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Tests treatment safety and results for IgA Nephropathy (IgAN)
Official title A Study to Evaluate the Long-Term Safety and Efficacy of HSK39297 Tablets in Primary IgA Nephropathy
ClinicalTrials.gov ID: NCT07616700
What this study is testing
What is HSK39297 200mgQD?
HSK39297 200mgQD is an investigational medicine, being studied as a potential treatment for iga nephropathy (igan).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- Completed the HSK39297-202 study and assessed by the investigator to have a favorable benefit-risk profile for 200 mg QD HSK39297.
- eGFR ≥30 mL/min/1.73 m² at screening (calculated by CKD-EPI 2021 equation).
- Able to maintain optimized, stable background therapy with RAS blockers, SGLT2 inhibitors, endothelin receptor antagonists, or hydroxychloroquine...
- Vaccinated against Neisseria meningitidis and Streptococcus pneumoniae as required in the previous study (booster if needed).
- Fertile females: negative serum pregnancy test; highly effective contraception from signing informed consent until 30 days after last dose. Fertile...
You likely can't join if
- Known or suspected hereditary or acquired complement deficiency.
- Active primary or secondary immunodeficiency.
- History of bone marrow / hematopoietic stem cell or solid organ transplantation.
- Malignancy within the past 5 years (except cured basal cell carcinoma of the skin or carcinoma in situ of the cervix).
- History of recurrent invasive infections caused by encapsulated bacteria (e.g., N. meningitidis, S. pneumoniae) or Mycobacterium tuberculosis.
- Severe concomitant diseases judged by the investigator to be incompatible with study participation.
See the full eligibility criteria
- Completed the HSK39297-202 study and assessed by the investigator to have a favorable benefit-risk profile for 200 mg QD HSK39297.
- eGFR ≥30 mL/min/1.73 m² at screening (calculated by CKD-EPI 2021 equation).
- Able to maintain optimized, stable background therapy with RAS blockers, SGLT2 inhibitors, endothelin receptor antagonists, or hydroxychloroquine during the study.
- Vaccinated against Neisseria meningitidis and Streptococcus pneumoniae as required in the previous study (booster if needed).
- Fertile females: negative serum pregnancy test; highly effective contraception from signing informed consent until 30 days after last dose. Fertile males: highly effective contraception from signing informed consent...
- Voluntarily provided written informed consent and able to comply with study procedures
- Known or suspected hereditary or acquired complement deficiency.
- Active primary or secondary immunodeficiency.
- History of bone marrow / hematopoietic stem cell or solid organ transplantation.
- Malignancy within the past 5 years (except cured basal cell carcinoma of the skin or carcinoma in situ of the cervix).
- History of recurrent invasive infections caused by encapsulated bacteria (e.g., N. meningitidis, S. pneumoniae) or Mycobacterium tuberculosis.
- Severe concomitant diseases judged by the investigator to be incompatible with study participation.
- Suspected hypersensitivity to the investigational product or its class.
- Pregnant or lactating females.
- Other conditions that may interfere with the study or increase subject risk.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.