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A Study of SC0062 Capsule for the Treatment of IgA Nephropathy with Proteinuria

NCT06819826 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2025-02-17

No results posted yet for this study

Summary

This is a multicenter, randomized, double-blind, placebo-controlled Phase III study to evaluate the efficacy and safety of SC0062 capsule compared to placebo in patients with IgA nephropathy in the presence of proteinuria. The participants must have a high risk of disease progression, despite of stable use of the maximum tolerated labelled or optimized dose of RAASi and/or SGLT2i for at least 12 weeks prior to randomization.

Conditions

  • IgA Nephropathy (IgAN)

Interventions

DRUG

SC0062 strength 10mg

Subjects will take 20 mg once daily for 108 weeks during the treatment period.

DRUG

Placebo matched to SC0062

Subjects will take 20 mg once daily for 108 weeks during the treatment period.

Sponsors & Collaborators

  • Biocity Biopharmaceutics Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-14
Primary Completion
2026-12-31
Completion
2028-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06819826 on ClinicalTrials.gov