Active — Not RecruitingPhase 2

A Trial of HRS-5965 Tablets in Primary IgA Nephropathy

China123 participantsStarted 2023-12-19

Plain-language summary

The study is being conducted to evaluate the efficacy, and safety of HRS-5965 tablets for primary IgA nephropathy. To explore the effective dosage of HRS-5965 tablets for primary IgA nephropathy.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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 5 years;
✓. 24-UPE≥ 0.75g /24h, or UPCR≥ 0.8g/g at screening and prior to randomization;
✓. eGFR≥30 ml/min/1.73m2 at screening and prior to randomization; (CKD-EPI formula)
✓. 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);
✓. Receiving optimal supportive therapy including RAS blockers for 12 weeks and stabilizing the dose for at least 4 weeks after reaching the maximum recommended dose or the maximum tolerated dose prior to randomization;

Exclusion criteria

✕. 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;
✕. Have any organ transplant;
✕. Patients with chronic recurrent infections 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;
✕. Patients with a history of malignant neoplasms;
✕. 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;

What they're measuring

Ratio of 24-hour Urinary protein to creatinine ratio (UPCR) to baseline

Timeframe: Baseline and Week 12

Trial details

NCT IDNCT06137768

SponsorChengdu Suncadia Medicine Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-12-01

View on ClinicalTrials.gov More Primary IgA Nephropathy trials