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Trial · NCT03536754

Registered outcomes56

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryChange From Baseline in UPCR at Week 12Baseline to Week 12Least squared mean ratio of UPCR (Urine protein g:creatinine g) compared to baseline at Week 12 in the ITT population. ITT- Intent to treat
PrimaryNumber of Participants of Treatment-emergent AEs (TEAE), TEAEs Leading to Study Withdrawal, and Serious Adverse Events (SAEs)Baseline to Week 12, and Week 12 to Week 24TEAEs leading to study withdrawal means study drug discontinuation in this endpoint.
PrimaryChange From Baseline in Activated Partial Thromboplastin TimeBaseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)Normal Range: 23.9 - 40.0
PrimaryChange From Baseline in Plasma Alanine AminotransferaseBaseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)Normal Range: 6 - 41 U/L
PrimaryChange From Baseline in Plasma Alkaline PhosphataseBaseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
PrimaryChange From Baseline in Plasma AmylaseBaseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)Normal range: 22-123 U/L
PrimaryChange From Baseline in Plasma Aspartate AminotransferaseBaseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)Normal range : 9-34 U/L
PrimaryChange From Baseline in Plasma BicarbonateBaseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)Normal range: 21-33 mmol/L
PrimaryChange From Baseline in Plasma BilirubinBaseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)Normal range: 0.1-1.10 mg/dL
PrimaryChange From Baseline in Plasma C Reactive ProteinBaseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)Normal range: 0.0-3.0 mg/L
PrimaryChange From Baseline in Plasma CalciumBaseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)Normal range: 8.5-10.5 mg/dL
PrimaryChange From Baseline in Plasma ChlorideBaseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)Normal range: 95-110 mmol/L
PrimaryChange From Baseline in Plasma CholesterolBaseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)Normal range: 100-200 mg/dL
PrimaryChange From Baseline in Plasma Creatine KinaseBaseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)Normal range: 23-210 U/L
PrimaryChange From Baseline in Plasma CreatinineBaseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)Normal range: 0.62-1.44 mg/dL
PrimaryChange From Baseline in Plasma Cystatin CBaseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)Normal range: 0.53-0.95 mg/L
PrimaryChange From Baseline in Plasma Direct BilirubinBaseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
PrimaryChange From Baseline in Plasma GlucoseBaseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)
PrimaryChange From Baseline in Plasma HDL CholesterolBaseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)HDL -High-density lipoprotein
PrimaryChange From Baseline in Plasma Indirect BilirubinBaseline to Week 12 (double-blind treatment period) and Week 12 to Week 24 (open-label extension)

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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