A Study to Assess Effectiveness and Safety of Efgartigimod in Chinese Patients With Primary Membranous Nephropathy (ZL-1103-014)

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Description

To evaluate the efficacy and safety of efgartigimod IV in Chinese patients with primary membranous nephropathy (pMN).

Targeted Conditions

Study Overview

Start Date
February 20, 2023
Completion Date
October 1, 2024
Enrollment
72
Date Posted
April 13, 2023
Accepts Healthy Volunteers?
No
Gender
All

Locations

Full Address
Peking University People's Hospital
Beijing 223300, China

Hunan Provincial People's Hospital
Changsha 337055, China

The Second Affiliated Hospital of Chongqing Medical University
Chongqing 519099, China

Fujian Medical University Union Hospital
Fujian, 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

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

Eligibility

Minimum Age (years)
18
Eligibility Criteria
Inclusion Criteria:

Aged ≥18 years when signing the informed consent form (ICF)
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
Agree to use contraceptives consistent with local regulations. Full inclusion criteria can be found in the protocol

Exclusion Criteria:

Active or chronic infection requiring treatment
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

Study Contact Info

Study Contact Name
Sabine Coppieters, MD
Study Contact Email
Study Contact Phone

Contact Listings Owner Form

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Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
No
Detailed Description
To evaluate the efficacy and safety of efgartigimod IV in Chinese patients with primary membranous nephropathy (pMN).The study comprises a maximum 4-week screening period, a 24-week treatment period, and an 8-week follow-up period
NCTid (if applicable)
NCT05810961