A Study to Evaluate the Efficacy and Safety of HR19042 Ca... | NCT05016323

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

NCT05016323

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Status

Completed

Last Update Posted

Mar 12, 2026Actual

Enrollment

316Actual

Phase

Phase 2

Conditions

IgA Nephropathy

Interventions

HR19042 Capsules
Placebo

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 9, 2021Actual

Primary Completion Date

Jun 9, 2024Actual

Completion Date

Aug 15, 2025Actual

First Submitted Date

Aug 17, 2021

First Submission Date that Met QC Criteria

Aug 17, 2021

First Posted Date

Aug 23, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 11, 2026

Last Update Posted Date

Mar 12, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

316Actual

Label	Type	Description	Intervention Names
HR19042 Capsules	Experimental		Drug: HR19042 Capsules
Placebo	Placebo Comparator		Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
HR19042 Capsules	Drug	HR19042 Capsules	HR19042 Capsules
Placebo

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
NanFang Hospital of Southern Medical University		Guangzhou	Guangdong	510515	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38299639	Derived	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.

ID	Term
D005921	Glomerulonephritis
D009393	Nephritis
D007674	Kidney Diseases
D014570	Urologic Diseases