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

March 15, 2024 updated by: argenx

A Multicenter, Randomized, Double-blinded, Placebo-controlled, Proof-of-Concept Study to Evaluate the Efficacy and Safety of Efgartigimod in Chinese Patients With Primary Membranous Nephropathy

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

72

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Peking University People's Hospital
        • Contact:
      • Changsha, China
        • Recruiting
        • Hunan Provincial People's Hospital
        • Contact:
      • Chongqing, China
        • Recruiting
        • The Second Affiliated Hospital of Chongqing Medical University
        • Contact:
      • Fujian, China
        • Recruiting
        • Fujian Medical University Union Hospital
        • Contact:
      • Fuyang, China
      • Guangzhou, China
        • Recruiting
        • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
        • Contact:
      • Guangzhou, China
        • Recruiting
        • Guangdong Provincial People's Hospital
        • Contact:
      • Guanzhou, China
        • Recruiting
        • The First Affiliated Hospital, Sun Yat-sen University
        • Contact:
      • Hanzhou, China
        • Recruiting
        • The First Affiliated Hospital, Zhejiang University
        • Contact:
      • Hefei, China
        • Recruiting
        • The Second Hospital of Anhui Medical University
        • Contact:
      • Huai'an, China, 223300
        • Recruiting
        • The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University
        • Contact:
      • Jinan, China
        • Recruiting
        • Shandong Provincial Hospital Affiliated to Shandong First Medical University
        • Contact:
      • Liuzhou, China
      • Nanchang, China
        • Recruiting
        • The First Affiliated Hospital of Nanchang University
        • Contact:
      • Nanjing, China
        • Recruiting
        • Zhongda Hospital Southeast University
        • Contact:
      • Nanjing, China
        • Recruiting
        • Jiangsu Province Hospital
        • Contact:
      • Nanning, China
        • Recruiting
        • The People's Hospital of Guangxi Zhuang Autonomous Region
        • Contact:
      • Pingxiang, China, 337055
        • Recruiting
        • Pingxiang People's Hospital
        • Contact:
      • Shanghai, China
        • Recruiting
        • Huashan Hospital Fudan University
        • Contact:
      • Shanghai, China
        • Recruiting
        • Renji Hospital Shanghai Jiaotong University School of Medicine
        • Contact:
      • Shenyang, China
        • Recruiting
        • Shengjing Hospital of China Medical University
        • Contact:
      • Shenzhen, China
      • Shijia Zhuang, China
        • Recruiting
        • The First Hospital of Hebei Medical University
        • Contact:
      • Tianjin, China
        • Recruiting
        • The Second Hospital of Tianjin Medical University
        • Contact:
      • Wuhan, China
        • Recruiting
        • Renmin Hospital of Wuhan University
        • Contact:
      • Wuxi, China
      • Xi'an, China
        • Recruiting
        • Shaanxi Provincial Hospital of Chinese Medicine
        • Contact:
      • Xiamen, China
        • Recruiting
        • The First Affiliated Hospital of Xiamen University
        • Contact:
      • Xiamen, China
      • Zhengzhou, China
        • Recruiting
        • Henan Provincial People's Hospital
        • Contact:
      • Zhuhai, China, 519099

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: efgartigimod IV
patients receiving infusions of efgartigimod
Biological: efgartigimod IV
infusion of efgartigimod
Experimental: placebo
patients receiving infusions of placebo
Other: placebo
infusion of placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline to week 24 in urine protein creatinine ratio (UPCR) in anti- PLA2R antibody (Ab) seropositive population
Time Frame: up to 24 weeks
up to 24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline to week 24 in urine protein creatinine ratio (UPCR) in overall population
Time Frame: up to 24 weeks
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
Time Frame: up to 24 weeks
up to 24 weeks
Time to complete remission (CR) in overall population and anti-PLA2R Ab seropositive population
Time Frame: up to 32 weeks
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
Time Frame: up to 24 weeks
up to 24 weeks
Time to partial remission (PR) in overall population and anti-PLA2R Ab seropositive population
Time Frame: up to 32 weeks
up to 32 weeks
Change from baseline to week 24 in anti-PLA2R Ab in anti-PLA2R Ab seropositive population
Time Frame: up to 24 weeks
up to 24 weeks
Change from baseline to week 24 in serum albumin in overall population and anti-PLA2R Ab seropositive population
Time Frame: up to 24 weeks
up to 24 weeks
Change from baseline to week 24 in estimated glomerular filtration rate (eGFR) in overall population and anti-PLA2R Ab seropositive population
Time Frame: up to 24 weeks
up to 24 weeks
Treatment failure rate during treatment period in overall population and anti-PLA2R Ab seropositive population
Time Frame: up to 32 weeks
up to 32 weeks
Incidence of relapse, defined as the development of nephrotic range proteinuria following CR or PR, ie, >3.5g/24-hour throughout the study in overall population and anti-PLA2R Ab seropositive population
Time Frame: up to 32 weeks
up to 32 weeks
Efgartigimod serum concentration-time profile in overall population and anti-PLA2R Ab seropositive population
Time Frame: up to 32 weeks
up to 32 weeks
changes from baseline in levels of total IgG
Time Frame: up to 32 weeks
up to 32 weeks
Incidence of antidrug antibodies (ADA) against efgartigimod in overall population and anti-PLA2R Ab seropositive population
Time Frame: up to 32 weeks
up to 32 weeks
Change from baseline in EQ5D-5L score in overall population and anti-PLA2R Ab seropositive population
Time Frame: up to 24 weeks
up to 24 weeks
Change from baseline in PROMIS Short form v1.0 Fatigue-4a questionnaire in overall population and anti-PLA2R Ab seropositive population
Time Frame: up to 24 weeks
up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

argenx

Collaborators

Zai Lab Pty. Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2023

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

March 29, 2023

First Submitted That Met QC Criteria

April 11, 2023

First Posted (Actual)

April 13, 2023

Study Record Updates

Last Update Posted (Actual)

March 18, 2024

Last Update Submitted That Met QC Criteria

March 15, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARGX-113-2203

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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