Comparison · NCT01858532-526046c6
Intent-to-Treat (ITT) Responder Atrasentan vs Intent-to-Treat (ITT) Responder Placebo: Time to the First Occurrence of a Component of the Composite Renal Endpoint in the Intent-to-Treat (ITT) Responder Set (as Randomized)
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) Responder Atrasentan vs Intent-to-Treat (ITT) Responder Placebo: Time to the First Occurrence of a Component of the Composite Renal Endpoint in the Intent-to-Treat (ITT) Responder Set (as Randomized). Trial comparisons, record NCT01858532-526046c6. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01858532-526046c6
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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 | 0.0596 | 0.0481 | 0.0737 | wilson | |
| Risk in group 2 | 0.0794 | 0.066 | 0.0952 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0197 | -0.0393 | -0.00033 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.751 | 0.567 | 0.996 | log | |
| Odds ratio, group 1 over group 2 | 0.735 | 0.544 | 0.995 | log | |
| Number needed to treat, for one fewer participant with the outcome on Intent-to-Treat (ITT) Responder Atrasentan than on Intent-to-Treat (ITT) Responder Placebo | 50.7 | 25.4 | 3,030 | 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) Responder Atrasentan | Participants who achieved at least 30% reduction in their albumin to creatinine ratio (UACR) in the Enrichment Period and were randomized to receive atrasentan in the Double-Blind Treatment Period | 79 | 1,325 | OG000 |
| Group 2 | Intent-to-Treat (ITT) Responder Placebo | Participants who achieved at least 30% reduction in their albumin to creatinine ratio (UACR) in the Enrichment Period and were randomized to receive placebo in the Double-Blind Treatment Period | 105 | 1,323 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Time to the First Occurrence of a Component of the Composite Renal Endpoint in the Intent-to-Treat (ITT) Responder Set (as Randomized)
- 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). Only events adjudicated by the Events Adjudication Committee (EAC) were considered in defining this endpoint. Data are presented as number of participants with a primary renal composite event (first event per participant).
- Time frame
- From randomization to individual end of observation, up to 53 months
- Population
- Intent-to-Treat (ITT) Responders (participants who achieved at least 30% reduction in their albumin to creatinine ratio \[UACR\] in the Enrichment Period \[EP\])
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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