Logo 1 Logo 2

Clinical Trial Details

Trial ID: L0443
Source ID: NCT04349683
Associated Drug: Jinshuibao
Title: Efficacy and Safety of Jinshuibao for Patients With Chronic Kidney Disease Due to Glomerulonephritis
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Chronic Kidney Disease Stage 3B|Chronic Kidney Disease stage4|Glomerulonephritis
Interventions: DRUG: Jinshuibao|DRUG: Placebo
Outcome Measures: Primary: 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: 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
Sponsor/Collaborators: Sponsor: Jemincare | Collaborators: Shanghai 6th People's Hospital
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 332
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2020-04-30
Completion Date: 2021-10-30
Results First Posted:
Last Update Posted: 2020-04-20
Locations:
URL: https://clinicaltrials.gov/show/NCT04349683