A Trial to Evaluate the Long-term Safety and Tolerability... | NCT07582133

Studies
A Trial to Evaluate the Long-term Safety and Tolerability of HRS-5965 in Patients With Primary IgA Nephropathy

NCT07582133

Sponsor

Chengdu Suncadia Medicine Co., Ltd.

Status

Not yet recruiting

Last Update Posted

May 12, 2026Actual

Enrollment

380Estimated

Phase

Phase 2

Conditions

Primary IgA Nephropathy

Interventions

HRS-5965 Capsules

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

May 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2026Estimated

Primary Completion Date

Jul 2029Estimated

Completion Date

Nov 2029Estimated

First Submitted Date

May 6, 2026

First Submission Date that Met QC Criteria

May 6, 2026

First Posted Date

May 12, 2026Actual

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

May 6, 2026

Last Update Posted Date

May 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 aims to evaluate the long-term safety of HRS-5965 capsules in patients with primary IgA nephropathy, and also to assess its efficacy in reducing 24-hour urinary protein and delaying the decline in eGFR in these patients.

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

380Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HRS-5965 Capsules	Experimental		Drug: HRS-5965 Capsules

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HRS-5965 Capsules	Drug	HRS-5965 Capsules	HRS-5965 Capsules

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The incidence and severity of adverse events (AEs) throughout the study;		2 years

Secondary Outcomes

Measure	Description	Time Frame
Ratio of 24-hour urine protein excretion (24-UPE) to baseline;		2 years
The change from baseline in estimated glomerular filtration rate (eGFR);		2 years
The change from baseline in serum creatinine (Scr);

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with primary IgA nephropathy who completed treatment in Study HRS-5965-305, or who prematurely discontinued study drug during the maintenance phase following initiation of rescue therapy;
Understand the research procedures and methods, voluntarily participate in this trial and sign the informed consent form in person.

Exclusion Criteria:

Hypersensitivity to the study drug or its components；
History of immunodeficiency disorders；
History of invasive encapsulated bacterial infection；
History of malignant neoplasm；
The estimated glomerular filtration rate (eGFR) is less than 20 mL/min/1.73m2；

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

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yanfang Zou	Contact	+0518-82342973		yanfang.zou@hengrui.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking University First Hospital		Beijing	Beijing Municipality	100000	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005922	Glomerulonephritis, IGA

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided