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Completed

NCT Number: NCT05016323

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

NanFang Hospital of Southern Medical University

Guangzhou, Guangdong, 510515, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HR19042 Capsules

Drug

HR19042 Capsules

Placebo

Drug

Placebo

Primary outcomes

  1. Change from baseline in urine protein creatinine ratio (UPCR)

    Time frame: 9 months

Secondary outcomes

  1. Change from baseline in 24-hour proteinuria

    Time frame: 9 months

  2. Change from baseline in urine albumin creatinine ratio (UACR)

    Time frame: 9 months

  3. Change from baseline in estimated GFR

    Time frame: 9 months

  4. Change from baseline in estimated GFR

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study title

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.

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Aug 23, 2021
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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