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

NCT05810961 | Terminated Phase 2

• 1 other identifier: ARGX-113-2203
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 31

Brief Summary

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

Conditions

Membranous Nephropathy

Keywords

kidney disease; Glomerulonephritis membranous; Urologic disease; glomerulonephritis

Outcome Measures

Primary Outcomes (1)

• Change from baseline to week 24 in urine protein creatinine ratio (UPCR) in anti- PLA2R antibody (Ab) seropositive population

  up to 24 weeks

Secondary Outcomes (15)

• Change from baseline to week 24 in urine protein creatinine ratio (UPCR) in overall population

  up to 24 weeks

• Proportion of participants achieving complete remission (CR), defined as proteinuria ≤0.3g/24-hour and serum albumin ≥3.5g/dL, at week 24 in overall population and anti-PLA2R Ab seropositive population

  up to 24 weeks

• Time to complete remission (CR) in overall population and anti-PLA2R Ab seropositive population

  up to 32 weeks

• Proportion of participants achieving partial remission (PR), defined as ≥50% reduction in proteinuria from baseline AND final proteinuria between 0.3 to 3.5g/24-hour, at week 24 in overall population and anti-PLA2R Ab seropositive population

  up to 24 weeks

• Time to partial remission (PR) in overall population and anti-PLA2R Ab seropositive population

  up to 32 weeks

Study Arms (2)

efgartigimod IV

EXPERIMENTAL

patients receiving infusions of efgartigimod

Biological: efgartigimod IV

placebo

EXPERIMENTAL

patients receiving infusions of placebo

Other: placebo

Interventions

efgartigimod IV BIOLOGICAL

infusion of efgartigimod

efgartigimod IV

placebo OTHER

infusion of placebo

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• argenx: lead
• Zai Lab Pty. Ltd.: collaborator

Study Sites (31)

Peking University People's Hospital

Beijing, China

Location

Hunan Provincial People's Hospital

Changsha, China

Location

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, China

Location

Fujian Medical University Union Hospital

Fujian, China

Location

Fuyang People's Hospital

Fuyang, China

Location

Guangdong Provincial People's Hospital

Guangzhou, China

Location

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, China

Location

The First Affiliated Hospital, Sun Yat-sen University

Guanzhou, China

Location

The First Affiliated Hospital, Zhejiang University

Hanzhou, China

Location

The Second Hospital of Anhui Medical University

Hefei, China

Location

The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University

Huai'an, 223300, China

Location

Shandong Provincial Hospital Affiliated to Shandong First Medical University

Jinan, China

Location

Liu Zhou Works Hospital

Liuchow, China

Location

The First Affiliated Hospital of Nanchang University

Nanchang, China

Location

Jiangsu Province Hospital

Nanjing, China

Location

Zhongda Hospital Southeast University

Nanjing, China

Location

The People's Hospital of Guangxi Zhuang Autonomous Region

Nanning, China

Location

Pingxiang People's Hospital

Pingxiang, 337055, China

Location

Huashan Hospital Fudan University

Shanghai, China

Location

Renji Hospital Shanghai Jiaotong University School of Medicine

Shanghai, China

Location

ShengJing Hospital of China Medical University

Shenyang, China

Location

Shenzhen People's Hospital

Shenzhen, China

Location

The First Hospital of Hebei Medical University

Shijia Zhuang, China

Location

The Second Hospital of Tianjin Medical University

Tianjin, China

Location

Renmin Hospital of Wuhan University

Wuhan, China

Location

Wuxi People's Hospital

Wuxi, China

Location

Shaanxi Provincial Hospital of Chinese Medicine

Xi'an, China

Location

The First Affiliated Hospital of Xiamen University

Xiamen, China

Location

Xiamen Fifth Hospital

Xiamen, China

Location

Henan Provincial People's Hospital

Zhengzhou, China

Location

Zhuhai People's Hospital

Zhuhai, 519099, China

Location

MeSH Terms

Conditions

Glomerulonephritis, Membranous; Kidney Diseases; Urologic Diseases; Glomerulonephritis

Condition Hierarchy (Ancestors)

Nephritis; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2023
• First Posted: April 13, 2023
• Study Start: February 20, 2023
• Primary Completion: August 5, 2024
• Study Completion: August 5, 2024
• Last Updated: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (31)