NCT05016323CompletedPhase 2
A Study to Evaluate the Efficacy and Safety of HR19042 Capsules in the Treatment of Primary IgA Nephropathy.
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.
Source: ClinicalTrials.gov · Last updated 12 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 316 (actual)
- First submitted
- 17 Aug 2021
- Start date
- 9 Sept 2021
- Primary completion date
- 9 Jun 2024
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Diseases
- IgA nephropathy
- NCT number
- NCT05016323
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 316
- From 9 Sept 2021 to the primary completion date, 9 Jun 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with severe chronic infection or active infection under systemic antibiotic therapy in previous 14 days；
- Patients received organ transplantation；
- 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.
Other illness
- Systemic diseases which could lead to secondary IgA nephropathy；
- Patients with severe cardiovascular diseases；
- Patients diagnosed with malignancy within the past 5 years；
- Patients with uncontrolled Type 1 or 2 diabetes；
- Positive results in HIV-Ab/TP-Ab/ HBsAg/HCV-Ab tests；
Other
- Patients with liver cirrhosis；
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nanfang Hospital of Southern Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.