Actively Recruiting
A Study to Evaluate the Efficacy, Safety, and Tolerability of Human Sialidase Fusion Protein (HLX79) in Combination With Rituximab Injection Versus Placebo in Patients With Active Glomerulonephritis
Led by Shanghai Henlius Biotech · Updated on 2025-11-18
24
Participants Needed
17
Research Sites
247 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The primary objectives of this clinical trial is to evaluate the safety and tolerability of HLX79 in combination with HLX01 versus placebo in combination with HLX01 in the treatment of glomerulonephritis. The secondary objective are to evaluate the pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of HLX79 and HLX01, the clinical efficacy, the dynamic changes of biomarkers of HLX79 in combination with HLX01 in the treatment of glomerulonephritis. The subjects will receive different doses of HLX79 (10, 20, or 30 mg/kg) or placebo, all in combination with HLX01. After the end of the first treatment period, subjects will enter a 20-week follow-up period and then undergo pre-second treatment period assessments. If the investigator determines that the subject does not require the second treatment period, the subject will continue in follow-up until completing the total 48-week follow-up period.
CONDITIONS
Official Title
A Study to Evaluate the Efficacy, Safety, and Tolerability of Human Sialidase Fusion Protein (HLX79) in Combination With Rituximab Injection Versus Placebo in Patients With Active Glomerulonephritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients who agree to participate, understand the study, and can complete all procedures
- Male or female aged 18 to 75 years
- Diagnosed with primary membranous nephropathy within 5 years prior to screening
- Confirmed primary MN diagnosis by renal biopsy or positive anti-PLA2R antibody test within 6 months
- Exclusion of secondary membranous nephropathy causes
- Received ACEI/ARB treatment at highest tolerated dose for 3 months prior to screening (unless intolerant)
- Meet one high-risk criterion: urine protein >8 g/24 h at screening or eGFR ≥ 60 mL/min/1.73 m2 with urine protein >3.5 g/24 h
- Women of childbearing potential must have negative pregnancy test at screening
- Agree to use effective contraception from signing consent until 12 months after last dose
You will not qualify if you...
- Pregnant or breastfeeding women or positive pregnancy test prior to randomization
- Women or partners planning pregnancy during the study
- History of drug or alcohol abuse within 1 year prior to screening
- History or risk of malignancy except certain treated skin or cervical cancers within 5 years
- History of organ, stem cell, or bone marrow transplantation
- Primary immunodeficiency or type 1 diabetes; type 2 diabetes with diabetic nephropathy excluded by biopsy
- Unstable or poorly controlled diseases including cardiovascular, hematological, respiratory, digestive, endocrine, nervous system, psychiatric, skin, musculoskeletal, immune disorders, or severe abnormal medical conditions
- End-stage renal disease requiring transplantation or dialysis, or urine output <400 mL/24 h
- Acute, recurrent, or chronic infections at screening
- Recent infections requiring hospitalization or intravenous/intramuscular anti-infective drugs within 2 months
- Lung imaging suggesting tuberculosis infection
- Abnormal ECG with prolonged QT interval
- Abnormal lab tests including low blood counts, liver enzyme elevations, low eGFR (<30), high INR, positive tests for certain infections (HIV, syphilis, hepatitis B or C), or interferon gamma release assay positive
- History of serious drug allergies or anaphylaxis to study drugs or related agents
- Recent or ongoing treatment with specified immunosuppressive or targeted drugs within defined timeframes
- Recent intravenous immunoglobulin or plasma exchange
- Participation in other clinical trials or surgical/device studies within specified periods
- Recent live or live attenuated vaccine use
- Use of certain herbal or traditional medicines within 14 days prior to randomization
- Poor venous access or unwillingness for repeated blood draws
- Recent significant blood donation or blood loss
- Investigator judgment that participation risks subject's rights or safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 17 locations
1
Beijing Tsinghua Changgung Hospital
Beijing, China
Not Yet Recruiting
2
Peking University People's Hospital
Beijing, China
Not Yet Recruiting
3
Xiangya Hospital Of Gentral South University
Changsha, China
Not Yet Recruiting
4
Guangdong Provincial People's Hospital
Guangzhou, China
Not Yet Recruiting
5
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, China
Not Yet Recruiting
6
The First Affiliated Hospital Zhejiang University School Of Medicine
Hangzhou, China
Not Yet Recruiting
7
The Second Hospital of Anhui Medical University
Hefei, China
Not Yet Recruiting
8
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, China
Not Yet Recruiting
9
Jiangxi Provincial People's Hospital
Nanchang, China
Not Yet Recruiting
10
The First Affiliated Hospital of Nanchang University
Nanchang, China
Not Yet Recruiting
11
Jiangsu Province Hospital
Nanjing, China
Not Yet Recruiting
12
Zhongdong Hospital Southeast University
Nanjing, China
Not Yet Recruiting
13
Shanghai General Hospital
Shanghai, China
Actively Recruiting
14
Renmin Hospital Of Wuhan University
Wuhan, China
Not Yet Recruiting
15
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi'an, China
Not Yet Recruiting
16
The First Affiliated Hospital Of Xiamen University
Xiamen, China
Not Yet Recruiting
17
Su Bei People's Hospital
Yangzhou, China
Not Yet Recruiting
Research Team
Q
Qi Jin
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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