Trial · NCT05810961
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change from baseline to week 24 in urine protein creatinine ratio (UPCR) in anti- PLA2R antibody (Ab) seropositive population | up to 24 weeks | |
| Secondary | Change from baseline to week 24 in urine protein creatinine ratio (UPCR) in overall population | up to 24 weeks | |
| Secondary | 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 | |
| Secondary | Time to complete remission (CR) in overall population and anti-PLA2R Ab seropositive population | up to 32 weeks | |
| Secondary | 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 | |
| Secondary | Time to partial remission (PR) in overall population and anti-PLA2R Ab seropositive population | up to 32 weeks | |
| Secondary | Change from baseline to week 24 in anti-PLA2R Ab in anti-PLA2R Ab seropositive population | up to 24 weeks | |
| Secondary | Change from baseline to week 24 in serum albumin in overall population and anti-PLA2R Ab seropositive population | up to 24 weeks | |
| Secondary | Change from baseline to week 24 in estimated glomerular filtration rate (eGFR) in overall population and anti-PLA2R Ab seropositive population | up to 24 weeks | |
| Secondary | Treatment failure rate during treatment period in overall population and anti-PLA2R Ab seropositive population | up to 32 weeks | |
| Secondary | 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 | up to 32 weeks | |
| Secondary | Efgartigimod serum concentration-time profile in overall population and anti-PLA2R Ab seropositive population | up to 32 weeks | |
| Secondary | changes from baseline in levels of total IgG | up to 32 weeks | |
| Secondary | Incidence of antidrug antibodies (ADA) against efgartigimod in overall population and anti-PLA2R Ab seropositive population | up to 32 weeks | |
| Secondary | Change from baseline in EQ5D-5L score in overall population and anti-PLA2R Ab seropositive population | up to 24 weeks | |
| Secondary | Change from baseline in PROMIS Short form v1.0 Fatigue-4a questionnaire in overall population and anti-PLA2R Ab seropositive population | up to 24 weeks |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT05810961/registered