The purpose of this study is to evaluate the efficacy and safety of Telitacicept in patients with primary IgA nephropathy at risk of progressing to end-stage renal disease(ESRD), despite maximum tolerated treatment with renin-angiotensin system(RAS) blockade using angiotensin converting enzyme inhibitors (ACEIs) or angiotensin II type I receptor blockers (ARBs).
This study consists of a 5-week screening period, a double-blind treatment period divided into phase A and phase B. Eligible subjects will be randomly assigned in a 1:1 ratio to receive either Telitacicept 240mg or placebo. Subjects will be given subcutaneous injection(SC) Telitacicept or placebo once a week for a total of 39 doses in phase A and once every 2 weeks for a total of 32 doses in phase B. Primary endpoint of phase A will be measured at week 39. Primary endpoint of phase B will be measured at week 104.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
318
Subcutaneous injection
Placebo to Telitacicept
Change from baseline in urine protein creatinine ratio (UPCR)
Based on a 24-hour urine collections.
Time frame: 39 weeks
Annualized estimated glomerular filtration rate (eGFR) slope
eGFR is calculated using the CKD-EPI formula.
Time frame: 104 weeks
Proportion of patients with a 30% decrease in estimated glomerular filtration rate (eGFR) compared with baseline
eGFR is calculated using the CKD-EPI formula.
Time frame: 39 weeks
Time to 30% reduction from baseline in eGFR
eGFR is calculated using the CKD-EPI formula and confirmed by a second sample collection and calculation after at least 4 weeks.
Time frame: up to 104 weeks
Proportion of patients with a 40% decrease in estimated glomerular filtration rate (eGFR) compared with baseline
eGFR is calculated using the CKD-EPI formula and confirmed by a second sample collection and calculation after at least 4 weeks.
Time frame: up to 104 weeks
Proportion of patients received rescue treatment.
patients using systemic immunosuppressive medications, glucocorticoids (GCSs), etc.
Time frame: up to 104 weeks
Incidence and severity of adverse events
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
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The First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui, China
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
Hefei, Anhui, China
The Second Hospital of Anhui Medical University
Hefei, Anhui, China
The First Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, China
Beijing Anzhen Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, China
Beijing Hospital
Beijing, Beijing Municipality, China
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, China
Peking University First Hospital
Beijing, Beijing Municipality, China
Peking University People's Hospital
Beijing, Beijing Municipality, China
Peking University Shougang Hospital
Beijing, Beijing Municipality, China
...and 91 more locations
Time frame: up to 104 weeks
Change from baseline in urine protein creatinine ratio (UPCR)
Based on 24-hour urine collections.
Time frame: 52 weeks,78 weeks,104 weeks
Change from baseline in estimated glomerular filtration rate (eGFR)
eGFR is calculated using the CKD-EPI formula.
Time frame: 39 weeks, 52 weeks,78 weeks,104 weeks
Change from baseline in UACR in urine albumin-to-creatinine ratio (UACR)
Based on 24-hour urine collections.
Time frame: 39 weeks, 52 weeks,78 weeks,104 weeks
Time to composite endpoint event
The composite endpoint event is defined as initiation of maintenance renal dialysis (for at least 1 month), eGFR \<15 mL/min/1.73 m\^2, renal transplant, or death due to renal failure. eGFR is calculated using the CKD-EPI formula (CKD-EPI).
Time frame: up to 104 weeks
Proportion of patients achieving urine protein creatinine ratio (UPCR) < 0.8 g/g
UPCR is calculated based on 24-hour urine collections;
Time frame: 39 weeks, 52 weeks,78 weeks,104 weeks
Annualized estimated glomerular filtration rate (eGFR) slope
eGFR is calculated using the CKD-EPI formula.
Time frame: 52 weeks