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Membranous NephropathyPhase 2NCT05810961

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

A Phase 2 study testing efgartigimod IV in people with Membranous Nephropathy, run by argenx at 31 sites in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Membranous Nephropathy
What is being tested?
efgartigimod IV
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
8 participants
Where
31 sitesChina
Study dates
20 Feb 2023to 5 Aug 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 17Show fewer
  • 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

Trial locations and contacts

31 sites in 1 country.

31 sites in 1 country

China31 sites

  • Peking University People's Hospital

    Beijing

  • Hunan Provincial People's Hospital

    Changsha

  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing

  • Fujian Medical University Union Hospital

    Fujian

  • Fuyang People's Hospital

    Fuyang

  • Guangdong Provincial People's Hospital

    Guangzhou

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

    Guangzhou

  • The First Affiliated Hospital, Sun Yat-sen University

    Guanzhou

  • The First Affiliated Hospital, Zhejiang University

    Hanzhou

  • The Second Hospital of Anhui Medical University

    Hefei

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

    Huai'an, 223300

  • Shandong Provincial Hospital Affiliated to Shandong First Medical University

    Jinan

  • Liu Zhou Works Hospital

    Liuzhou

  • The First Affiliated Hospital of Nanchang University

    Nanchang

  • Jiangsu Province Hospital

    Nanjing

  • Zhongda Hospital Southeast University

    Nanjing

  • The People's Hospital of Guangxi Zhuang Autonomous Region

    Nanning

  • Pingxiang People's Hospital

    Pingxiang, 337055

  • Huashan Hospital Fudan University

    Shanghai

  • Renji Hospital Shanghai Jiaotong University School of Medicine

    Shanghai

  • ShengJing Hospital of China Medical University

    Shenyang

  • Shenzhen People's Hospital

    Shenzhen

  • The First Hospital of Hebei Medical University

    Shijia Zhuang

  • The Second Hospital of Tianjin Medical University

    Tianjin

  • Renmin Hospital of Wuhan University

    Wuhan

  • Wuxi People's Hospital

    Wuxi

  • Shaanxi Provincial Hospital of Chinese Medicine

    Xi'an

  • The First Affiliated Hospital of Xiamen University

    Xiamen

  • Xiamen Fifth Hospital

    Xiamen

  • Henan Provincial People's Hospital

    Zhengzhou

  • Zhuhai People's Hospital

    Zhuhai, 519099

Other trials in China

About this study

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

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

Read the 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

Being tested
efgartigimod IV, placebo
Keywords
kidney disease, Glomerulonephritis membranous, Urologic disease, glomerulonephritis
Medical subject headings
Glomerulonephritis, Membranous, Kidney Diseases, Urologic Diseases, Glomerulonephritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • efgartigimod IVBiological

    infusion of efgartigimod

  • placeboOther

    infusion of placebo

Study groups in NCT05810961
Study groupRoleWhat they receive
efgartigimod IVExperimentalpatients receiving infusions of efgartigimod
Receives: Biological: efgartigimod IV
placeboExperimentalpatients receiving infusions of placebo
Receives: Other: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: up to 24 weeks

Secondary outcomes (15)

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

    Measured: up to 24 weeks

  2. 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

    Measured: up to 24 weeks

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

    Measured: up to 32 weeks

  4. 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

    Measured: up to 24 weeks

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

    Measured: up to 32 weeks

  6. Change from baseline to week 24 in anti-PLA2R Ab in anti-PLA2R Ab seropositive population

    Measured: up to 24 weeks

  7. Change from baseline to week 24 in serum albumin in overall population and anti-PLA2R Ab seropositive population

    Measured: up to 24 weeks

  8. Change from baseline to week 24 in estimated glomerular filtration rate (eGFR) in overall population and anti-PLA2R Ab seropositive population

    Measured: up to 24 weeks

  9. Treatment failure rate during treatment period in overall population and anti-PLA2R Ab seropositive population

    Measured: up to 32 weeks

  10. 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

    Measured: up to 32 weeks

  11. Efgartigimod serum concentration-time profile in overall population and anti-PLA2R Ab seropositive population

    Measured: up to 32 weeks

  12. changes from baseline in levels of total IgG

    Measured: up to 32 weeks

  13. Incidence of antidrug antibodies (ADA) against efgartigimod in overall population and anti-PLA2R Ab seropositive population

    Measured: up to 32 weeks

  14. Change from baseline in EQ5D-5L score in overall population and anti-PLA2R Ab seropositive population

    Measured: up to 24 weeks

  15. Change from baseline in PROMIS Short form v1.0 Fatigue-4a questionnaire in overall population and anti-PLA2R Ab seropositive population

    Measured: up to 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2023
  2. Study start20 Feb 2023
  3. Primary completion5 Aug 2024
  4. Study completion5 Aug 2024

Why it stopped: Sponsor decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05810961
Sponsor's protocol ID
ARGX-113-2203
Status last verified
Nov 2024
First submitted
29 Mar 2023
Last updated
22 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing efgartigimod IV in people with Membranous Nephropathy, run by argenx at 31 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05810961.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2024.

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