IgA Nephropathy (IgAN)
Conditions
Keywords
kidney disease, Primary glomerular disease
Brief summary
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
MY008211A BID
Matching placebo to MY008211A taken twice a day.
Sponsors
Wuhan Createrna Science and Technology Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
The trial was a double-blind design.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The ratio of urine protein to creatinine concentration ratio (UPCR based on 24h urine collection, 24h-UPCR) relative to baseline at Week 12. | Week 12 | Participants collected their urine over a 24-hour period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The ratio of 24-hour urine protein excretion (24 h-UPE) relative to baseline at each visit during treatment period. | up to 24 weeks | Participants collected all of their urine over a 24-hour period. |
| The ratio of 24-hour urine albumin (24 h-UA) relative to baseline at each visit during treatment period. | up to 24 weeks | Participants collected all of their urine over a 24-hour period. |
| The ratio of 24 h-UPCR relative to baseline at each visit during treatment period except Week 12. | up to 24 weeks | Participants collected their urine over a 24-hour period. |
| Change from baseline in serum creatinine at each visit during treatment period. | up to 24 weeks | Serum creatinine |
| Change from baseline in estimated glomerular filtration rate (eGFR) at each visit during treatment period. | up to 24 weeks | eGFR was calculated according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI). |
| The ratio of 24-hour urine albumin to creatinine concentration ratio (24 h-UACR) relative to baseline at each visit during treatment period. | up to 24 weeks | Participants collected all of their urine over a 24-hour period. |
Countries
China
Contacts
Primary ContactDonghui Li, PH.D.
Outcome results
None listed