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Comparison · NCT05306873-36ddeea4

Stage 3 MMF + Voclosporin vs Stage 3 MMF + Placebo for Voclosporin: The Incidence of Grade 3 or Higher Hypertension in Stage 3

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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ConductScience Library. Stage 3 MMF + Voclosporin vs Stage 3 MMF + Placebo for Voclosporin: The Incidence of Grade 3 or Higher Hypertension in Stage 3. Trial comparisons, record NCT05306873-36ddeea4. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT05306873-36ddeea4

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 1000.658wilson
Risk in group 2000.793wilson
Risk difference, group 1 minus group 20-0.7930.658newcombe hybrid score
Risk ratio, group 1 over group 2loga group has no participants with the outcome
Odds ratio, group 1 over group 2loga cell of the two-by-two table is zero
Number needed to treatfrom the risk difference intervalthe two groups' risks are equal

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Stage 3 MMF + Voclosporin
Participants receive up to 24 weeks MMF plus 23.7 mg voclosporin (3 x 7.9 mg capsules) twice daily. Participants who previously received placebo in Stage 2 receive a scheduled ramp-up of MMF for the first two weeks.~Participants who received placebo in Stage 2:~* Week 1: participants receive 500 mg MMF plus matching MMF placebo (to appear like a 1000mg dose) twice daily~* Week 2: participants receive 500 mg plus matching placebo for MMF (to appear like a 1000 mg dose) and 1000 mg MMF in divided doses~* Weeks 3-24: 1000 mg MMF twice daily~Participants who receive MMF in Stage 2:~• Weeks 1-24: 1000 mg MMF twice daily
02OG000
Group 2Stage 3 MMF + Placebo for Voclosporin
Participants receive up to 24 weeks MMF plus 23.7 mg voclosporin placebo (3 x 7.9 mg capsules) twice daily. Participants who previously received placebo in Stage 2 receive a scheduled ramp-up of MMF for the first two weeks.~Participants who received placebo in Stage 2:~* Week 1: participants receive 500 mg MMF plus matching MMF placebo (to appear like a 1000mg dose) twice daily~* Week 2: participants receive 500 mg plus matching placebo for MMF (to appear like a 1000 mg dose) and 1000 mg MMF in divided doses~* Weeks 3-24: 1000 mg MMF twice daily~Participants who received MMF in Stage 2:~• Weeks 1-24: 1000 mg MMF twice daily
01OG001

Outcome

Type
SECONDARY
Title
The Incidence of Grade 3 or Higher Hypertension in Stage 3
Description
Defined as a systolic blood pressure \>= 160 mm Hg or a diastolic blood pressure of \>= 100 mm Hg
Time frame
After Stage 3 re-randomization Day 0 to Stage 3 Week 24
Population
Includes participants who received at least one dose Stage 3 study drug.

Source ClinicalTrials.gov

Trial

Title
Examining Distinct Immunophenotypes to Validate and Enhance Rational Treatment in Systemic Lupus
NCT number
NCT05306873
Phases
PHASE2
Conditions
Systemic Lupus Erythematosus
Interventions
Mycophenolate Mofetil, Placebo for Mycophenolate Mofetil, Voclosporin, Placebo for Voclosporin, Mycophenolate Mofetil
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Results first posted
2025-09-09

Source ClinicalTrials.gov

Source

Release
trial-comparisons-2026-03-23-0.1.0
Release manifest SHA-256
f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
AACT copy
2026-03-23
Tables read
outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet

Source ClinicalTrials.gov

Sources 2

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

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.

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