NCT05687890

A Study to Evaluate the Efficacy and Safety of SC0062 in the Treatment of Chronic Kidney Disease

A Randomized, Double Blind, Placebo Parallel Controlled, 2 Cohorts, Multicenter Phase II Study to Investigate the Safety and Efficacy of SC0062 Capsule in Patients With Chronic Kidney Disease With Albuminuria

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 255 (actual)
• Sponsor: Biocity Biopharmaceutics Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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).

Conditions

• Diabetic Kidney Disease
• IgA Nephropathy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-05-23
• Primary completion: 2024-11-30
• Completion: 2025-04-01
• First posted: 2023-01-18
• Last updated: 2025-01-07

Locations

1 site across 1 country: China