Comparison · NCT02855268-077e7cd6
DB Period: Lademirsen vs DB Period: Placebo: DB Period: Number of Participants Who Developed End Stage Renal Disease (ESRD)
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. DB Period: Lademirsen vs DB Period: Placebo: DB Period: Number of Participants Who Developed End Stage Renal Disease (ESRD). Trial comparisons, record NCT02855268-077e7cd6. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02855268-077e7cd6
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.0345 | 0.00611 | 0.172 | wilson | |
| Risk in group 2 | 0 | 0.0000000000000000139 | 0.215 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0345 | -0.183 | 0.172 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat, for one more participant with the outcome on DB Period: Lademirsen than on DB Period: Placebo | 29 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | DB Period: Lademirsen | Participants received SC doses of lademirsen 110 mg QW during the 48 weeks of DB treatment period. | 1 | 29 | OG001 |
| Group 2 | DB Period: Placebo | Participants received SC doses of placebo (matched to lademirsen) QW during the 48 weeks of DB treatment period. | 0 | 14 | OG000 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- DB Period: Number of Participants Who Developed End Stage Renal Disease (ESRD)
- Description
- ESRD was defined as: eGFR \<=15 mL/min/1.73 m\^2; or initiation of hemodialysis; or receiving a renal transplantation during the double-blind treatment period.
- Time frame
- From Baseline up to Week 48
- Population
- Analysis was performed on ITT population.
Source ClinicalTrials.gov
Trial
- Title
- Study of Lademirsen (SAR339375) in Patients With Alport Syndrome
- NCT number
- NCT02855268
- Phases
- PHASE2
- Conditions
- Alport Syndrome
- Interventions
- lademirsen (SAR339375), Placebo
- Lead sponsor
- Genzyme, a Sanofi Company
- Results first posted
- 2023-10-23
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02855268?tab=results
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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