jiaotong University — Xi'an, Shaanxi, China (RECRUITING)

Study contacts

• Study coordinator: Yan Shen, MD, PHD

Conditions: Diabetic Nephropathy