This is a phase II study to investigate the safety, preliminary efficacy and pharmacokinetics of SC0062 capsule in patients with chronic kidney disease (diabetic kidney disease and IgA nephropathy)with albuminuria compared to matching placebo.
This multicenter, randomized, double blind, placebo parallel controlled, 2 cohorts phase II study will contain 2 cohorts: Cohort 1: diabetic kidney disease Cohort 2: biopsy-proven IgAN In each cohort, approximately 120 patients will be randomized to receive SC0062 or placebo daily for 24 weeks. The objective of this study is to evaluate the preliminary efficacy and safety of SC0062 capsules compared to placebo in patients with chronic kidney disease (diabetic kidney disease and IgA nephropathy) with albuminuria who are treated with the maximum tolerated labeled dose renin-angiotensin system inhibitor (RASi).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
255
Subjects will take two capsules daily of one of those which are SC0062 low dose, SC0062 medium dose, SC0062 high dose or placebo for 24 weeks during the treatment period
Subjects will take two capsules daily of one of those which are SC0062 low dose, SC0062 medium dose, SC0062 high dose or placebo for 24 weeks during the treatment period
Subjects will take two capsules daily of one of those which are SC0062 low dose, SC0062 medium dose, SC0062 high dose or placebo for 24 weeks during the treatment period
79 Qingchun Rd.,Shangcheng District
Hangzhou, Zhejiang, China
Change in urine albumin creatinine ratio (UACR)
Change from baseline at Week 12 in urine albumin creatinine ratio (UACR) in Cohort 1
Time frame: Week 12
Changes in urine protein creatinine ratio (UPCR)
Change from baseline at Week 12 in urine protein creatinine ratio (UPCR) in Cohort 2
Time frame: Week 12
Change in urine albumin creatinine ratio (UACR) by visit
Change in urine albumin creatinine ratio (UACR) after treatment
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Week 12, week 24
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Subjects will take two capsules daily of one of those which are SC0062 low dose, SC0062 medium dose, SC0062 high dose or placebo for 24 weeks during the treatment period
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
Time frame: 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
Time frame: Week 12, week 24