Testing MY008211A tablets for a kidney disease called IgA nephropathy
Tests MY008211A tablets against a placebo in adults with IgA nephropathy, a kidney disease.
Plain-language title generated from the registry record
Registry title: Study to Evaluate the Efficacy and Safety of MY008211A in Subjects with Primary Immunoglobulin a Nephropathy (IgAN)
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT06687174, who can take part
Where in China
- Peking University First HospitalBeijing, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Wuhan Createrna Science and Technology Co., Ltd
- Trial code
- NCT06687174
- Record updated
- 18 November 2024
- Original description
Efficacy and safety of MY008211A in IgAN patientsRead full original descriptionShow less
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)
Efficacy and safety of MY008211A in IgAN patients
Inclusion: Males or females ≥ 18 and ≤ 75 years of age at Screening; Estimated GFR(eGFR) ≥30 mL/min/1.73m2; Subjects with a biopsy-confirmed diagnosis of IgAN; Urine protein ≥0.75 g/24h from a 24h urine collection; 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; 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; Vaccination against Neisseria meningitidis(MenACWY) is required within 3 years; Vaccination for the prevention of S. pneumoniae is required within 5 years.
Exclusion: Patients previously treated with immunosuppressive agents exposure within 90 days prior to start of study drug dosing; Patients previously treated with traditional Chinese medicine containing immunosuppressive ingredients within 90 days prior to start of study drug dosing; Patients who had been treated with any systemic corticosteroids within the 180 days before treatment ≥20 mg/d for primary IgAN indication; 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); Patients who have received live/attenuated vaccines within the 4 weeks prior to randomization, or plan to receive during the trial; Presence of other chronic kidney diseases; Patients with a diagnosis of type 1 or type 2 diabetes mellitus; A history of invasive infections caused by encapsulated bacteria, e.g., meningococci or pneumococci; Systolic blood pressure >130 mm Hg or diastolic blood pressure >80 mm Hg; Presence of any secondary IgAN; Presence of rapidly progressive glomerulonephritis.