IgA Nephropathy study: HSK39297
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?
This is an investigational tablet being studied as a potential treatment for IgA nephropathy.
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 study aims to find out if the new medicine works well and is safe for treating IgA nephropathy.
- Who it's for
- The study is looking for adults who have been diagnosed with primary IgA nephropathy.
- What's involved
- Participants will take the HSK39297 tablet and visit the clinic for check-ups and tests to monitor their health.
- Time commitment
- The source text does not specify the total duration or the number of required visits.
- 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.
- 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 is enrolling
- 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, but 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?
This study is enrolling now at Huangshan City, Anhui, China; Wuhu, Anhui, China; Beijing, Beijing Municipality, China; Zhanjiang, Guangdong, China; Changsha, Hunan, China; Changchun, Jilin, China and 3 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.