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.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05016323

Enrollment

316

Registered

2021-08-23

Start date

2021-09-09

Completion date

2025-08-15

Last updated

2026-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IgA Nephropathy

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.

Interventions

DRUGHR19042 Capsules

HR19042 Capsules

DRUGPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

A randomized, double-blind, multicenter, placebo-controlled, parallel groups, Phase II clinical trial

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Change from baseline in urine protein creatinine ratio (UPCR)	9 months

Secondary

Measure	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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026