Study to Evaluate the Efficacy and Safety of MY008211A in Subjects with Primary Immunoglobulin a Nephropathy (IgAN)

Launched by WUHAN CREATERNA SCIENCE AND TECHNOLOGY CO., LTD · Nov 11, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called MY008211A for people with a kidney condition known as IgA Nephropathy (IgAN). The goal is to find out if this treatment is effective and safe for patients. The trial is not yet recruiting participants, but when it begins, it will include men and women aged 18 to 75 who have been diagnosed with IgAN through a kidney biopsy. To be eligible, participants must also have certain kidney function levels and have been on stable treatment for their condition for at least three months.

If you or a loved one qualifies and decides to participate, you can expect to be monitored closely throughout the trial to see how well the treatment works and if there are any side effects. It's important to note that there are specific health criteria that could exclude someone from joining, such as having high blood pressure or other serious kidney diseases. Also, participants will need to have certain vaccinations before starting the study. This trial aims to provide valuable information that could help improve treatment options for people with IgAN in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Males or females ≥ 18 and ≤ 75 years of age at Screening.
• • 2. Estimated GFR(eGFR) ≥30 mL/min/1.73m2.
• • 3. Subjects with a biopsy-confirmed diagnosis of IgAN.
• • 4. Urine protein ≥0.75 g/24h from a 24h urine collection.
• • 5. All patients must have been on stable supportive care including a maximally tolerated dose or approved maximal dose of ACEi or ARB therapy for at least 90 days prior to the first administration of study drug.
• • 6. Subjects who received SGLT2i must have been on a stable treatment with the maximum allowed or tolerated dose prior to the first administration of study drug.
• • 7. Vaccination against Neisseria meningitidis(MenACWY) is required within 3 years.
• • 8. Vaccination for the prevention of S. pneumoniae is required within 5 years.
• Exclusion Criteria:
• • 1. Systolic blood pressure \>130 mm Hg or diastolic blood pressure \>80 mm Hg.
• • 2. Presence of any secondary IgAN.
• • 3. Presence of rapidly progressive glomerulonephritis.
• • 4. Presence of other chronic kidney diseases.
• • 5. Patients with a diagnosis of type 1 or type 2 diabetes mellitus.
• • 6. A history of invasive infections caused by encapsulated bacteria, e.g., meningococci or pneumococci.
• • 7. Patients previously treated with immunosuppressive agents exposure within 90 days prior to start of study drug dosing.
• • 8. Patients previously treated with traditional Chinese medicine containing immunosuppressive ingredients within 90 days prior to start of study drug dosing.
• • 9. Patients who had been treated with any systemic corticosteroids within the 180 days before treatment ≥20 mg/d for primary IgAN indication.
• • 10. Patients who previously have received biologic agent or monoclonal antibodies prior to start of study drug dosing within 5 half-lives or 30 days (whichever is longer).
• • 11. Patients who have received live/attenuated vaccines within the 4 weeks prior to randomization, or plan to receive during the trial.