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Trial · NCT04287985

Outcomes21

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYNumber of Participants With Adverse Events Graded by SeverityBaseline to End of Study (16 months)Safety PopulationParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYChanges From Baseline in Clinical Laboratory TestsBaseline to End of Study (16 months)Safety populationParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYClinically Meaningful Changes From Baseline in Vital SignsBaseline to End of Study (16 months)Safety populationParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYClinically Significant Physical ExaminationsBaseline to End of Study (16 months)Safety populationParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYChange From Baseline in uPCR: Month 1212 monthsmodified intent-to-treat (mITT) Populationg/gLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in uPCR: Months 9 and 16Baseline to 9 months and 16 months (16 months total)modified intent-to-treat (mITT) Populationg/gLEAST_SQUARES_MEAN
SECONDARYChange in 24-hour Urine Protein Excretion: Months 12 and 1616 monthsmodified intent-to-treat (mITT) Populationmg/dayGEOMETRIC_MEAN
SECONDARYParticipants Achieving a Greater Than or Equal to 30% Decline From Baseline in uPCR at Months 9, 12, and 16Baseline to 9,12, and 16 months (16 months total)modified intent-to-treat (mITT) PopulationParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYParticipants in Each Group Achieving Clinical RemissionBaseline to End of Study (16 months)modified intent-to-treat (mITT) PopulationParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYChange From Baseline in eGFR at Months 9, 12, and 16Baseline to 12 and 16 monthsmodified intent-to-treat (mITT) PopulationmL/min/1.73 m^2MEAN
SECONDARYPercent Change From Baseline in Total Serum IgA, IgG, and IgM Concentrations at Months 12 and 16Baseline to 12 and 16 monthsPharmacodynamic Populationpercentage changeMEAN
SECONDARYMean Serum PK Parameters at Month 0 and Month 11: CmaxMonths 0 and 11Intensive Pharmacokinetic Populationμg/mLMEAN
SECONDARYMedian Serum PK Parameters at Month 0 and Month 11: TmaxMonth 0 and Month 11Intensive Pharmacokinetic PopulationdaysMEDIAN
SECONDARYMean Serum PK Parameters at Month 0: AUC0-inf and AUC0-30Month 0Intensive pharmacokinetic populationday∙μg/mLMEAN
SECONDARYMean Serum PK Parameters at Month 0 and Month 11: t1/2zMonth 0 and Month 11Intensive Pharmacokinetic PopulationdaysMEAN
SECONDARYMedian Serum PK Parameters at Month 0: CLMonth 0Intensive pharmacokinetic populationmL/dayMEDIAN
SECONDARYMean Serum PK Parameters at Month 0: VzMonth 0Intensive pharmacokinetic populationmLMEAN
SECONDARYMean Serum PK Parameters at Month 11: AUCτMonth 11Intensive Pharmacokinetic Populationday∙μg/mLMEAN
SECONDARYMean Serum PK Parameters at Month 11: VssMonth 11Intensive Pharmacokinetic PopulationmL/kgMEAN
SECONDARYMean Serum PK Parameters at Month 11: CLssMonth 11Intensive Pharmacokinetic PopulationmL/dayMEAN

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license 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.

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