Comparison · NCT01858532-ccda25f3
Intent-to-Treat (ITT) Responder Atrasentan vs Intent-to-Treat (ITT) Responder Placebo: Time to Cardio-renal Composite 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 Cardio-renal Composite Endpoint in the Intent-to-Treat (ITT) Responder Set (as Randomized). Trial comparisons, record NCT01858532-ccda25f3. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01858532-ccda25f3
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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 | 0.111 | 0.0951 | 0.129 | wilson | |
| Risk in group 2 | 0.13 | 0.113 | 0.149 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0191 | -0.0439 | 0.00577 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.853 | 0.694 | 1.05 | log | |
| Odds ratio, group 1 over group 2 | 0.835 | 0.66 | 1.06 | 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 | 52.5 | 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 | 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 | 147 | 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 | 172 | 1,323 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Time to Cardio-renal Composite Endpoint in the Intent-to-Treat (ITT) Responder Set (as Randomized)
- Description
The composite event of interest for this outcome consisted of doubling of serum creatinine, end-stage renal disease (ESRD), cardiovascular (CV) death (including CV death and presumed CV death), nonfatal myocardial infarction (MI; heart attack) and nonfatal stroke. Presumed sudden cardiac death was included as a subcategory of presumed CV 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 cardio-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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