A Study to Evaluate the Efficacy and Safety of SC0062 in the Treatment of Chronic Kidney Disease
NCT05687890 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 255
Last updated 2025-01-07
Summary
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.
Conditions
- Diabetic Kidney Disease
- IgA Nephropathy
Interventions
- DRUG
-
Placebo of SC0062
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
- DRUG
-
SC0062 low dose
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
- DRUG
-
SC0062 medium dose
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
- DRUG
-
SC0062 high dose
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
Sponsors & Collaborators
-
Biocity Biopharmaceutics Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Jianghua Chen, Prof · Zhejiang University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-05-23
- Primary Completion
- 2024-11-30
- Completion
- 2025-04-30
Countries
- China
Study Locations
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