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Tests treatment safety and results for IgA Nephropathy (IgAN)
Official title Phase Ⅲ Study of Efficacy and Safety of HSK39297 Tablet in Treatment of Patients With Primary IgAN
ClinicalTrials.gov ID: NCT07390123
What this study is testing
What is HSK39297?
HSK39297 is an investigational medicine, given as an once-daily pill taken by mouth, 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
- Evaluate the efficacy and safety of HSK39297 tablets in patients with primary IgAN
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- people must have signed and dated an IRB/IEC approved written informed consent form.people must be willing and able to comply with scheduled visits...
- Female and male patients above 18 years of age.
- Patients must weigh at least 35 kg to participate in the study, and must have a body mass index (BMI) below 35 kg/m2. BMI = Body weight (kg) /...
- people with a biopsy-verified IgA nephropathy and where the biopsy was performed within the prior ten years.
- 24h-UPCR ≥0.75g/g or 24h-UPE≥1.0g/24h at screening.
You likely can't join if
- Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 90 days, whichever is longer.
- All transplanted patients (any organ, including bone marrow).
- History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in-situ cervical cancer).
- Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may...
- Pregnant or nursing (lactating) women.
- Plasma donation (≥ 400mL) within 12 weeks prior to first dosing.
See the full eligibility criteria
- people must have signed and dated an IRB/IEC approved written informed consent form.people must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, tumor biopsies, and other...
- Female and male patients above 18 years of age.
- Patients must weigh at least 35 kg to participate in the study, and must have a body mass index (BMI) below 35 kg/m2. BMI = Body weight (kg) / [Height (m)]2
- people with a biopsy-verified IgA nephropathy and where the biopsy was performed within the prior ten years.
- 24h-UPCR ≥0.75g/g or 24h-UPE≥1.0g/24h at screening.
- Measured Glomerular Filtration Rate (GFR) or estimated GFR (using the CKD-EPI formula 2021) ≥30 mL/min per 1.73 m2.For patients with eGFR\ 20 to \<30ml/min/1.73m2, a qualifying biopsy performed in two years.
- Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 90 days, whichever is longer.
- All transplanted patients (any organ, including bone marrow).
- History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in-situ cervical cancer).
- Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the subject in case of participation in the study.
- Pregnant or nursing (lactating) women.
- Plasma donation (≥ 400mL) within 12 weeks prior to first dosing.
The study team makes the final eligibility decision.
Where it's taking place
- Huangshan City, Anhui, China
- Wuhu, Anhui, China
- Beijing, Beijing Municipality, China
- Zhanjiang, Guangdong, China
- Changsha, Hunan, China
- Changchun, Jilin, China
- Linyi, Shandong, China
- Shanghai, Shanghai Municipality, China
- Xi’an, Shanxi, 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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Huangshan City, Anhui, China; Wuhu, Anhui, China; Beijing, Beijing Municipality, China; Zhanjiang, Guangdong, China; Changsha, Hunan, China; Changchun, Jilin, China and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
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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.