Trial · NCT01858532
Study Of Diabetic Nephropathy With Atrasentan
NCT01858532, Phase 3, Terminated, AbbVie; results first posted 2019-04-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study Of Diabetic Nephropathy With Atrasentan. Trials, record NCT01858532. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01858532
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study Of Diabetic Nephropathy With Atrasentan
- NCT number
- NCT01858532
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 5,107 participants, actual
- Lead sponsor
- AbbVie
- Conditions
- Diabetic Nephropathy
- Interventions
- Atrasentan, Placebo
- First posted
- 2013-05-21
- Last updated
- 2019-04-24
- Other registries' IDs
- eudract:2012-005848-21
- Results first posted
- 2019-04-24
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to the First Occurrence of a Component of the Composite Renal Endpoint in the Intent-to-Treat (ITT) Responder Set (as Randomized) | From randomization to individual end of observation, up to 53 months | 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). |
| Secondary | Time to a 50% Estimated Glomerular Filtration Rate Reduction in the Intent-to-Treat (ITT) Responder Set (as Randomized) | From randomization to individual end of observation, up to 53 months | The event of interest for this outcome was a 50% reduction in a participant's estimated glomerular filtration rate (eGFR) value as compared to baseline, confirmed by a repeated value at least 20 days apart. The event time was defined as the first time that a 50% reduction in eGFR was observed. Data are presented as number of participants with a 50% reduction in eGFR (first event per participant). |
| Secondary | Time to Cardio-renal Composite Endpoint in the Intent-to-Treat (ITT) Responder Set (as Randomized) | From randomization to individual end of observation, up to 53 months | 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). |
| Secondary | Time to First Occurrence of a Component of Composite Renal Endpoint for All Randomized Participants (Pooled) | From randomization to individual end of observation, up to 53 months | 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). |
| Secondary | Time to the Cardiovascular Composite Endpoint in the Intent-to-Treat (ITT) Responder Set (as Randomized) | From randomization to individual end of observation, up to 53 months | The composite event of interest for this outcome was cardiovascular (CV) death (CV death, presumed CV death), nonfatal myocardial infarction (MI; heart attack), and nonfatal stroke. Presumed sudden cardiac death was included as a sub-category of presumed CV death. Only events adjudicated by the Events Adjudication Committee (EAC) were used. Data are presented as number of participants with a cardiovascular composite event (first event per participant). |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to the First Occurrence of a Component of the Composite Renal Endpoint in the Intent-to-Treat (ITT) Responder Set (as Randomized) | From randomization to individual end of observation, up to 53 months | Intent-to-Treat (ITT) Responders (participants who achieved at least 30% reduction in their albumin to creatinine ratio \[UACR\] in the Enrichment Period \[EP\]) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to a 50% Estimated Glomerular Filtration Rate Reduction in the Intent-to-Treat (ITT) Responder Set (as Randomized) | From randomization to individual end of observation, up to 53 months | Intent-to-Treat (ITT) Responders (participants who achieved at least 30% reduction in their albumin to creatinine ratio \[UACR\] in the Enrichment Period \[EP\]) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Cardio-renal Composite Endpoint in the Intent-to-Treat (ITT) Responder Set (as Randomized) | From randomization to individual end of observation, up to 53 months | Intent-to-Treat (ITT) Responders (participants who achieved at least 30% reduction in their albumin to creatinine ratio \[UACR\] in the Enrichment Period \[EP\]) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to First Occurrence of a Component of Composite Renal Endpoint for All Randomized Participants (Pooled) | From randomization to individual end of observation, up to 53 months | Intent-to-treat population: participants who were randomized to receive either atrasentan or placebo during the Double-Blind Treatment Period | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to the Cardiovascular Composite Endpoint in the Intent-to-Treat (ITT) Responder Set (as Randomized) | From randomization to individual end of observation, up to 53 months | Intent-to-Treat (ITT) Responders (participants who achieved at least 30% reduction in their albumin to creatinine ratio \[UACR\] in the Enrichment Period \[EP\]) | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to the First Occurrence of a Component of the Composite Renal Endpoint in the Intent-to-Treat (ITT) Responder Set (as Randomized) | Intent-to-Treat (ITT) Responder Atrasentan | 79 | Participants | ||
| Time to the First Occurrence of a Component of the Composite Renal Endpoint in the Intent-to-Treat (ITT) Responder Set (as Randomized) | Intent-to-Treat (ITT) Responder Placebo | 105 | Participants | ||
| Time to a 50% Estimated Glomerular Filtration Rate Reduction in the Intent-to-Treat (ITT) Responder Set (as Randomized) | Intent-to-Treat (ITT) Responder Atrasentan | 78 | Participants | ||
| Time to a 50% Estimated Glomerular Filtration Rate Reduction in the Intent-to-Treat (ITT) Responder Set (as Randomized) | Intent-to-Treat (ITT) Responder Placebo | 88 | Participants | ||
| Time to Cardio-renal Composite Endpoint in the Intent-to-Treat (ITT) Responder Set (as Randomized) | Intent-to-Treat (ITT) Responder Atrasentan | 147 | Participants | ||
| Time to Cardio-renal Composite Endpoint in the Intent-to-Treat (ITT) Responder Set (as Randomized) | Intent-to-Treat (ITT) Responder Placebo | 172 | Participants | ||
| Time to First Occurrence of a Component of Composite Renal Endpoint for All Randomized Participants (Pooled) | Intent-to-Treat (ITT) Atrasentan | 152 | Participants | ||
| Time to First Occurrence of a Component of Composite Renal Endpoint for All Randomized Participants (Pooled) | Intent-to-Treat Placebo | 192 | Participants | ||
| Time to the Cardiovascular Composite Endpoint in the Intent-to-Treat (ITT) Responder Set (as Randomized) | Intent-to-Treat (ITT) Responder Atrasentan | 72 | Participants | ||
| Time to the Cardiovascular Composite Endpoint in the Intent-to-Treat (ITT) Responder Set (as Randomized) | Intent-to-Treat (ITT) Responder Placebo | 81 | Participants |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Intent-to-Treat (ITT) Responder Atrasentan | 1,325 | |
| Overall Study | STARTED | Intent-to-Treat (ITT) Responder Placebo | 1,323 | |
| Overall Study | STARTED | Intent-to-Treat (ITT) Non-responder Atrasentan | 509 | |
| Overall Study | STARTED | Intent-to-Treat (ITT) Non-responder Placebo | 511 | |
| Overall Study | COMPLETED | Intent-to-Treat (ITT) Responder Atrasentan | 1,144 | |
| Overall Study | COMPLETED | Intent-to-Treat (ITT) Responder Placebo | 1,131 | |
| Overall Study | COMPLETED | Intent-to-Treat (ITT) Non-responder Atrasentan | 411 | |
| Overall Study | COMPLETED | Intent-to-Treat (ITT) Non-responder Placebo | 418 | |
| Overall Study | NOT COMPLETED | Intent-to-Treat (ITT) Responder Atrasentan | 181 | |
| Overall Study | NOT COMPLETED | Intent-to-Treat (ITT) Responder Placebo | 192 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events2,394
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | ANAEMIA | Blood and lymphatic system disorders | Enrichment Atrasentan | 180 | 5,107 | 183 |
| other | ANAEMIA | Blood and lymphatic system disorders | Double-Blind Atrasentan | 216 | 1,829 | 241 |
| other | ANAEMIA | Blood and lymphatic system disorders | Double-Blind Placebo | 127 | 1,830 | 138 |
| other | DIARRHOEA | Gastrointestinal disorders | Enrichment Atrasentan | 103 | 5,107 | 108 |
| other | DIARRHOEA | Gastrointestinal disorders | Double-Blind Atrasentan | 99 | 1,829 | 116 |
| other | DIARRHOEA | Gastrointestinal disorders | Double-Blind Placebo | 103 | 1,830 | 110 |
| other | OEDEMA PERIPHERAL | General disorders | Enrichment Atrasentan | 1,148 | 5,107 | 1,273 |
| other | OEDEMA PERIPHERAL | General disorders | Double-Blind Atrasentan | 534 | 1,829 | 765 |
| other | OEDEMA PERIPHERAL | General disorders | Double-Blind Placebo | 483 | 1,830 | 666 |
| other | NASOPHARYNGITIS | Infections and infestations | Enrichment Atrasentan | 145 | 5,107 | 152 |
1 to 10 of 2,394Source ClinicalTrials.gov
See all 2,394 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Enrichment Atrasentan | 25 | 5,107 |
| Total, all-cause mortality | Double-Blind Atrasentan | 84 | 1,829 |
| Total, all-cause mortality | Double-Blind Placebo | 79 | 1,830 |
| Total, other adverse events | Enrichment Atrasentan | 1,781 | 5,107 |
| Total, other adverse events | Double-Blind Atrasentan | 1,043 | 1,829 |
| Total, other adverse events | Double-Blind Placebo | 1,038 | 1,830 |
| Total, serious adverse events | Enrichment Atrasentan | 292 | 5,107 |
| Total, serious adverse events | Double-Blind Atrasentan | 685 | 1,829 |
| Total, serious adverse events | Double-Blind Placebo | 626 | 1,830 |
Source ClinicalTrials.gov
Papers9
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
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 |
Intent-to-Treat (ITT) Responder Atrasentan vs Intent-to-Treat (ITT) Responder Placebo: Time to a 50% Estimated Glomerular Filtration Rate Reduction in the Intent-to-Treat (ITT) Responder Set (as Randomized) | Trial comparisons |
| 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 |
| Intent-to-Treat (ITT) Responder Atrasentan vs Intent-to-Treat (ITT) Responder Placebo: Time to the Cardiovascular Composite Endpoint in the Intent-to-Treat (ITT) Responder Set (as Randomized) | Trial comparisons |
| 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 |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01858532
GET https://conductscience.org/api/trials/v1/NCT01858532/events?page=2