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

NCT05016323 | Completed Phase 2

• 1 other identifier: HR19042-201
• Study Type: interventional
• Target: 316
• Locations: 1 country
• Sites: 1

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.

Conditions

IgA Nephropathy

Outcome Measures

Primary Outcomes (1)

• Change from baseline in urine protein creatinine ratio (UPCR)

  9 months

Secondary Outcomes (4)

• 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

• Change from baseline in estimated GFR

  12 months

Study Arms (2)

HR19042 Capsules

EXPERIMENTAL

Drug: HR19042 Capsules

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

HR19042 Capsules DRUG

HR19042 Capsules

HR19042 Capsules

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

NanFang Hospital of Southern Medical University

Guangzhou, Guangdong, 510515, China

Location

Related Publications (1)

• Tunnicliffe DJ, Reid S, Craig JC, Samuels JA, Molony DA, Strippoli GF. Non-immunosuppressive treatment for IgA nephropathy. Cochrane Database Syst Rev. 2024 Feb 1;2(2):CD003962. doi: 10.1002/14651858.CD003962.pub3.

  PMID: 38299639 DERIVED

MeSH Terms

Conditions

Glomerulonephritis, IGA

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: August 17, 2021
• First Posted: August 23, 2021
• Study Start: September 9, 2021
• Primary Completion: June 9, 2024
• Study Completion: August 15, 2025
• Last Updated: March 12, 2026

Record last verified: 2025-09

Locations

CN (1)