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Clinical Trial Details

Trial ID: L0671
Source ID: NCT05687890
Associated Drug: Placebo Of Sc0062
Title: A Study to Evaluate the Efficacy and Safety of SC0062 in the Treatment of Chronic Kidney Disease
Acronym:
Status: ACTIVE_NOT_RECRUITING
Study Results: NO
Results:
Conditions: Diabetic Kidney Disease|IgA Nephropathy
Interventions: DRUG: Placebo of SC0062|DRUG: SC0062 low dose|DRUG: SC0062 medium dose|DRUG: SC0062 high dose
Outcome Measures: Primary: Change in urine albumin creatinine ratio (UACR), Change from baseline at Week 12 in urine albumin creatinine ratio (UACR) in Cohort 1, Week 12|Changes in urine protein creatinine ratio (UPCR), Change from baseline at Week 12 in urine protein creatinine ratio (UPCR) in Cohort 2, Week 12 | Secondary: Change in urine albumin creatinine ratio (UACR) by visit, Change in urine albumin creatinine ratio (UACR) after treatment, Week 2, week 4, week 8, week 12, week 16, week 20, week 24|Change in urine protein creatinine ratio (UPCR) by visit, Change in urine protein creatinine ratio (UPCR) after treatment, Week 2, week 4, week 8, week 12, week 16, week 20, week 24|Changes in glomerular filtration rate (eGFR), Change in glomerular filtration rate (eGFR) from baseline to end of study, Week 2, week 4, week 8, week 12, week 16, week 20, week 24|Change of 24-hour urine albumin excretion rate (UAER), Change of 24-hour urine albumin excretion rate (UAER) at Week 12 and Week 24 in Cohort 1, Week 12, week 24|Change of 24-hour urine protein excretion rate (UPER), Change of 24-hour urine protein excretion rate (UPER) at Week 12 and Week 24 in Cohort 2, Week 12, week 24|Percentage of subjects achieving UACR ≥30%, ≥40%, and ≥50% reduction from baseline, Percentage of subjects achieving UACR ≥30%, ≥40%, and ≥50% reduction at Week 12 and Week 24 in Cohort 1, Week 12, week 24|Percentage of subjects achieving UPCR ≥30%, ≥40%, and ≥50% reduction from baseline, Percentage of subjects achieving UPCR ≥30%, ≥40%, and ≥50% reduction at Week 12 and Week 24 in Cohort 2, Week 12, week 24
Sponsor/Collaborators: Sponsor: Biocity Biopharmaceutics Co., Ltd.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 255
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2023-05-23
Completion Date: 2025-04
Results First Posted:
Last Update Posted: 2025-01-07
Locations: 79 Qingchun Rd.,Shangcheng District, Hangzhou, Zhejiang, 310003, China
URL: https://clinicaltrials.gov/show/NCT05687890