Comparison · NCT01858532-d8fa2d4b
Intent-to-Treat (ITT) Atrasentan vs Intent-to-Treat Placebo: Time to First Occurrence of a Component of Composite Renal Endpoint for All Randomized Participants (Pooled)
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. Intent-to-Treat (ITT) Atrasentan vs Intent-to-Treat Placebo: Time to First Occurrence of a Component of Composite Renal Endpoint for All Randomized Participants (Pooled). Trial comparisons, record NCT01858532-d8fa2d4b. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01858532-d8fa2d4b
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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 | 0.0829 | 0.0711 | 0.0964 | wilson | |
| Risk in group 2 | 0.105 | 0.0915 | 0.12 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0218 | -0.0408 | -0.00293 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.792 | 0.646 | 0.97 | log | |
| Odds ratio, group 1 over group 2 | 0.773 | 0.618 | 0.966 | log | |
| Number needed to treat, for one fewer participant with the outcome on Intent-to-Treat (ITT) Atrasentan than on Intent-to-Treat Placebo | 45.9 | 24.5 | 342 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Intent-to-Treat (ITT) Atrasentan | All randomized participants who entered the Double-Blind Treatment Period and were randomized to receive atrasentan | 152 | 1,834 | OG000 |
| Group 2 | Intent-to-Treat Placebo | All randomized participants who entered the Double-Blind Treatment Period and were randomized to receive placebo | 192 | 1,834 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Time to First Occurrence of a Component of Composite Renal Endpoint for All Randomized Participants (Pooled)
- Description
Time to the first occurrence of a component of the composite renal endpoint was defined as doubling of serum creatinine (confirmed by a 30-day serum creatinine measurement) or the onset of end stage renal disease (estimated glomerular filtration rate \[eGFR\] less than 15 ml/min/1.73 m\^2 confirmed by a 90-day eGFR measurement, receiving chronic dialysis, renal transplantation, or renal death). Data for all randomized participants were pooled by treatment and analyzed. Data are presented as number of participants with a renal composite event (first event per participant).
- Time frame
- From randomization to individual end of observation, up to 53 months
- Population
- Intent-to-treat population: participants who were randomized to receive either atrasentan or placebo during the Double-Blind Treatment Period
Source ClinicalTrials.gov
Trial
- Title
- Study Of Diabetic Nephropathy With Atrasentan
- NCT number
- NCT01858532
- Phases
- PHASE3
- Conditions
- Diabetic Nephropathy
- Interventions
- Atrasentan, Placebo
- Lead sponsor
- AbbVie
- Results first posted
- 2019-04-24
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01858532?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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