Clinical trial NCT06687174: Study to Evaluate the Efficacy and Safety of MY008211A in Subjects with Primary Immunoglobulin a Nephropathy (IgAN)
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)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: IgA Nephropathy (IgAN)
Keywords: kidney disease
Primary glomerular disease
Lead sponsor: Wuhan Createrna Science and Technology Co., Ltd
Sponsor class: INDUSTRY
First posted: 2024-11-13
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The ratio of urine protein to creatinine concentration ratio (UPCR based on 24h urine collection, 24h-UPCR) relative to baseline at Week 12.
timeFrame: Week 12
Secondary outcomes:
measure: The ratio of 24 h-UPCR relative to baseline at each visit during treatment period except Week 12.
timeFrame: up to 24 weeks
measure: The ratio of 24-hour urine protein excretion (24 h-UPE) relative to baseline at each visit during treatment period.
timeFrame: up to 24 weeks
measure: The ratio of 24-hour urine albumin (24 h-UA) relative to baseline at each visit during treatment period.
timeFrame: up to 24 weeks
measure: The ratio of 24-hour urine albumin to creatinine concentration ratio (24 h-UACR) relative to baseline at each visit during treatment period.
timeFrame: up to 24 weeks
measure: Change from baseline in serum creatinine at each visit during treatment period.
timeFrame: up to 24 weeks
measure: Change from baseline in estimated glomerular filtration rate (eGFR) at each visit during treatment period.
timeFrame: up to 24 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
Study officials:
affiliation: Peking University First Hospital
name: Hong Zhang, PH.D.
role: PRINCIPAL_INVESTIGATOR
References: