A Trial of HRS-5965 Capsule in Primary IgA Nephropathy

Launched by CHENGDU SUNCADIA MEDICINE CO., LTD. · Jun 3, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating a new medication called HRS-5965 in patients with a condition known as primary IgA nephropathy, which affects the kidneys. The study will compare HRS-5965 to a placebo (a pill with no active ingredients) to see if it is effective and safe. It is a phase 3 trial, meaning it is one of the final testing stages before the medication can be considered for approval. The trial is set to start recruiting participants soon and is open to individuals aged 65 and older, regardless of gender.

To be eligible for this study, participants must have a confirmed diagnosis of primary IgA nephropathy and meet certain health criteria, including specific kidney function measurements. They should also be able to provide informed consent, meaning they understand the study and agree to participate. During the trial, participants will receive either the HRS-5965 capsules or a placebo for a set period. Regular check-ups will monitor their health and response to the treatment. It's important for potential participants to know that there are specific health conditions that could exclude them from joining, such as certain other kidney diseases or serious infections. Overall, this trial aims to find out if HRS-5965 can help improve kidney health in patients with this condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Able and willing to provide a written informed consent；
• • 2. Weight ≥35 kg, Body mass index (BMI) \< 37.5kg /m2;
• • 3. Primary IgA nephropathy was confirmed by renal biopsy within 8 years;
• • 4. 24-UPE≥ 1.0g /24h, or 24-UPCR≥ 0.8g/g at screen, and 24-UPCR≥ 0.8g/g prior to randomization;
• • 5. eGFR≥30 ml/min/1.73m2 at screening and prior to randomization; (CKD-EPI formula)
• • 6. A fertile female subject or a male subject whose partner is a fertile female, who has not had a fertility, sperm/egg donation plan from the signing of the informed consent to 1 month after the last dose, and voluntarily takes effective contraceptive measures (including the partner);
• • 7. Understand the research procedures and methods, voluntarily participate in this trial, and sign the informed consent form in person.
• • 8. Receiving optimal supportive therapy including RAS blockers and stabilizing the dose for at least 12 weeks after reaching the maximum recommended dose or the maximum tolerated dose prior to randomization;
• Exclusion Criteria:
• • 1. Allergic to any RAS blockers, investigational products, or components as evaluated by the investigator;
• • 2. Patients with secondary IgA nephropathy as determined by the investigator;
• • 3. 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%;
• • 4. Patients with a history of immunodeficiency disease; Or in combination with other systemic diseases likely to cause proteinuria; Or with Nephrotic Syndrome;
• • 5. Have any organ transplant;
• • 6. Patients with active infection of tuberculosis within 1 year prior to screening, such as liver abscess and pyelonephritis; Or subjects with active infection who requiring intravenous antibiotic therapy within 2 weeks prior to randomization;
• • 7. Patients with a history of malignant neoplasms;
• • 8. Patients with a history of severe trauma or major surgery within 12 weeks prior to screening, or who plan to undergo surgery during the study period;
• • 9. Patients with a history of blood donation or a history of severe blood loss (≥400 mL blood loss) within 12 weeks prior to screening, or who have received blood transfusions within 12 weeks prior to screening;
• • 10. The presence of a disease or medical condition determined by the investigator might affect drug absorption, distribution, metabolism, and excretion;
• • 11. As determined by the investigator, the subject has any of the following: progression or recovery of a disease;
• • 12. Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), or total bilirubin exceeding 3 times the upper limit of normal (ULN) at screening;
• • 13. Participants who have participated in a clinical trial of any drug or medical device within 12 weeks prior to randomization and are expected to have residual effects of the investigational treatment (as determined by the investigator), or who were within the follow-up period of a clinical study, or within 5 half-lives of the investigational drug, or within 30 days (whichever is older) before screening;
• • 14. Women who are pregnant or breastfeeding;
• • 15. A history of drug abuse;
• • 16. Participants who received systemic glucocorticoid or immune suppressants within 12 weeks prior to randomization and are expected to have during research；
• • 17. Participants who received biologics or cytokine inhibitor within 6 months prior to randomization and are expected to have during research；
• • 18. Any physical or mental illness or condition that, as determined by the investigator, is likely to increase the risk of the study, affect the subject's adherence to the protocol, or prevent the subject from completing the study.