Clinical trial NCT04981613: Study on the Efficacy and Safety of a Novel Tripterygium Wilfordii Preparation in Reducing Proteinuria in Patients With Diabetic Nephropathy
Official title: RCT Study on the Efficacy and Safety of a Novel Tripterygium Wilfordii Preparation in Reducing Proteinuria in Patients With Diabetic Nephropathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetic Nephropathy
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2021-07-29
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Changed levels of urinary protein, gram
timeFrame: 48 weeks
measure: The effective remission time of urinary protein, day
timeFrame: 48 weeks
measure: Urinary protein remission rate, %
timeFrame: 48 weeks
Secondary outcomes:
measure: 24-hour urinary protein quantity, gram
timeFrame: 48 weeks
measure: Urinary albumin/creatinine ratio
timeFrame: 48 weeks
measure: eGFR decline rate slope
timeFrame: 48 weeks
measure: 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, %
timeFrame: 48 weeks
measure: 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
timeFrame: 48 weeks
Other outcomes:
measure: Number of participants with treatment-related adverse events as assessed by bone marrow suppression, %
timeFrame: 48 weeks
measure: Number of participants with treatment-related adverse events as assessed by liver damage, %
timeFrame: 48 weeks
measure: Number of participants with treatment-related adverse events as assessed by infection, %
timeFrame: 48 weeks
measure: Number of participants with treatment-related adverse events as assessed by gastrointestinal reactions, %
timeFrame: 48 weeks
measure: Number of participants with treatment-related adverse events as assessed by skin damage, %
timeFrame: 48 weeks
measure: Number of participants with treatment-related adverse events as assessed by reproductive toxicity (menorrhea or amenorrhea or infertility), %
timeFrame: 48 weeks
Locations:
city: Xi'an
country: China
facility: First Affiliated Hospital of Xian Jiaotong University
state: Shaanxi
Study officials:
References: