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

Recruiting Phase 3 Interventional Study
IgA Nephropathy (IgAN)
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
360 (estimated)
Sponsor
Biocity Biopharmaceutics Co., Ltd. · Industry
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About This Trial
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 w…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Voluntarily sign informed consent and fully understand and comply with trial procedures; * Age ≥18 years old, gender unlimited; * IgA nephropathy patients with proteinuria must meet all of the following conditions: 1. According to the Chronic Kidney Disease Epidemiology Col…
Contacts

Yu Xueqing, Prof

020-838-27812

yuxueqing@gdph.org.cn

CONTACT

Ye Zhiming, Prof

86+13826161678

Yezhiming@gdph.org.cn

CONTACT