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Efficacy and Safety Study of HS-10542 for IgA Nephropathy

ConditionsIgANImmunoglobulin A Nephropathy (IgAN)Glomerular Disease
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-74
SponsorJiangsu Hansoh Pharmaceutical Co., Ltd.

About this trial

This is a multicenter, randomized, double-blind, parallel, placebo-controlled study and is being conducted to evaluate the efficacy and safety of HS-10542 capsules for primary IgA nephropathy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participant is a male or female≥18 years and≤74 years of age at the time of signing the informed consent.

Body weight≥35kg, BMI<37.5kg/m2.

Primary IgA nephropathy was confirmed by renal biopsy within 8 years.

24-hour urine protein excretion≥1.0g/24h, or UPCR≥0.8g/g at screening and prior to randomization.

Disqualifiers

Participants with a history of severe allergies to drugs, food or the environment, or allergic to any RAS blockers, investigational products, or components as evaluated by the investigator;

Participant has secondary forms of IgAN as defined by investigator (eg, IgA vasculitis nephritis, SLE) or participant has nephrotic syndrome (defined as proteinuria>3.5 g/day and serum albumin<3.0 g/dL, with or without edema);

IgA nephropathy with rapid decline of renal function; Kidney pathology indicated that more than 50% of the glomerulus had large crescent body formation, which may affect the study results; Tubule atrophy - interstitial fibrosis of more than 50%;

Patients with concomitant immunodeficiency disorders; or those with other systemic diseases assessed by the investigator as potentially causing proteinuria (e.g., diabetic nephropathy, autoimmune diseases, ANCA-associated vasculitis, etc.);

Trial design

Design model

Parallel

Treatments tested in this trial

  • HS-10542 High Dose

    Drug

    Drug: HS-10542 High Dose, QD

  • HS-10542 Low Dose

    Drug

    Drug: HS-10542 Low Dose, QD

  • Placebo

    Drug

    Placebo, QD

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: HS-10542 High Dose ArmExperimental treatment 1 intervention
Group B: HS-10542 Low Dose ArmExperimental treatment 1 intervention
Group C: Placebo ArmPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

The change of UPCR from baseline

Time frame
Baseline and Week 12

Secondary outcomes

1

Incidence and severity of adverse events of HS-10542 at each dosing

Time frame
Baseline to End of Study (week 24)
2

Changes from baseline in blood pressures

Blood pressure measured during vital sign assessments

Time frame
Baseline to End of Study (week 24)
3

Changes from baseline in heart rate

Heart rate measured during vital sign assessments

Time frame
Baseline to End of Study (week 24)
4

Changes from baseline in body temperature

Body temperature measured during vital sign assessments.

Time frame
Baseline to End of Study (week 24)

Other outcomes

Sponsors and contacts

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

Jiangsu Hansoh Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: