A Study to Evaluate the Efficacy and Safety of HR19042 Capsules in the Treatment of Primary IgA Nephropathy.

Study Overview
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Brief Summary
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This study will evaluate the efficacy and safety of HR19042 capsules compared to matching placebo for the treatment of primary IgA nephropathy, and explore the optimal dose for the treatment.

Official Title
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A Randomized, Double-blind, Multicenter, Placebo-controlled, Parallel Groups, Phase II Clinical Trial to Evaluate the Efficacy and Safety of HR19042 Capsules in the Treatment of Primary IgA Nephropathy.

Conditions
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IgA Nephropathy

Intervention / Treatment
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* Drug: HR19042 Capsules
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female or male patients ≥18 years old； Biopsy-confirmed primary IgA nephropathy； Urine protein≥0.75 g/24hr or urine protein creatinine ratio (UPCR)≥0.5 g/g； Estimated GFR (using the CKD-EPI2009 formula) ≥30mL/min/1.73 m2； Willing and able to take adequate contraception during the trial; Willing and able to give informed consent and follow the protocols during the trial. Exclusion Criteria: Systemic diseases which could lead to secondary IgA nephropathy； Patients with severe chronic infection or active infection under systemic antibiotic therapy in previous 14 days； Patients with severe cardiovascular diseases； Patients diagnosed with malignancy within the past 5 years； Patients with liver cirrhosis； Patients received organ transplantation； Patients with uncontrolled Type 1 or 2 diabetes； Positive results in HIV-Ab/TP-Ab/ HBsAg/HCV-Ab tests； Patients treated with any systemic immunosuppressive drugs (excluding corticosteroids) within the past 12 months before screening； Patients treated with any systemic corticosteroids within the past 3 months before screening.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A randomized, double-blind, multicenter, placebo-controlled, parallel groups, Phase II clinical trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HR19042 Capsules<br> | Drug: HR19042 Capsules<br>* HR19042 Capsules<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in urine protein creatinine ratio (UPCR) |  | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in 24-hour proteinuria |  | 9 months | 
| Change from baseline in urine albumin creatinine ratio (UACR) |  | 9 months | 
| Change from baseline in estimated GFR |  | 9 months | 
| Change from baseline in estimated GFR |  | 12 months |