Trial · NCT01652872
Strategies Using Darbepoetin Alfa to Avoid Transfusions in Chronic Kidney Disease
NCT01652872, Phase 3, Completed, Amgen; results first posted 2018-11-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Strategies Using Darbepoetin Alfa to Avoid Transfusions in Chronic Kidney Disease. Trials, record NCT01652872. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01652872
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Strategies Using Darbepoetin Alfa to Avoid Transfusions in Chronic Kidney Disease
- NCT number
- NCT01652872
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 756 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Anemia in Chronic Kidney Disease Patients Not on Dialysis
- Interventions
- Darbepoetin alfa, Placebo
- First posted
- 2012-07-30
- Last updated
- 2022-09-21
- Results first posted
- 2018-11-08
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants in Receipt of 1 or More RBC Transfusions | From randomization until the end of study, up to week 101. | The percentage of participants receiving at least 1 RBC transfusion during the evaluation period was recorded for each treatment group. The evaluation period began from the date of randomization, and participants were censored at the last dose of investigational product plus 3 months or end of study, whichever was earlier (on-treatment approach). |
| Secondary | Mean Number of Units of RBC Transfused | From randomization until the end of study, up to week 101. | The total number of units of RBC transfused per participant during the evaluation period was recorded for each treatment group. The evaluation period began from the date of randomization, and participants were censored at the last dose of investigational product plus 3 months or end of study, whichever was earlier (on-treatment approach). The mean total number of RBC units transfused per participant is presented. |
| Secondary | Time to First RBC Transfusion | From randomization until the end of study, up to week 101. | Time to first RBC transfusion during the evaluation period was recorded for each treatment group. The evaluation period began from the date of randomization, and participants were censored at the last dose of investigational product plus 3 months or end of study, whichever was earlier (on-treatment approach). The time to first RBC transfusion is presented using Kaplan-Meier (KM) estimates at 6, 12, 18, and 24 months. |
| Secondary | Mean Achieved Hb Concentration While Receiving Investigational Product | From week 13 until the end of study, up to week 101. | Average achieved Hb concentration while receiving investigational product was recorded as mean Hb using the area under the curve (AUC) method for each treatment group. The AUC of Hb was calculated according to the trapezoidal method, standardized as daily AUC. Participants with available Hb values from study day 85 (week 13) to the last dose date were included in the calculation. |
| Secondary | Geometric Mean Cumulative Dose of Darbepoetin Alfa Per 4 Weeks | From randomization until the end of study, up to week 101. | Cumulative doses of darbepoetin alfa adjusted for investigation product exposure time (e.g. mean cumulative darbepoetin alfa dose per 4 weeks) were calculated for each treatment group using the total cumulative dose during the study divided by total number of weeks dosed then multiplied by 4. The geometric mean cumulative dose is presented. |
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 | Percentage of Participants in Receipt of 1 or More RBC Transfusions | From randomization until the end of study, up to week 101. | The full analysis set included all randomized participants who received at least 1 dose of investigational product. | Percentage of Participants | NUMBER |
| SECONDARY | Mean Number of Units of RBC Transfused | From randomization until the end of study, up to week 101. | The full analysis set included all randomized participants who received at least 1 dose of investigational product. | Units of transfused RBC | MEAN |
| SECONDARY | Time to First RBC Transfusion | From randomization until the end of study, up to week 101. | The full analysis set included all randomized participants who received at least 1 dose of investigational product. | Months | NUMBER |
| SECONDARY | Mean Achieved Hb Concentration While Receiving Investigational Product | From week 13 until the end of study, up to week 101. | The full analysis set included all randomized participants who received at least 1 dose of investigational product. | g/dL | MEAN |
| SECONDARY | Geometric Mean Cumulative Dose of Darbepoetin Alfa Per 4 Weeks | From randomization until the end of study, up to week 101. | The full analysis set included all randomized participants who received at least 1 dose of investigational product. | mcg | GEOMETRIC_MEAN |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants in Receipt of 1 or More RBC Transfusions | Hb-Based Titration Group | 24.40 | 95% Confidence Interval 20.07 to 28.74 | Percentage of Participants | |
| Percentage of Participants in Receipt of 1 or More RBC Transfusions | Fixed Dose Group | 24.14 | 95% Confidence Interval 19.82 to 28.46 | Percentage of Participants | |
| Mean Number of Units of RBC Transfused | Hb-Based Titration Group | 0.71 | 95% Confidence Interval 0.53 to 0.89 | Units of transfused RBC | |
| Mean Number of Units of RBC Transfused | Fixed Dose Group | 0.87 | 95% Confidence Interval 0.65 to 1.10 | Units of transfused RBC | |
| Time to First RBC Transfusion | Hb-Based Titration Group | KM estimates at month 6 | 0.115 | Months | |
| Time to First RBC Transfusion | Fixed Dose Group | KM estimates at month 6 | 0.136 | Months | |
| Time to First RBC Transfusion | Hb-Based Titration Group | KM estimates at month 12 | 0.192 | Months | |
| Time to First RBC Transfusion | Fixed Dose Group | KM estimates at month 12 | 0.204 | Months | |
| Time to First RBC Transfusion | Hb-Based Titration Group | KM estimates at month 18 | 0.261 | Months | |
| Time to First RBC Transfusion | Fixed Dose Group | KM estimates at month 18 | 0.246 | Months |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Hb-Based Titration Group | 377 | |
| Overall Study | STARTED | Fixed Dose Group | 379 | |
| Overall Study | Received Investigational Product | Hb-Based Titration Group | 377 | |
| Overall Study | Received Investigational Product | Fixed Dose Group | 377 | |
| Overall Study | COMPLETED | Hb-Based Titration Group | 232 | |
| Overall Study | COMPLETED | Fixed Dose Group | 226 | |
| Overall Study | NOT COMPLETED | Hb-Based Titration Group | 145 | |
| Overall Study | NOT COMPLETED | Fixed Dose Group | 153 |
Source ClinicalTrials.gov
Adverse events1,818
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 | Hb-Based Titration Group | 19 | 377 | |
| other | Anaemia | Blood and lymphatic system disorders | Fixed Dose Group | 36 | 377 | |
| other | Anaemia of chronic disease | Blood and lymphatic system disorders | Hb-Based Titration Group | 0 | 377 | |
| other | Anaemia of chronic disease | Blood and lymphatic system disorders | Fixed Dose Group | 1 | 377 | |
| other | Hilar lymphadenopathy | Blood and lymphatic system disorders | Hb-Based Titration Group | 1 | 377 | |
| other | Hilar lymphadenopathy | Blood and lymphatic system disorders | Fixed Dose Group | 0 | 377 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Hb-Based Titration Group | 2 | 377 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Fixed Dose Group | 4 | 377 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Hb-Based Titration Group | 3 | 377 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Fixed Dose Group | 5 | 377 |
1 to 10 of 1,818Source ClinicalTrials.gov
See all 1,818 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Hb-Based Titration Group | 38 | 377 |
| Total, all-cause mortality | Fixed Dose Group | 38 | 377 |
| Total, other adverse events | Hb-Based Titration Group | 292 | 377 |
| Total, other adverse events | Fixed Dose Group | 300 | 377 |
| Total, serious adverse events | Hb-Based Titration Group | 190 | 377 |
| Total, serious adverse events | Fixed Dose Group | 175 | 377 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33288629 | BACKGROUND |
Source PubMed
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Hb-Based Titration Group vs Fixed Dose Group: deaths from any cause | Trial comparisons |
| Hb-Based Titration Group vs Fixed Dose Group: 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/NCT01652872
GET https://conductscience.org/api/trials/v1/NCT01652872/events?page=2