BridgeMD
Compares treatment options for Membranous Nephropathy
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
ClinicalTrials.gov ID: NCT07038382
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Patients who voluntarily participate in this clinical study, fully understand and have been informed about the study, have signed the informed...
- Male or female, aged 18-75 years (both inclusive) at the time of signing the ICF.
- Diagnosed with primary membranous nephropathy (MN) within 5 year prior to screening
- If a diagnosis of primary MN is confirmed, a renal biopsy pathological diagnosis prior to screening or a renal biopsy diagnosis obtained during...
- Urine protein \> 8 g/24 h at screening.(The above 3-month ACEI/ARB treatment observation period is not required)
You likely can't join if
- Pregnant or lactating women, or those with a positive blood pregnancy test prior to randomization.
- WOCBP or partners of male people who plan to become pregnant during the study.
- History of drug or alcohol abuse within 1 year prior to screening.
- Malignancy or increased risk of malignancy prior to screening: suspected and/or diagnosed with any malignancy (except for basal cell carcinoma...
- History of organ transplantation or stem cell or bone marrow transplantation prior to screening, or plan to undergo the above-mentioned...
- Complicated with primary immunodeficiency diseases, type 1 diabetes mellitus, and type 2 diabetes mellitus (Type 2 diabetic patients with a renal...
See the full eligibility criteria
Who can join
- Patients who voluntarily participate in this clinical study, fully understand and have been informed about the study, have signed the informed consent form (ICF), and are willing to follow and able to complete all study...
- Male or female, aged 18-75 years (both inclusive) at the time of signing the ICF.
- Diagnosed with primary membranous nephropathy (MN) within 5 year prior to screening
- If a diagnosis of primary MN is confirmed, a renal biopsy pathological diagnosis prior to screening or a renal biopsy diagnosis obtained during screening should be available, or patients with nephrotic syndrome and a...
- Urine protein \> 8 g/24 h at screening.(The above 3-month ACEI/ARB treatment observation period is not required)
- eGFR ≥ 60 mL/min/1.73 m2 and urine protein \> 3.5 g/24 h at screening
- Women of childbearing potential (WOCBP) must undergo a pregnancy test at screening and obtain a negative result.
- WOCBP or male people must agree to take effective contraceptive measures starting from signing the ICF until 12 months after the last dose of the investigational medicinal product (IMP).
What rules you out
- Pregnant or lactating women, or those with a positive blood pregnancy test prior to randomization.
- WOCBP or partners of male people who plan to become pregnant during the study.
- History of drug or alcohol abuse within 1 year prior to screening.
- Malignancy or increased risk of malignancy prior to screening: suspected and/or diagnosed with any malignancy (except for basal cell carcinoma, squamous cell carcinoma of skin in situ, or cervical carcinoma in situ...
- History of organ transplantation or stem cell or bone marrow transplantation prior to screening, or plan to undergo the above-mentioned transplantations during the study.
- Complicated with primary immunodeficiency diseases, type 1 diabetes mellitus, and type 2 diabetes mellitus (Type 2 diabetic patients with a renal biopsy report within one year prior to screening that excludes diabetic...
- Presence of the following diseases that are significantly unstable or poorly controlled at screening: cardiovascular disorder, hematological disease, respiratory disorder, digestive system disorder, endocrine and...
- End-stage renal disease requiring kidney transplantation or dialysis, or oliguria (urine volume \< 400 mL/24 h) at screening or prior to randomization.
- Acute, recurrent, or chronic infection (including but not limited to tuberculosis, pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster, or atypical mycobacterial infection) at screening,
- Infection requiring intravenous or intramuscular injection of anti-infective drugs within 2 months prior to randomization, or infection requiring hospitalization within 2 months prior to randomization.
- Lung CT or chest X-ray at screening suggesting tuberculosis infection or previous tuberculosis infection.
- Abnormalities in 12-lead ECG at screening, such as corrected QT (QTc) interval \> 450 ms in males and corrected QT (QTc) interval \> 470 ms in females (Fridericia's method).
- Abnormal results of the following laboratory tests at screening:
- Hemoglobin \< 90 g/L, or platelet count \< 100 × 109 L, or neutrophil count \< 1.5 × 109 L.
- Alkaline phosphatase (ALP) \> 2 × upper limit of normal (ULN), or total bilirubin (TB) \> 2 × ULN, or alanine aminotransferase (ALT) \> 2 × ULN, or aspartate aminotransferase (AST) \> 2 × ULN, or blood amylase \> 1.5 ×...
- Estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m2.
- International normalized ratio (INR) \> 2.5 (not on anticoagulant therapy).
- Interferon gamma release assay positive.
- Serological test positive for human immunodeficiency virus (HIV) antibodies.
- Test results positive for treponema pallidum (syphilis).
- Positive for hepatitis B virus (HBV) surface antigen (HBsAg), or positive for HBV core antibody (HBcAb) and HBV deoxyribonucleic acid (HBV-DNA).
- Hepatitis C virus (HCV) infection (HCV antibody positive with HCV-RNA \> ULN).
- History of serious drug allergy before screening: history of allergy to two or more drugs, or history of allergy or serious side effects to HLX01, HLX79, or their excipients, or history of anaphylaxis to intravascular...
- History of or need for treatment with one of the following drugs prior to screening:
- Treatment with glucocorticoids, MMF (or other forms of mycophenolate) within 1 month prior to randomization
- Treatment with calcineurin inhibitors (CNIs) such as tacrolimus and cyclosporine A or other immunosuppressive agents within 3 months prior to randomization
- Treatment with alkylating agents such as cyclophosphamide (CYC) and ifosfamide within 6 months prior to randomization
- people who still require treatment with glucocorticoids, MMF (or other forms of mycophenolate), or alkylating agents or other immunosuppressive agents during the study as judged by the investigator at screening.
- Have received treatment with abatacept, telitacicept, JAK inhibitors, thalidomide, lenalidomide, bortezomib, cladribine, belimumab, rituximab, or other targeted drugs (T lymphocytes, B lymphocytes, interleukin-1...
- Have received intravenous infusion of immunoglobulin or plasma exchange within 3 months prior to randomization.
- Have participated in a clinical study of other investigational medicinal products prior to screening, with an interval between this study and the previous study being too short: within 1 month prior to the first...
- Have participated in surgical or device clinical studies within 3 months prior to screening or plan to participate in other surgical or device clinical studies during this clinical study.
- Have received any live or live attenuated vaccine within 3 months prior to screening, or plan to receive any live or live attenuated vaccine during the study.
- Use of herbal medicines, traditional Chinese medicines, or local traditional remedies that have therapeutic effects for MN within 14 days prior to randomization.
- Unable to establish venous access due to poor side effects or difficulty in finding veins, or unable or unwilling to undergo repeated venipuncture.
- Donated whole blood or blood components (more than 400 mL) or lost a large amount of blood (more than 400 mL) within 2 months prior to screening, or plan to donate whole blood or blood components during the study.
- The investigator has a clear reason to believe that participation in this study will damage the rights and interests of the subject.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
- Changsha, China
- Guangzhou, China
- Hangzhou, China
- Hefei, China
- Luoyang, China
- Nanchang, China
- Nanjing, China
- Shanghai, China
- Wuhan, China
- Xi'an, China
- Xiamen, China
- Yangzhou, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China; Changsha, China; Guangzhou, China; Hangzhou, China; Hefei, China; Luoyang, China and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.