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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
332
6 capsules at a time, 3 times a day (tid).
6 capsules at a time, 3 times a day (tid).
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
Time frame: Baseline to 48 weeks
Change of surem creatinine and 24-hour urine protein
Surem creatinine (Scr) will be tested by a central laboratory
Time frame: Baseline to 12 weeks, 24 weeks, 36 weeks, 48 weeks
Change of urinary protein/creatinine ratio (PCR)
Change from baseline in PCR
Time frame: Baseline to 12 weeks, 24 weeks, 36 weeks, 48 weeks
Change of hs-CRP
Change from baseline in hs-CRP
Time frame: 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
Time frame: 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
Time frame: 48 weeks
Patients' Quality of life
Patients' Quality of life will be accessed by KDQOL-36 (Chinese Version)
Time frame: Baseline to 24 weeks and 48 weeks
Number of rehospitalizations
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Number of rehospitalizations during the follow-up period
Time frame: 48 weeks