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

Primary Purpose

Membranous Nephropathy

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
efgartigimod IV
placebo
Sponsored by
argenx
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Membranous Nephropathy focused on measuring kidney disease, Glomerulonephritis membranous, Urologic disease, glomerulonephritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Investigator site 1004Recruiting
  • Investigator site 1061Recruiting
  • Investigator site 1056Recruiting
  • Investigator site 1054Recruiting
  • Investigator site 1001Recruiting
  • Investigator site 1010Recruiting
  • Investigator site 1008Recruiting
  • Investigator site 1012Recruiting
  • Investigator site 1013Recruiting
  • Investigator site 1046Recruiting
  • Investigator site 1016Recruiting
  • Investigator site 1017Recruiting
  • Investigator site 1018Recruiting
  • Investigator site 1019Recruiting
  • Investigator site 1021Recruiting
  • Investigator site 1027Recruiting
  • Investigator site 1028Recruiting
  • Investigator site 1003Recruiting
  • Investigator site 1031Recruiting
  • Investigator site 1057Recruiting
  • Investigator site 1034Recruiting
  • Investigator site 1045Recruiting
  • Investigator site 1036Recruiting
  • Investigator site 1051Recruiting
  • Investigator site 1025Recruiting
  • Investigator site 1044Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

efgartigimod IV

placebo

Arm Description

patients receiving infusions of efgartigimod

patients receiving infusions of placebo

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change from baseline to week 24 in urine protein creatinine ratio (UPCR) in overall population
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 to complete remission (CR) in overall population and anti-PLA2R Ab seropositive population
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 to partial remission (PR) in overall population and anti-PLA2R Ab seropositive population
Change from baseline to week 24 in anti-PLA2R Ab in anti-PLA2R Ab seropositive population
Change from baseline to week 24 in serum albumin in overall population and anti-PLA2R Ab seropositive population
Change from baseline to week 24 in estimated glomerular filtration rate (eGFR) in overall population and anti-PLA2R Ab seropositive population
Treatment failure rate during treatment period in overall population and anti-PLA2R Ab seropositive population
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
Efgartigimod serum concentration-time profile in overall population and anti-PLA2R Ab seropositive population
changes from baseline in levels of total IgG
Incidence of antidrug antibodies (ADA) against efgartigimod in overall population and anti-PLA2R Ab seropositive population
Change from baseline in EQ5D-5L score in overall population and anti-PLA2R Ab seropositive population
Change from baseline in PROMIS Short form v1.0 Fatigue-4a questionnaire in overall population and anti-PLA2R Ab seropositive population

Full Information

First Posted
March 29, 2023
Last Updated
October 2, 2023
Sponsor
argenx
Collaborators
Zai Lab Pty. Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05810961
Brief Title
A Study to Assess Effectiveness and Safety of Efgartigimod in Chinese Patients With Primary Membranous Nephropathy (ZL-1103-014)
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 20, 2023 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
argenx
Collaborators
Zai Lab Pty. Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Membranous Nephropathy
Keywords
kidney disease, Glomerulonephritis membranous, Urologic disease, glomerulonephritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
efgartigimod IV
Arm Type
Experimental
Arm Description
patients receiving infusions of efgartigimod
Arm Title
placebo
Arm Type
Experimental
Arm Description
patients receiving infusions of placebo
Intervention Type
Biological
Intervention Name(s)
efgartigimod IV
Intervention Description
infusion of efgartigimod
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
infusion of placebo
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Change from baseline to week 24 in urine protein creatinine ratio (UPCR) in overall population
Time Frame
up to 24 weeks
Title
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
Title
Time to complete remission (CR) in overall population and anti-PLA2R Ab seropositive population
Time Frame
up to 32 weeks
Title
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
Title
Time to partial remission (PR) in overall population and anti-PLA2R Ab seropositive population
Time Frame
up to 32 weeks
Title
Change from baseline to week 24 in anti-PLA2R Ab in anti-PLA2R Ab seropositive population
Time Frame
up to 24 weeks
Title
Change from baseline to week 24 in serum albumin in overall population and anti-PLA2R Ab seropositive population
Time Frame
up to 24 weeks
Title
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
Title
Treatment failure rate during treatment period in overall population and anti-PLA2R Ab seropositive population
Time Frame
up to 32 weeks
Title
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
Title
Efgartigimod serum concentration-time profile in overall population and anti-PLA2R Ab seropositive population
Time Frame
up to 32 weeks
Title
changes from baseline in levels of total IgG
Time Frame
up to 32 weeks
Title
Incidence of antidrug antibodies (ADA) against efgartigimod in overall population and anti-PLA2R Ab seropositive population
Time Frame
up to 32 weeks
Title
Change from baseline in EQ5D-5L score in overall population and anti-PLA2R Ab seropositive population
Time Frame
up to 24 weeks
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Information:
Facility Name
Investigator site 1004
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 1061
City
Changsha
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
Clinicaltrials@argenx.com
Facility Name
Investigator site 1056
City
Chongqing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 1054
City
Fujian
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 1001
City
Guangzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
Clinicaltrials@argenx.com
Facility Name
Investigator site 1010
City
Guangzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
Clinicaltrials@argenx.com
Facility Name
Investigator site 1008
City
Guanzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
Clinicaltrials@argenx.com
Facility Name
Investigator site 1012
City
Hanzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 1013
City
Hefei
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
Clinicaltrials@argenx.com
Facility Name
Investigator site 1046
City
Jinan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
Clinicaltrials@argenx.com
Facility Name
Investigator site 1016
City
Liuzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
Clinicaltrials@argenx.com
Facility Name
Investigator site 1017
City
Nanchang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
Clinicaltrials@argenx.com
Facility Name
Investigator site 1018
City
Nanjing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
Clinicaltrials@argenx.com
Facility Name
Investigator site 1019
City
Nanjing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 1021
City
Nanning
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 1027
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 1028
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
Clinicaltrials@argenx.com
Facility Name
Investigator site 1003
City
Shenyang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
Clinicaltrials@argenx.com
Facility Name
Investigator site 1031
City
Shenzhen
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
Clinicaltrials@argenx.com
Facility Name
Investigator site 1057
City
Shijia Zhuang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
Clinicaltrials@argenx.com
Facility Name
Investigator site 1034
City
Tianjin
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 1045
City
Wuhan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
Clinicaltrials@argenx.com
Facility Name
Investigator site 1036
City
Wuxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
Clinicaltrials@argenx.com
Facility Name
Investigator site 1051
City
Xi'an
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 1025
City
Xiamen
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com
Facility Name
Investigator site 1044
City
Zhengzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Coppieters, MD
Phone
857-350-4834
Email
clinicaltrials@argenx.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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