A Study to Assess Effectiveness and Safety of Efgartigimod in Chinese Patients with Primary Membranous Nephropathy (ZL-1103-014)
NCT ID: NCT05810961
Last Updated: 2024-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE2
8 participants
INTERVENTIONAL
2023-02-20
2024-08-05
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluate the Efficacy and Safety of SHR1459 Tablets in Patients With Primary Membranous Nephropathy
NCT05136456
A Study to Test How Kidney Problems Influence the Blood Concentrations of Efgartigimod
NCT05927415
Efficacy and Safety of SHR-2010 Injection in the Treatment of Primary IgA Nephropathy
NCT05847920
Efficacy of Immunosuppressive Therapy for IgA Nephropathy With Stage 3 or 4 CKD
NCT05510323
A Study to Examine the Efficacy and Safety of Zanubrutinib Given to Adults With Primary Membranous Nephropathy
NCT05707377
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
efgartigimod IV
patients receiving infusions of efgartigimod
efgartigimod IV
infusion of efgartigimod
placebo
patients receiving infusions of placebo
placebo
infusion of placebo
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
efgartigimod IV
infusion of efgartigimod
placebo
infusion of placebo
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Capable of providing signed informed consent and complying with protocol requirements
* Diagnosis of idiopathic (primary) MN confirmed by renal biopsy within 24 months before randomization. A renal biopsy may be taken at any time during the screening period to confirm the diagnosis of MN for participant eligibility, if the most recent biopsy was performed greater than 24 months before randomization
* Receiving stable dose at maximum tolerated or allowed dose of ACEi and/or ARB for at least 12 weeks before randomization
Exclusion Criteria
* Diagnostic renal biopsy showing evidence of crescent formation in glomeruli, suggestive of an alternative or additional diagnosis to pMN; evidence on renal biopsy of \>50% interstitial fibrosis/tubular atrophy in the cortical area
* History of malignancy unless deemed cured by adequate treatment with no evidence of recurrence for ≥3 years before randomization.
* Any evidence of diabetic glomerulopathy on renal biopsy that is:
Greater than Class I diabetic glomerulopathy, or Class I diabetic glomerulopathy with a history of poor diabetic control (eg, HbA1c ≥9.0%) since time of biopsy
* Currently on renal dialysis or expected to require dialysis during study period
* Previous kidney transplantation or planned transplantation during study period
* Any other known autoimmune disease that, requires systemic immunosuppressive treatments, or in the opinion of the investigator, would interfere with an accurate assessment of clinical symptoms of pMN or put the participant at undue risk
* Clinical evidence of other significant or uncontrolled serious diseases (ie, cardiovascular, pulmonary, hematologic, gastrointestinal, hepatic, renal, neurological), have had a recent major surgery, or have any other condition, that in the opinion of the investigator, could confound the results of the study or put the participant at undue risk
* Use of complementary therapies, including Traditional Chinese Medicine, herbs, or procedures (eg, acupuncture) within 4 weeks before randomization that can potentially interfere with the efficacy and safety of participants as assessed by the investigator
* Received live/live-attenuated vaccine within 28 days before randomization. The receipt of any inactivated, subunit, polysaccharide, or conjugate vaccine at any time before screenings is not considered exclusionary. It is recommended that participants are up to date with vaccination before the first dose of IMP
* Previously participated in a clinical study with efgartigimod
* SARS-CoV-2 positive test at screening. The test is required regardless of whether the participant has been vaccinated
* Known hypersensitivity or contraindication to efgartigimod, or any excipient of the IMP
* In the opinion of the investigator, current or history of (ie, within 12 months of randomization) alcohol, drug, or medication abuse
* Pregnant or lactating females and those who intend to become pregnant during study participation
* Any conditions or circumstances that in the opinion of the investigator may make the participant unsuitable for the study
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Zai Lab Pty. Ltd.
INDUSTRY
argenx
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Peking University People's Hospital
Beijing, , China
Hunan Provincial People's Hospital
Changsha, , China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, , China
Fujian Medical University Union Hospital
Fujian, , China
Fuyang People's Hospital
Fuyang, , China
Guangdong Provincial People's Hospital
Guangzhou, , China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, , China
The First Affiliated Hospital, Sun Yat-sen University
Guanzhou, , China
The First Affiliated Hospital, Zhejiang University
Hanzhou, , China
The Second Hospital of Anhui Medical University
Hefei, , China
The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University
Huai'an, , China
Shandong Provincial Hospital Affiliated to Shandong First Medical University
Jinan, , China
Liu Zhou Works Hospital
Liuzhou, , China
The First Affiliated Hospital of Nanchang University
Nanchang, , China
Jiangsu Province Hospital
Nanjing, , China
Zhongda Hospital Southeast University
Nanjing, , China
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, , China
Pingxiang People's Hospital
Pingxiang, , China
Huashan Hospital Fudan University
Shanghai, , China
Renji Hospital Shanghai Jiaotong University School of Medicine
Shanghai, , China
ShengJing Hospital of China Medical University
Shenyang, , China
Shenzhen People's Hospital
Shenzhen, , China
The First Hospital of Hebei Medical University
Shijia Zhuang, , China
The Second Hospital of Tianjin Medical University
Tianjin, , China
Renmin Hospital of Wuhan University
Wuhan, , China
Wuxi People's Hospital
Wuxi, , China
Shaanxi Provincial Hospital of Chinese Medicine
Xi'an, , China
The First Affiliated Hospital of Xiamen University
Xiamen, , China
Xiamen Fifth Hospital
Xiamen, , China
Henan Provincial People's Hospital
Zhengzhou, , China
Zhuhai People's Hospital
Zhuhai, , China
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ARGX-113-2203
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.