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

Diabetic Nephropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04981613
• Other study ID #: KYS2021-03-02-9
• Status: Recruiting
• Phase: N/A
• Start date: July 28, 2021
• Est. completion date: August 2024

Study information

• Verified date: June 2023
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Yan Shen, MD, PHD
• Phone: 0086-18991978269
• Email: shenyan66[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 98
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Nephropathies
• Diabetic Nephropathy
• Kidney Diseases
• Proteinuria

Intervention

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

Locations

Country	Name	City	State
China	First Affiliated Hospital of Xian Jiaotong University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of participants with treatment-related adverse events as assessed by bone marrow suppression, %		48 weeks
Other	Number of participants with treatment-related adverse events as assessed by liver damage, %		48 weeks
Other	Number of participants with treatment-related adverse events as assessed by infection, %		48 weeks
Other	Number of participants with treatment-related adverse events as assessed by gastrointestinal reactions, %		48 weeks
Other	Number of participants with treatment-related adverse events as assessed by skin damage, %		48 weeks
Other	Number of participants with treatment-related adverse events as assessed by reproductive toxicity (menorrhea or amenorrhea or infertility), %		48 weeks
Primary	Changed levels of urinary protein, gram		48 weeks
Primary	The effective remission time of urinary protein, day		48 weeks
Primary	Urinary protein remission rate, %		48 weeks
Secondary	24-hour urinary protein quantity, gram		48 weeks
Secondary	Urinary albumin/creatinine ratio		48 weeks
Secondary	eGFR decline rate slope		48 weeks
Secondary	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
Secondary	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