A Study to Assess Effectiveness and Safety of Efgartigimod in Chinese Patients with Primary Membr… (NCT05810961) | Clinical Trial Compass
TerminatedPhase 2
A Study to Assess Effectiveness and Safety of Efgartigimod in Chinese Patients with Primary Membranous Nephropathy (ZL-1103-014)
Stopped: Sponsor decision
China8 participantsStarted 2023-02-20
Plain-language summary
To evaluate the efficacy and safety of efgartigimod IV in Chinese patients with primary membranous nephropathy (pMN).
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 transp…
What they're measuring
1
Change from baseline to week 24 in urine protein creatinine ratio (UPCR) in anti- PLA2R antibody (Ab) seropositive population