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Comparison · NCT03806452-b4611a79

Hydroxycarbamide vs Placebo: Number of Patients Achieving at Least a 30% Decrease in ACR Baseline Value

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. Hydroxycarbamide vs Placebo: Number of Patients Achieving at Least a 30% Decrease in ACR Baseline Value. Trial comparisons, record NCT03806452-b4611a79. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03806452-b4611a79

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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 10.4190.2840.567wilson
Risk in group 20.3950.2560.553wilson
Risk difference, group 1 minus group 20.0239-0.1840.227newcombe hybrid score
Risk ratio, group 1 over group 21.060.6251.8log
Odds ratio, group 1 over group 21.10.4542.69log
Number needed to treat, for one more participant with the outcome on Hydroxycarbamide than on Placebo41.9from the risk difference intervalthe interval includes no difference

Groups2

Group 2 names the comparator: placebo.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Hydroxycarbamide
Hydroxycarbamide will be supplied as 100 mg or 1000 mg film-coated tablets. The posology will be based on the patient's body weight (bw). Hydroxycarbamide will be prescribed at a dose of 15 mg/kg bw/day and will be adminitered for 6 months.~Hydroxycarbamide will be administered for 12 months for patients qualified as responders willing to continue to participate in the trial.~Hydroxycarbamide: Hydroxycarbamide tablets of 100 and 1000 mg
1843OG000
Group 2Placebo
Placebo will be supplied as 100 mg or 1000 mg film-coated tablets. The posology will be based on the patient's body weight (bw). Placebo will be prescribed at a dose of 15 mg/kg bw/day and will be adminitered for 6 months.~Hydroxycarbamide will be administered for 12 months for patients qualified as responders willing to continue to participate in the trial.~Placebo Oral Tablet: Placebo tablets of 100 and 1000 mg to mimic hydroxycarbamide tablets
1538OG001

Outcome

Type
PRIMARY
Title
Number of Patients Achieving at Least a 30% Decrease in ACR Baseline Value
Description
The primary endpoint of this study is the proportion of patients in the hydroxycarbamide and placebo groups achieving at least a 30% decrease in ACR baseline value at 6 months after treatment initiation. Patients who do not achieve at least a 30% decrease of the ACR baseline value at month 6 will be considered non-responders.
Time frame
6 months
Population
3 patients in the hydroxycarbamide arm and 2 patients in the placebo arm do not have any measure at 6 months and so were not part of this analysis

Source ClinicalTrials.gov

Trial

Title
SIKAMIC (SIklos on Kidney Function and AlbuMInuria Clinical Trial)
NCT number
NCT03806452
Phases
PHASE2
Conditions
Sickle Cell Disease
Interventions
Hydroxycarbamide, Placebo Oral Tablet
Lead sponsor
Theravia
Results first posted
2025-05-14

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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