MedTrace Logo

A Study to Evaluate the Long-Term Safety and Efficacy of HSK39297 Tablets in Primary IgA Nephropathy

NCT07616700 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2026-06-01

No results posted yet for this study

Summary

This is a Phase II, multicenter, open-label study. Eligible subjects who have completed the HSK39297-202 study will be enrolled.Starting dose is 200 mg QD.Dose may be increased to 300 mg QD after 8-12 weeks of stable 200 mg QD therapy if 24-h urine protein excretion (UPE) remains \>1 g/24 h and no Grade ≥3 treatment-related adverse events (AEs) occur.After the treatment period, subjects will enter the 4-week safety follow-up period.

Conditions

  • IgA Nephropathy (IgAN)

Interventions

DRUG

HSK39297 200mgQD

Dose may be increased to 300 mg QD after 8-12 weeks of stable 200 mg QD therapy if 24-h urine protein excretion (UPE) remains \>1 g/24 h and no Grade ≥3 treatment-related adverse events (AEs) occur.

DRUG

HSK39297 300mgQD

Dose may be increased to 300 mg QD after 8-12 weeks of stable 200 mg QD therapy if 24-h urine protein excretion (UPE) remains \>1 g/24 h and no Grade ≥3 treatment-related adverse events (AEs) occur.

Sponsors & Collaborators

  • Haisco Pharmaceutical Group Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-25
Primary Completion
2026-12-05
Completion
2026-12-26

Countries

  • China

Study Locations

More Related Trials

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 NCT07616700 on ClinicalTrials.gov