Trial · NCT00093015
Trial to Reduce Cardiovascular Events With Aranesp® Therapy (TREAT)
NCT00093015, Phase 3, Completed, Amgen; results first posted 2010-09-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Trial to Reduce Cardiovascular Events With Aranesp® Therapy (TREAT). Trials, record NCT00093015. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00093015
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial to Reduce Cardiovascular Events With Aranesp® Therapy (TREAT)
- NCT number
- NCT00093015
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 4,038 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Kidney Disease, Diabetes Mellitus, Anemia
- Interventions
- Placebo, darbepoetin alfa
- First posted
- 2004-09-29
- Last updated
- 2022-11-08
- Results first posted
- 2010-09-02
- Limitations and caveats
4047 subjects were enrolled, but before unblinding, all information from 9 subjects was excluded from two sites (3 and 6 subjects, respectively) that did not adhere to Good Clinical Practice guidelines. 4038 subjects were analyzed and reported.
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to All-cause Mortality or Cardiovascular (CV) Events Including Hospitalization Due to Acute Myocardial Ischemia, Congestive Heart Failure (CHF), Myocardial Infarction (MI), and Cerebrovascular Accident (CVA) | Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first | Time from randomization to the first confirmed composite event. Kaplan-Meier estimate of the median time was not estimable due to low proportion of participants experiencing at least one events, therefore participants experiencing at least one event were summarized. |
| Primary | Time to All-cause Mortality or End Stage Renal Disease (ESRD) | Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first | Time from randomization to first event of all-cause mortality or ESRD. Kaplan-Meier estimate of the median time was not estimable due to low proportion of participants experiencing at least one events, therefore participants experiencing at least one event were summarized. |
| Secondary | Time to All-cause Mortality | Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first | Time from randomization to all-cause mortality. Kaplan-Meier estimate of the median time was not estimable due to low proportion of participants experiencing at least one events, therefore participants experiencing at least one event were summarized. |
| Secondary | Time to Cardiovascular Mortality | Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first | Time from randomization to cardiovascular (CV) mortality. Kaplan-Meier estimate of the median time was not estimable due to low proportion of participants experiencing at least one events, therefore participants experiencing at least one event were summarized. |
| Secondary | Time to Myocardial Infarction | Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first | Time from randomization to fatal or non-fatal myocardial infarction (MI). Kaplan-Meier estimate of the median time was not estimable due to low proportion of participants experiencing at least one events, therefore participants experiencing at least one event were summarized. |
| Secondary | Time to Cerebrovascular Accident | Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first | Time from randomization to fatal or non-fatal cerebrovascular accident (CVA). Kaplan-Meier estimate of the median time was not estimable due to low proportion of participants experiencing at least one events, therefore participants experiencing at least one event were summarized. |
| Secondary | Time to Congestive Heart Failure | Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first | Time from randomization to fatal or non-fatal congestive heart failure(CHF). Kaplan-Meier estimate of the median time was not estimable due to low proportion of participants experiencing at least one events, therefore participants experiencing at least one event were summarized. |
| Secondary | Time to End Stage Renal Disease | Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first | Time from randomization to end stage renal disease (ESRD). Kaplan-Meier estimate of the median time was not estimable due to low proportion of participants experiencing at least one events, therefore participants experiencing at least one event were summarized. |
| Secondary | Rate of Decline in Estimated Glomerular Filtration Rate (eGFR) Relative to Baseline | Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first | GFR was estimated using the following MDRD formula: 186 x \[Serum creatinine\]\^(-1.154) x \[Age\]\^(-0.203) x \[0.742 if subject is female\] x \[1.210 if subject is black\]. Change from baseline in eGFR at week 49 for each treatment group are presented. The treatment effect of the rate of decline in eGFR per year was estimated using the mixed model. |
| Secondary | Change in Patient Reported Fatigue Relative to Baseline at Week 25 | Baseline and week 25 | Change in patient reported fatigue measured by the Functional Assessment of Cancer Therapy (FACT) - Fatigue scale from baseline to week 25. Range and direction of scale: 0 = most fatigue; 52 = least fatigue |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to All-cause Mortality or Cardiovascular (CV) Events Including Hospitalization Due to Acute Myocardial Ischemia, Congestive Heart Failure (CHF), Myocardial Infarction (MI), and Cerebrovascular Accident (CVA) | Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first | The analysis followed intent-to-treat principles. Subjects were analyzed as randomized using all available follow-up information. | Participants | NUMBER |
| PRIMARY | Time to All-cause Mortality or End Stage Renal Disease (ESRD) | Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first | The analysis followed intent-to-treat principles. Subjects were analyzed as randomized using all available follow-up information. | Participants | NUMBER |
| SECONDARY | Time to All-cause Mortality | Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first | The analysis followed intent-to-treat principles. Subjects were analyzed as randomized using all available follow-up information. | Participants | NUMBER |
| SECONDARY | Time to Cardiovascular Mortality | Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first | The analysis followed intent-to-treat principles. Subjects were analyzed as randomized using all available follow-up information. | Participants | NUMBER |
| SECONDARY | Time to Myocardial Infarction | Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first | The analysis followed intent-to-treat principles. Subjects were analyzed as randomized using all available follow-up information. | Participants | NUMBER |
| SECONDARY | Time to Cerebrovascular Accident | Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first | The analysis followed intent-to-treat principles. Subjects were analyzed as randomized using all available follow-up information. | Participants | NUMBER |
| SECONDARY | Time to Congestive Heart Failure | Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first | The analysis followed intent-to-treat principles. Subjects were analyzed as randomized using all available follow-up information. | Participants | NUMBER |
| SECONDARY | Time to End Stage Renal Disease | Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first | The analysis followed intent-to-treat principles. Subjects were analyzed as randomized using all available follow-up information. | Participants | NUMBER |
| SECONDARY | Rate of Decline in Estimated Glomerular Filtration Rate (eGFR) Relative to Baseline | Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first | Subjects were analyzed as randomized using all available eGFR measurements, except eGFR measurements measured after subjects develop ESRD since creatinine measurements were no longer reliable or meaningful for eGFR calculation. | mL/min/1.73m^2 | MEAN |
| SECONDARY | Change in Patient Reported Fatigue Relative to Baseline at Week 25 | Baseline and week 25 | Subjects with both the baseline and at least post-baseline measurement at week 25 for FACT-fatigue were included in the analysis and were analyzed as randomized. Last observation carried forward (LOCF) using last non-missing post-baseline value was used for missing post-baseline data for subjects who were still on study. | Units on a scale | MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Time to All-cause Mortality or Cardiovascular (CV) Events Including Hospitalization Due to Acute Myocardial Ischemia, Congestive Heart Failure (CHF), Myocardial Infarction (MI), and Cerebrovascular Accident (CVA) | Placebo | 602 | Participants | ||
Time to All-cause Mortality or Cardiovascular (CV) Events Including Hospitalization Due to Acute Myocardial Ischemia, Congestive Heart Failure (CHF), Myocardial Infarction (MI), and Cerebrovascular Accident (CVA) | Darbepoetin Alfa | 632 | Participants | ||
| Time to All-cause Mortality or End Stage Renal Disease (ESRD) | Placebo | 618 | Participants | ||
| Time to All-cause Mortality or End Stage Renal Disease (ESRD) | Darbepoetin Alfa | 652 | Participants | ||
| Time to All-cause Mortality | Placebo | 395 | Participants | ||
| Time to All-cause Mortality | Darbepoetin Alfa | 412 | Participants | ||
| Time to Cardiovascular Mortality | Placebo | 250 | Participants | ||
| Time to Cardiovascular Mortality | Darbepoetin Alfa | 259 | Participants | ||
| Time to Myocardial Infarction | Placebo | 129 | Participants | ||
| Time to Myocardial Infarction | Darbepoetin Alfa | 124 | Participants |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 2,026 | |
| Overall Study | STARTED | Darbepoetin Alfa | 2,012 | |
| Overall Study | Received Study Medication | Placebo | 2,019 | |
| Overall Study | Received Study Medication | Darbepoetin Alfa | 2,004 | |
| Overall Study | COMPLETED | Placebo | 1,361 | |
| Overall Study | COMPLETED | Darbepoetin Alfa | 1,348 | |
| Overall Study | NOT COMPLETED | Placebo | 665 | |
| Overall Study | NOT COMPLETED | Darbepoetin Alfa | 664 |
Source ClinicalTrials.gov
Adverse events1,980
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 | Placebo | 102 | 2,019 | |
| other | Anaemia | Blood and lymphatic system disorders | Darbepoetin Alfa | 57 | 2,004 | |
| other | Constipation | Gastrointestinal disorders | Placebo | 154 | 2,019 | |
| other | Constipation | Gastrointestinal disorders | Darbepoetin Alfa | 130 | 2,004 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 283 | 2,019 | |
| other | Diarrhoea | Gastrointestinal disorders | Darbepoetin Alfa | 279 | 2,004 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 227 | 2,019 | |
| other | Nausea | Gastrointestinal disorders | Darbepoetin Alfa | 231 | 2,004 | |
| other | Vomiting | Gastrointestinal disorders | Placebo | 190 | 2,019 | |
| other | Vomiting | Gastrointestinal disorders | Darbepoetin Alfa | 200 | 2,004 |
1 to 10 of 1,980Source ClinicalTrials.gov
See all 1,980 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Darbepoetin Alfa | ||
| Total, other adverse events | Placebo | 1,547 | 2,019 |
| Total, other adverse events | Darbepoetin Alfa | 1,571 | 2,004 |
| Total, serious adverse events | Placebo | 1,219 | 2,019 |
| Total, serious adverse events | Darbepoetin Alfa | 1,235 | 2,004 |
Source ClinicalTrials.gov
Papers12
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 comparisons10
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Darbepoetin Alfa vs Placebo: Time to Cardiovascular Mortality | Trial comparisons |
| Darbepoetin Alfa vs Placebo: Time to Cerebrovascular Accident | Trial comparisons |
Darbepoetin Alfa vs Placebo: Time to All-cause Mortality or Cardiovascular (CV) Events Including Hospitalization Due to Acute Myocardial Ischemia, Congestive Heart Failure (CHF), Myocardial Infarction (MI), and Cerebrovascular Accident (CVA) | Trial comparisons |
| Darbepoetin Alfa vs Placebo: Time to Congestive Heart Failure | Trial comparisons |
| Darbepoetin Alfa vs Placebo: Time to Myocardial Infarction | Trial comparisons |
| Darbepoetin Alfa vs Placebo: Time to All-cause Mortality | Trial comparisons |
| Darbepoetin Alfa vs Placebo: Time to Hospitalization Due to Acute Myocardial Ischemia | Trial comparisons |
| Darbepoetin Alfa vs Placebo: Time to All-cause Mortality or End Stage Renal Disease (ESRD) | Trial comparisons |
| Darbepoetin Alfa vs Placebo: Time to End Stage Renal Disease | Trial comparisons |
| Darbepoetin Alfa vs Placebo: serious adverse events | 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/NCT00093015
GET https://conductscience.org/api/trials/v1/NCT00093015/results?page=2