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: PlaceboDrug: 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 210
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.
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 urine albumin creatinine ratio (UACR) 9 months Change from baseline in estimated GFR 12 months Change from baseline in 24-hour proteinuria 9 months
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms does HR19042 target in IgA Nephropathy treatment?
How does HR19042 compare to standard-of-care therapies for IgA Nephropathy?
Which biomarkers are used for patient selection in NCT05016323 IgA Nephropathy trial?
What adverse events are associated with HR19042 in phase II IgA Nephropathy studies?
Are there combination therapies involving HR19042 for IgA Nephropathy under investigation?
Trial Locations
- Locations (1)
NanFang Hospital of Southern Medical University
🇨🇳Guangzhou, Guangdong, China
NanFang Hospital of Southern Medical University🇨🇳Guangzhou, Guangdong, ChinaFanfan Hou, DoctorContact