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

Phase 2

• Conditions: IgA Nephropathy
• Interventions: Drug: Placebo; Drug: HR19042 Capsules

• Registration Number: NCT05016323
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-08
• Study First Submitted: 2021-08-17
• Study First Submitted QC: 2021-08-17
• Study First Posted: 2021-08-23
• Study Start: 2021-09-09
• Last Update Submitted: 2021-10-11
• Last Update Posted: 2021-10-12
• Primary Completion: 2024-02-29
• Study Completion: 2024-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

1. Female or male patients ≥18 years old；
2. Biopsy-confirmed primary IgA nephropathy；
3. Urine protein≥0.75 g/24hr or urine protein creatinine ratio (UPCR)≥0.5 g/g；
4. Estimated GFR (using the CKD-EPI2009 formula) ≥30mL/min/1.73 m2；
5. Willing and able to take adequate contraception during the trial;
6. Willing and able to give informed consent and follow the protocols during the trial.

Exclusion Criteria

1. Systemic diseases which could lead to secondary IgA nephropathy；
2. Patients with severe chronic infection or active infection under systemic antibiotic therapy in previous 14 days；
3. Patients with severe cardiovascular diseases；
4. Patients diagnosed with malignancy within the past 5 years；
5. Patients with liver cirrhosis；
6. Patients received organ transplantation；
7. Patients with uncontrolled Type 1 or 2 diabetes；
8. Positive results in HIV-Ab/TP-Ab/ HBsAg/HCV-Ab tests；
9. Patients treated with any systemic immunosuppressive drugs (excluding corticosteroids) within the past 12 months before screening；
10. Patients treated with any systemic corticosteroids within the past 3 months before screening.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
HR19042 Capsules	HR19042 Capsules	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in urine protein creatinine ratio (UPCR)	9 months

Secondary Outcome Measures

Name	Time	Method
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	12 months

Trial Locations

Locations (1)

NanFang Hospital of Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China