A Study of Telitacicept in Patients With Primary IgA Nephropathy
- Conditions
- Primary IgA Nephropathy
- Interventions
- Drug: Placebo
- Registration Number
- NCT05799287
- Lead Sponsor
- RemeGen Co., Ltd.
- Brief Summary
The purpose of this study is to evaluate the efficacy and safety of Telitacicept in patients with primary IgA nephropathy.
- Detailed Description
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 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 308
- Voluntary informed consent provided;
- Male or female aged ≥ 18 years old;
- IgA nephropathy confirmed by pathological biopsy;
- During the screening period, UPCR ≥ 0.5 g/g based on 24-hour urine collection at visit 1 and/or visit 2 and at visit 3;
- eGFR ≥ 30 mL/min per 1.73 m^2 (using the CKD-EPI);
- Have been on a treatment regimen including ACEI/ARB for 12 weeks and on a stable use of ACEI/ARB medication at the maximum tolerated dose/maximum allowable dose within 4 weeks prior to randomization. Subjects who use both ACEIs and ARBs will be excluded.
- Subjects with clinically significant abnormal laboratory tests;
- Patients with secondary IgA nephropathy;
- Patients with other types of glomerular disease such as crescentic glomerulonephritis, minimal change nephropathy with IgA deposition;
- Renal transplant;
- Patients with cirrhosis, as assessed by the investigator;
- Patients who experienced any of the following cardiovascular and cerebrovascular events within 24 weeks prior to randomization: myocardial infarction, unstable angina, ventricular arrhythmia, NYHA Class II or higher heart failure, stroke, etc.;
- Sitting office SBP>140 mmHg or DBP>90 mmHg during the screening period;
- HbA1c>8% (64mmol/mol);
- Treatment with immunosuppressants (cyclophosphamide, azathioprine, mycophenolate, leflunomide, tacrolimus, cyclosporine, Tripterygium wilfordii, etc.) within 12 weeks prior to randomization;
- Treatment with anti-CD20 therapy within 24 weeks prior to randomization;
- Treatment with systemic glucocorticoid within 12 weeks prior to randomization;
- Hospitalization or intravenous anti-infective therapy for active infection within 4 weeks prior to randomization;
- Patients with active tuberculosis and untreated latent tuberculosis;
- Hepatitis B: patients with active hepatitis (patients with positive HBsAg) or latent hepatitis B (patients with positive HBcAb and positive HBV-DNA);
- Patients with hepatitis C;
- Patients with HIV;
- Patients with malignancy within the past 5 years, except for treated cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, colon polyps, or cervical cancer in situ;
- Pregnant women, lactating women, and subjects with childbearing plans during the trial;
- Unavoidable use of drugs with renal toxicity during the study;
- Allergic to biological products of human origin;
- Patients who have received any investigational therapy within 4 weeks or within 5 times the half-life of the investigational product (whichever is longer) prior to randomization;
- Live vaccination within 4 weeks prior to randomization;
- Patients with COVID-19 infection within 4 weeks of randomization or patients with a history of serious COVID-19 disease requiring hospitalization within 52 weeks prior to screening;
- Drug or alcohol abuse/dependence within 52 weeks prior to randomization;
- Not suitable for the study in the opinion of the investigator.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Telitacicept Telitacicept Subjects will be given Telitacicept 240 mg SC once a week in phase A for a total of 39 doses and once every 2 weeks in phase B for a total of 32 doses. Placebo Placebo Subjects will be given placebo SC once a week in phase A for a total of 39 doses and once every 2 weeks in phase B for a total of 32 doses.
- Primary Outcome Measures
Name Time Method Change from baseline in urine protein creatinine ratio (UPCR) 39 weeks Based on a 24-hour urine collections.
Annualized estimated glomerular filtration rate (eGFR) slope 104 weeks eGFR is calculated using the CKD-EPI formula.
- Secondary Outcome Measures
Name Time Method Proportion of patients with a 30% decrease in estimated glomerular filtration rate (eGFR) compared with baseline 39 weeks eGFR is calculated using the CKD-EPI formula.
Time to 30% reduction from baseline in eGFR up to 104 weeks eGFR is calculated using the CKD-EPI formula and confirmed by a second sample collection and calculation after at least 4 weeks.
Proportion of patients with a 40% decrease in estimated glomerular filtration rate (eGFR) compared with baseline up to 104 weeks eGFR is calculated using the CKD-EPI formula and confirmed by a second sample collection and calculation after at least 4 weeks.
Proportion of patients received rescue treatment. up to 104 weeks patients using systemic immunosuppressive medications, glucocorticoids (GCSs), etc.
Incidence and severity of adverse events up to 104 weeks 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.
Change from baseline in urine protein creatinine ratio (UPCR) 52 weeks,78 weeks,104 weeks Based on 24-hour urine collections.
Change from baseline in estimated glomerular filtration rate (eGFR) 39 weeks, 52 weeks,78 weeks,104 weeks eGFR is calculated using the CKD-EPI formula.
Change from baseline in UACR in urine albumin-to-creatinine ratio (UACR) 39 weeks, 52 weeks,78 weeks,104 weeks Based on 24-hour urine collections.
Time to composite endpoint event up to 104 weeks 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).
Proportion of patients achieving urine protein creatinine ratio (UPCR) < 0.8 g/g 39 weeks, 52 weeks,78 weeks,104 weeks UPCR is calculated based on 24-hour urine collections;
Annualized estimated glomerular filtration rate (eGFR) slope 52 weeks eGFR is calculated using the CKD-EPI formula.
Trial Locations
- Locations (101)
The First Affiliated Hospital of Bengbu Medical College
🇨🇳Bengbu, Anhui, China
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
🇨🇳Hefei, Anhui, China
The Second Affiliated Hospital of Anhui Medical University
🇨🇳Hefei, Anhui, China
Yijishan Hospital of Wannan Medical College
🇨🇳Wuhu, Anhui, China
Beijing Anzhen Hospital Affiliated to Capital Medical University
🇨🇳Beijing, Beijing, China
Beijing Hospital
🇨🇳Beijing, Beijing, China
Beijing Tsinghua Changgeng Hospital
🇨🇳Beijing, Beijing, China
Peking University First Hospital
🇨🇳Beijing, Beijing, China
Peking University People's Hospital
🇨🇳Beijing, Beijing, China
Peking University Shougang Hospital
🇨🇳Beijing, Beijing, China
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