Not yet recruiting NCT06687174
Study to Evaluate the Efficacy and Safety of MY008211A in Subjects with Primary Immunoglobulin a Nephropathy (IgAN)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MY008211A tablets, MY008211A tablets matched placebo.
- Who it may be relevant to
- Registry conditions: IgA Nephropathy (IgAN). Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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)
Overview
Efficacy and safety of MY008211A in IgAN patients
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.
Interventions
- Drug MY008211A tablets
MY008211A BID - Drug MY008211A tablets matched placebo
Matching placebo to MY008211A taken twice a day.
Primary outcome measures
- The ratio of urine protein to creatinine concentration ratio (UPCR based on 24h urine collection, 24h-UPCR) relative to baseline at Week 12. [Time frame: Week 12]
Secondary outcome measures (6)
- The ratio of 24 h-UPCR relative to baseline at each visit during treatment period except Week 12. [Time frame: up to 24 weeks]
- The ratio of 24-hour urine protein excretion (24 h-UPE) relative to baseline at each visit during treatment period. [Time frame: up to 24 weeks]
- The ratio of 24-hour urine albumin (24 h-UA) relative to baseline at each visit during treatment period. [Time frame: up to 24 weeks]
- The ratio of 24-hour urine albumin to creatinine concentration ratio (24 h-UACR) relative to baseline at each visit during treatment period. [Time frame: up to 24 weeks]
- Change from baseline in serum creatinine at each visit during treatment period. [Time frame: up to 24 weeks]
- Change from baseline in estimated glomerular filtration rate (eGFR) at each visit during treatment period. [Time frame: up to 24 weeks]
Eligibility criteria
Inclusion criteria
- 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 criteria
- Systolic blood pressure >130 mm Hg or diastolic blood pressure >80 mm Hg.
- Presence of any secondary IgAN.
- Presence of rapidly progressive glomerulonephritis.
- 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.
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Peking University First Hospital — Beijing
Identifiers
NCT: NCT06687174 · MY008211A-IgAN-2-01