Efficacy and Safety of Jinshuibao for Patients With Chronic Kidney Disease Due to Glomerulonephritis

Study Overview
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Brief Summary
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This is a multicenter, double-blind randomized controlled study to assess the efficacy and safety of Jinshuibao for patients with CKD due to glomerulonephritis, with a planned follow-up of 48 weeks.

Detailed Description
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Previous studies have shown that cordyceps sinensis can act on several immune response pathways. Jinshuibao capsule, which is composed of fermented cordyceps sinensis powder (Cs-4) , has shown therapeutic effects in chronic kidney disease (CKD) according to small sample exploratory studies. Here, we conduct a prospective, double-blind randomized controlled study to assess the efficacy and safety of Jinshuibao for patients with CKD due to glomerulonephritis.

Official Title
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Efficacy and Safety of Jinshuibao for Patients With Chronic Kidney Disease Due to Glomerulonephritis：A Multicenter Randomized Controlled Clinical Trial

Conditions
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Chronic Kidney Disease Stage 3B, Chronic Kidney Disease stage4, Glomerulonephritis

Intervention / Treatment
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* Drug: Jinshuibao
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged >= 18 years old and <= 70 years old. Patients with chronic kidney disease caused by primary glomerulonephritis diagnosed by previous pathology or diagnosed by clinician. Chronic kidney disease stage 3b-4, that is, patients with eGFR between 15 and 45 ml/min per 1.73 m2 (according to 2012 KDIGO standard). 24-hour urinary protein < 3g during the screening period. Blood pressure, glucose, lipid and uric acid were measured during the screening period and were all in the following range: blood pressure: systolic blood pressure <140 and diastolic blood pressure < 90 mmHg; fasting blood-glucose < 8.0mmol/L or HbA1c < 8.0%; LDLl-c < 100 mg /dl (2.59 mmol/L), and TC < 230 mg /dl (5.95 mmol/L); uric acid < 420 mol/L. Patients who have signed the informed consent. Exclusion Criteria: Pregnant or lactating women, or women of reproductive age who are unwilling to take reliable contraceptive measures. Allergy to Jinshuibao. Treatment with natural cordyceps sinensis, artificial cordyceps sinensis, traditional Chinese medicine or proprietary Chinese medicine with known renal impairment in recent 2 weeks. Treatment with glucocorticoids, immunosuppressants or tripterygium wilfordii preparations in recent 3 months, or patients who have been confirmed to be treated with glucocorticoids, immunosuppressants or tripterygium wilfordii preparations in the following months. History of gastrointestinal impairment or gastrointestinal diseases which may significantly affect the absorption of the experimental drugs, such as confirmed active ulcer (Forrest grade II or more severe impairment), inflammatory bowel disease, malabsorption syndrome, uncontrollable diarrhea or history of gastrointestinal surgery. History of organ transplant, including kidney transplant. History of severe diseases of the heart, brain, liver, hematopoietic system or other serious diseases affecting survival, such as malignant tumors, myocardial infarction, unstable angina, stroke or transient ischemic attack in recent 6 months. Patients whose disease progresses too rapidly judged by the clinician. Enrolled in other trials in recent 3 months. Patients who are assessed by investigator as unsuitable for inclusion.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>basic treatment combined with Jinshuibao | Drug: Jinshuibao<br>* 6 capsules at a time, 3 times a day (tid).<br>* Other names: basic treatment;|
| Placebo Comparator: Control group<br>basic treatment and placebo | Drug: Placebo<br>* 6 capsules at a time, 3 times a day (tid).<br>* Other names: basic treatment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of estimated glomerular filtration rate | Estimated Glomerular Filtration Rate (eGFR) will be calculated according to Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) creatinine equation | Baseline to 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of surem creatinine and 24-hour urine protein | Surem creatinine (Scr) will be tested by a central laboratory | Baseline to 12 weeks, 24 weeks, 36 weeks, 48 weeks | 
| Change of urinary protein/creatinine ratio (PCR) | Change from baseline in PCR | Baseline to 12 weeks, 24 weeks, 36 weeks, 48 weeks | 
| Change of hs-CRP | Change from baseline in hs-CRP | Baseline to 24 weeks, 48 weeks | 
| Change of TNF-α, IL-1β, and IL-6 | Change from baseline in TNF-α, IL-1β, and IL-6 | Baseline to 24 weeks and 48 weeks | 
| Time to decline of 50% in eGFR or development of ESRD, and incidence of decline of 50% in eGFR or development of ESRD | End stage renal disease (ESRD）is defined by the need for long-term dialysis or renal transplantation, or eGFR<15ml/min | 48 weeks | 
| Patients' Quality of life | Patients' Quality of life will be accessed by KDQOL-36 (Chinese Version) | Baseline to 24 weeks and 48 weeks | 
| Number of rehospitalizations | Number of rehospitalizations during the follow-up period | 48 weeks |