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NCT06687174 | NOT YET RECRUITING | IgA Nephropathy (IgAN)

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

Wuhan Createrna Science and Technology Co., Ltd

Brief Summary:

Efficacy and safety of MY008211A in IgAN patients

Condition or disease

Egy Neferbeth (perineum)

Intervention/treatment

MY008211A tablets

MY008211A tablets matched placebo

Phase

PHASE2

Detailed Description:

This was a multicenter, randomized, double-blind, dose-ranging, parallel-group study. Two doses of MY008211A (200mg, 400mg) were compared with placebo. The study comprised a screening period of this study for 90 days, an efficacy observation period for 24 weeks, a long-term study for 80 weeks, and a follow-up period for 2 weeks.

Study Type : INTERVENTIONAL
Estimated Enrollment : 72 participants
Masking : TRIPLE
Masking Description : The trial was a double-blind design.
Primary Purpose : TREATMENT
Official Title : A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Evaluate the Efficacy and Safety of MY008211A in Subjects with Primary Immunoglobulin a Nephropathy (IgAN)
Actual Study Start Date : 2024-12-31
Estimated Primary Completion Date : 2026-06-15
Estimated Study Completion Date : 2028-01-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
Study to Evaluate the Efficacy and Safety of MY008211A in Subjects with Primary Immunoglobulin a Nephropathy (IgAN)

Location Details

NCT06687174

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How to Participate

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Locations

Not yet recruiting

China, Beijing

Peking University First Hospital

Beijing, Beijing, China, 100034