CompletedPhase 2

A Study to Evaluate the Efficacy and Safety of HR19042 Capsules in the Treatment of Primary IgA Nephropathy.

China316 participantsStarted 2021-09-09

Plain-language summary

This study will evaluate the efficacy and safety of HR19042 capsules compared to matching placebo for the treatment of primary IgA nephropathy, and explore the optimal dose for the treatment.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Female or male patients ≥18 years old；
✓. Biopsy-confirmed primary IgA nephropathy；
✓. Urine protein≥0.75 g/24hr or urine protein creatinine ratio (UPCR)≥0.5 g/g；
✓. Estimated GFR (using the CKD-EPI2009 formula) ≥30mL/min/1.73 m2；
✓. Willing and able to take adequate contraception during the trial;
✓. Willing and able to give informed consent and follow the protocols during the trial.

Exclusion criteria

✕. Systemic diseases which could lead to secondary IgA nephropathy；
✕. Patients with severe chronic infection or active infection under systemic antibiotic therapy in previous 14 days；
✕. Patients with severe cardiovascular diseases；
✕. Patients diagnosed with malignancy within the past 5 years；
✕. Patients with liver cirrhosis；
✕. Patients received organ transplantation；
✕. Patients with uncontrolled Type 1 or 2 diabetes；
✕. Positive results in HIV-Ab/TP-Ab/ HBsAg/HCV-Ab tests；

What they're measuring

Change from baseline in urine protein creatinine ratio (UPCR)

Timeframe: 9 months

Trial details

NCT IDNCT05016323

SponsorJiangsu HengRui Medicine Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-06-09

View on ClinicalTrials.gov More IgA Nephropathy trials