Actively Recruiting
A Randomized, Controlled Study to Evaluate Safety, Tolerability, and Efficacy of HLX79 Combined With Rituximab Injection in Patients With Active Glomerulonephritis
Led by Shanghai Henlius Biotech · Updated on 2025-11-18
24
Participants Needed
17
Research Sites
173 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the safety and tolerability of HLX79 combined with HLX01 compared to placebo combined with HLX01 in treating active glomerulonephritis, specifically membranous nephropathy (MN) and lupus nephritis (LN). This phase II randomized, controlled, multicenter study aims to evaluate pharmacokinetics, pharmacodynamics, immunogenicity, and clinical efficacy of these treatments for patients with these kidney conditions. Participants will receive one of three doses of HLX79 (10, 20, or 30 mg/kg) or placebo, all combined with a fixed dose of HLX01 (375 mg/m2). After the initial treatment period, participants enter a 20-week follow-up phase, followed by assessments to determine the need for a second treatment period. Those not requiring further treatment will continue with follow-up until completing a total of 48 weeks. Throughout the study, participants undergo regular monitoring including laboratory tests to track abnormal values and adverse events related to treatment over 24 weeks. Safety, drug levels, immune responses, clinical efficacy, and biomarker changes are assessed up to 52 weeks. The study also includes long-term follow-up to observe ongoing effects and safety for nearly one year after treatment initiation.
CONDITIONS
Brief 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 must voluntarily agree to participate and complete all study procedures
- Male or female aged 18 to 75 years
- Diagnosed with primary membranous nephropathy within 5 years prior to screening
- Have a renal biopsy diagnosis or positive anti-PLA2R antibody test within 6 months prior to screening
- Exclude secondary membranous nephropathy causes
- Have received ACEIs/ARBs at the highest tolerated dose for 3 months prior to screening unless intolerant
- Meet at least one high-risk criterion: urine protein >8 g/24 h, or eGFR ≥60 mL/min/1.73 m2 and urine protein >3.5 g/24 h at screening
- Women of childbearing potential must have a negative pregnancy test at screening
- Agree to use effective contraception from signing the consent until 12 months after last dose
You will not qualify if you...
- Pregnant or lactating women, or positive pregnancy test before randomization
- Women or partners planning pregnancy during the study
- Drug or alcohol abuse history within 1 year prior to screening
- History or risk of malignancy except certain skin or cervical cancers within 5 years
- History or planned organ, stem cell, or bone marrow transplantation
- Primary immunodeficiency or diabetes mellitus (type 1 or type 2 with diabetic nephropathy excluded)
- Unstable or poorly controlled major diseases or Grade 3+ medical abnormalities
- End-stage renal disease requiring transplant or dialysis, or oliguria
- Active or recent serious infections within 2 months prior to randomization
- Lung imaging suggesting tuberculosis infection
- Abnormal ECG with prolonged QTc interval
- Abnormal lab results including low blood counts, elevated liver enzymes, low eGFR, coagulation abnormalities, positive infectious disease tests
- History of serious allergic reactions to study drugs or related substances
- Recent treatment with certain immunosuppressive or targeted drugs within specified time frames
- Recent immunoglobulin infusion or plasma exchange
- Participation in other investigational drug or device studies within defined intervals
- Recent live or live attenuated vaccines
- Use of herbal or traditional medicines with therapeutic effects for MN within 14 days prior to randomization
- Inability or unwillingness to undergo repeated venipuncture
- Recent large blood donation or planned donation during study
- Investigator judgment that participation may harm subject's rights or interests
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 24 weeks
Participants receive HLX79 at varying doses combined with HLX01 as part of the study treatment for active glomerulonephritis.
Duration - Up to 52 weeks
Participants are monitored for safety, efficacy, pharmacokinetics, immunogenicity, and biomarker assessments after treatment ends.
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
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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