Health TrialsbyHealthPanel

Phase Ⅲ Study of Efficacy and Safety of HSK39297 Tablet in Treatment of Patients With Primary IgAN

ConditionIgA Nephropathy (IgAN)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorHaisco Pharmaceutical Group Co., Ltd.

About this trial

Evaluate the efficacy and safety of HSK39297 tablets in patients with primary IgAN

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects must have signed and dated an IRB/IEC approved written informed consent form.Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, tumor biopsies, and other requirements of the study.

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

Subjects with a biopsy-verified IgA nephropathy and where the biopsy was performed within the prior ten years.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • HSK39297

    Drug

    HSK39297 200mg, once a day; treatment period; 48-weeks fixed dose.

  • Placebo

    Drug

    Placebo, once a day; treatment period; 48-weeks fixed dose.

Treatment groups

370 Participants
are divided into 2 treatment groups
Group A: PlaceboPlacebo comparator 1 intervention
Group B: HSK39297 200mgQDExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Ratio to baseline in Urine Protein to Creatinine Ratio (sampled from 24h urine collection) at 36 weeks

Time frame
From week 1 to week 36
2

Annualized total estimated Glomerular Filtration Rate slope over 48 weeks

Time frame
From week 1 to week 48

Secondary outcomes

1

Annualized total estimated Glomerular Filtration Rate slope over 36 weeks

Time frame
From week 1 to week 36
2

Annualized total estimated Glomerular Filtration Rate slope over 104 weeks

Time frame
From week 1 to week 104
3

Incidence , severity and relationship of adverse events during the study period

Time frame
From week 1 to week 108

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Haisco Pharmaceutical Group Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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