Clinical trial NCT06635772: A Study of the Effect and Safety of HS-10390 in the Treatment of Patients with Primary IgA Nephropathy
Official title: A Randomized, Multicenter, Open-label, Active-control Study of the Efficacy and Safety of HS-10390 for the Treatment of Immunoglobulin a Nephropathy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Immunoglobulin a Nephropathy
Keywords: Immunoglobulin A Nephropathy
Lead sponsor: Hansoh BioMedical R&D Company
Sponsor class: INDUSTRY
First posted: 2024-10-10
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the efficacy and safety of HS-10390 in subjects with primary IgA nephropathy, and explore the optimal dose for the treatment.


Eligibility criteria: Inclusion Criteria:

* Male or female, between 18 and 65 years age.
* Biopsy-proven primary IgA nephropathy.
* Currently on stable dose of ACEI and/or ARB therapy, for at least 12 weeks prior to screening (the patient's maximum tolerated dose and is at least one-half of the maximum labeled dose).
* Average 24-hour urine total protein ≥ 0.75 g/24 h at screening.
* Estimated GFR (using the CKD-EPI 2009) ≥ 30 mL/min per 1.73 m\^2 at screening.
* Systolic BP between 100 and 150 mmHg and diastolic BP between 60 and 100 mmHg.

Exclusion Criteria:

* IgA nephropathy secondary to another condition
* 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%;
* Chronic kidney disease (CKD) in addition to IgAN
* Patients treated with any systemic non-biologic immunosuppressive drugs (including systemic corticosteroids) within 12 weeks prior to randomizing；
* Require any prohibited medications prior to randomizing;
* Exposure to an investigational drug within 30 days or 5 half-lives (whichever is longer) prior to screening
* History of organ transplantation, with exception of corneal transplants
* Platelet\< 100×109/L or hemoglobin value \< 90 g/L) or Hematocrit value \< 27% (0.27 V/V) at Screening
* Elevations of transaminases (ALT and/or AST) \>2 times upper limit of normal or total bilirubin and/or direct bilirubin exceeding 1.5 times the upper limit of normal (ULN) at screening
* Potassium \>5.5 mmol/L at Screening

Primary outcomes:
measure: Change from baseline in 24-hour urine protein at Week 12
timeFrame: up to week 12
Secondary outcomes:
measure: Change from baseline in 24-hour urine protein (UPCR)
timeFrame: up to Week 12
measure: Change from baseline in 24-hour urine protein(UACR)
timeFrame: up to Week 12
measure: Change from baseline in 24-hour urine protein
timeFrame: up to Week 12
measure: Proportion Change from baseline in 24-hour urine protein
timeFrame: up to Week 12
measure: change from baseline in Estimated Glomerular Filtration Rate
timeFrame: up to Week 12
measure: Number of subjects with adverse events (AEs)
timeFrame: up to Week 12
measure: Plasma Concentration of HS-10390
timeFrame: up to Week 12
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
Study officials:
References: