Recruiting

HRS-5965 Capsule for Primary IgA Nephropathy

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What is being tested

HRS-5965

+ Placebo

Drug
Who is being recruted

Urogenital Diseases+8

+ Autoimmune Diseases

+ Female Urogenital Diseases and Pregnancy Complications

Over 18 Years
+26 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 3
Interventional
Study Start: June 2025
See protocol details

Summary

Principal SponsorChengdu Suncadia Medicine Co., Ltd.
Study ContactSheng Qi
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 4, 2025

Actual date on which the first participant was enrolled.

This clinical trial is designed to assess how effective and safe a new medication called HRS-5965 is for people with a kidney disease known as primary IgA nephropathy. This condition occurs when a protein called IgA builds up in the kidneys, leading to inflammation and potential kidney damage. The study aims to see if HRS-5965 can help improve kidney function and reduce the symptoms of this disease. By participating, individuals could contribute to advancements in treatment options for those suffering from this challenging condition. Participants in the study will be randomly assigned to receive either the HRS-5965 capsule or a placebo, which is an inactive substance, to compare the results. The study is carefully designed to ensure neither the participants nor the researchers know who is receiving the actual medication, maintaining objectivity. Researchers will monitor the participants closely to evaluate the medication’s effects on their kidney health and any side effects that may occur. This process helps to ensure the treatment’s efficacy and safety for future use.

Official TitleMulticenter, Randomized, Double-blind, Parallel, Placebo-controlled Phase III Clinical Trial, to Evaluate the Efficacy and Safety of HRS-5965 Capsule in Primary IgA Nephropathy
NCT07014826
Principal SponsorChengdu Suncadia Medicine Co., Ltd.
Study ContactSheng Qi
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

378 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesAutoimmune DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsGlomerulonephritisGlomerulonephritis, IGAImmune System DiseasesKidney DiseasesNephritisUrologic DiseasesFemale Urogenital DiseasesMale Urogenital Diseases

Criteria

8 inclusion criteria required to participate
Able and willing to provide a written informed consent；
Weight ≥35 kg, Body mass index (BMI) < 37.5kg /m2;
Primary IgA nephropathy was confirmed by renal biopsy within 8 years;
24-UPE≥ 1.0g /24h, or 24-UPCR≥ 0.8g/g at screen, and 24-UPCR≥ 0.8g/g prior to randomization;
Show More Criteria
18 exclusion criteria prevent from participating
Allergic to any RAS blockers, investigational products, or components as evaluated by the investigator;
Patients with secondary IgA nephropathy as determined by the investigator;
IgA nephropathy with rapid decline of renal function; Kidney pathology indicated that more than 50% of the glomerulus had large crescent body formation, which may affect the study results; Tubule atrophy - interstitial fibrosis of more than 50%;
Patients with a history of immunodeficiency disease; Or in combination with other systemic diseases likely to cause proteinuria; Or with Nephrotic Syndrome;
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
HRS-5965

Group II

Placebo
Placebo

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Peking University First Hospital

Beijing, ChinaOpen Peking University First Hospital in Google Maps
Recruiting
One Study Center
HRS-5965 Capsule for Primary IgA Nephropathy | PatLynk