NCT07582133

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
380

participants targeted

Target at P75+ for phase_2

Timeline
42mo left

Started May 2026

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress2%
May 2026Nov 2029

Study Start

First participant enrolled

May 1, 2026

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

May 6, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 12, 2026

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2029

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2029

Last Updated

May 12, 2026

Status Verified

May 1, 2026

Enrollment Period

3.2 years

First QC Date

May 6, 2026

Last Update Submit

May 6, 2026

Conditions

Primary IgA Nephropathy

Outcome Measures

Primary Outcomes (1)

  • The incidence and severity of adverse events (AEs) throughout the study;

    2 years

Secondary Outcomes (5)

  • 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);

    2 years

  • The proportion of participants with 24-UPE < 0.5 g/d;

    2 years

  • The proportion of participants with 24-UPE < 0.3 g/d;

    2 years

Study Arms (1)

HRS-5965 Capsules

EXPERIMENTAL
Drug: HRS-5965 Capsules

Interventions

HRS-5965 CapsulesDRUG

HRS-5965 Capsules

HRS-5965 Capsules

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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；

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100000, China

Location

MeSH Terms

Conditions

Glomerulonephritis, IGA

Condition Hierarchy (Ancestors)

GlomerulonephritisNephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesAutoimmune DiseasesImmune System Diseases

Central Study Contacts

Yanfang Zou

CONTACT

+0518-82342973yanfang.zou@hengrui.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2026

First Posted

May 12, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

July 1, 2029

Study Completion (Estimated)

November 1, 2029

Last Updated

May 12, 2026

Record last verified: 2026-05

Locations

CN(1)