Clinical trial NCT04349683: Efficacy and Safety of Jinshuibao for Patients With Chronic Kidney Disease Due to Glomerulonephritis
Official title: Efficacy and Safety of Jinshuibao for Patients With Chronic Kidney Disease Due to Glomerulonephritis：A Multicenter Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Chronic Kidney Disease Stage 3B
Chronic Kidney Disease stage4
Glomerulonephritis
Lead sponsor: Jemincare
Sponsor class: INDUSTRY
Collaborators: name: Shanghai 6th People's Hospital
First posted: 2020-04-16
Enrollment: 332
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. Aged \>= 18 years old and \<= 70 years old.
2. Patients with chronic kidney disease caused by primary glomerulonephritis diagnosed by previous pathology or diagnosed by clinician.
3. 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).
4. 24-hour urinary protein \< 3g during the screening period.
5. 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.
6. Patients who have signed the informed consent.

Exclusion Criteria:

1. Pregnant or lactating women, or women of reproductive age who are unwilling to take reliable contraceptive measures.
2. Allergy to Jinshuibao.
3. Treatment with natural cordyceps sinensis, artificial cordyceps sinensis, traditional Chinese medicine or proprietary Chinese medicine with known renal impairment in recent 2 weeks.
4. 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.
5. 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.
6. History of organ transplant, including kidney transplant.
7. 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.
8. Patients whose disease progresses too rapidly judged by the clinician.
9. Enrolled in other trials in recent 3 months.
10. Patients who are assessed by investigator as unsuitable for inclusion.

Primary outcomes:
measure: Change of estimated glomerular filtration rate
timeFrame: Baseline to 48 weeks
Secondary outcomes:
measure: Change of surem creatinine and 24-hour urine protein
timeFrame: Baseline to 12 weeks, 24 weeks, 36 weeks, 48 weeks
measure: Change of urinary protein/creatinine ratio (PCR)
timeFrame: Baseline to 12 weeks, 24 weeks, 36 weeks, 48 weeks
measure: Change of hs-CRP
timeFrame: Baseline to 24 weeks, 48 weeks
measure: Change of TNF-α, IL-1β, and IL-6
timeFrame: Baseline to 24 weeks and 48 weeks
measure: Time to decline of 50% in eGFR or development of ESRD, and incidence of decline of 50% in eGFR or development of ESRD
timeFrame: 48 weeks
measure: Patients' Quality of life
timeFrame: Baseline to 24 weeks and 48 weeks
measure: Number of rehospitalizations
timeFrame: 48 weeks
Other outcomes:
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