A Phase 3 interventional study of Darbepoetin alfa and Placebo in Heart Failure, Anemia and Cardiovascular Disease, sponsored by Amgen. Completed at 754 sites in 36 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-08.
Sponsored by Amgen · Phase 3, Interventional, and Treatment
The purpose of the study is to determine the efficacy of treatment of anemia with darbepoetin alfa compared to placebo on the composite of time to death from any cause or first hospital admission for worsening heart failure in patients with symptomatic left ventricular systolic dysfunction and anemia.
Several epidemiological studies have demonstrated an association between HF and anemia and correlation of increased risk for mortality and hospitalization with low hemoglobin in patients with HF. Earlier single-center interventional studies suggest that meaningful clinical benefits may be achieved by raising hemoglobin concentration in patients with symptomatic HF and anemia. Data from Amgen's completed phase 2 multi-center studies support this hypothesis and show that darbepoetin alfa is well tolerated in patients with symptomatic left ventricular systolic dysfunction and anemia and effectively raises hemoglobin. The pivotal phase 3 Study 20050222 RED-HF Trial is evaluating the effect of treatment with darbepoetin alfa on the composite risk of all-cause mortality or hospitalization for worsening HF in patients with symptomatic left ventricular systolic dysfunction and anemia. This study also evaluates the effect of darbepoetin alfa treatment on all-cause death, on cardiovascular death or hospitalization for worsening HF, and on patient-reported quality-of-life outcomes.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 2,278 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Amgen is the lead sponsor of 1,015 studies on the registry; 49 are open to participants now.
Of its 245 completed or terminated interventional studies of FDA-regulated products, 159 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Starting dose of 0.75 µg/kg subcutaneously every 2 weeks until hemoglobin concentrations reach 13.0 g/dL on 2 consecutive visits, then monthly dosing, titrated to achieve hemoglobin target of 13.0 g/dL, not to exceed 14.5 g/dL.
Drug: Darbepoetin alfa
Participants received dose and administration schedule (every 2 weeks or once a month) changes that simulated the changes for participants receiving darbepoetin alfa.
Drug: Placebo
Administered by subcutaneous injection
Also known as: Aranesp®
Placebo subcutaneous injection
Time to All Cause Death or First Hospitalization for Worsening Heart Failure
Time to death from any cause or first hospital admission for worsening heart failure (adjudicated by the Clinical Endpoint Committee), whichever occurred first, estimated by Kaplan-Meier method. Participants not experiencing a qualifying event during the study were censored at their last contact time or the study termination date, whichever occurred first.
Time frame: From randomization to the end of study; maximum time on study was 73 months
Time to Death From Any Cause
Time from randomization to death due to any cause, estimated by the Kaplan-Meier method. Participants not experiencing a qualifying event during the study were censored at their last contact time or the study termination date, whichever occurred first.
Time frame: From randomization to the end of study; maximum time on study was 73 months
Time to Cardiovascular Death or First Hospital Admission for Worsening Heart Failure
Time to cardiovascular death or first hospital admission for worsening heart failure, whichever occured first, estimated using the Kaplan Meier method. Participants not experiencing a qualifying event during the study were censored at their last contact time or the study termination date, whichever occurred first.
Time frame: From randomization to the end of study; maximum time on study was 73 months
Change From Baseline to Month 6 in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score
The KCCQ is a disease-specific patient-reported outcomes measure for patients with heart failure. It consists of 23 items, is comprised of 7 clinically relevant scales (Symptom Frequency, Symptom Burden, Symptom Stability, Physical Limitation, Social Limitation, Quality of Life, and Self-Efficacy), and yields 3 summary scores (Clinical Summary, Total Symptom, and Overall Summary Scores). Scale and summary scores range between 0 and 100, with higher scores indicating better health status (eg, better functioning, fewer symptoms, better quality of life). Least squares means were calculated from a mixed effects model estimating treatment effect adjusted for region, type of device, and Baseline KCCQ score.
Time frame: Baseline and Month 6
Change From Baseline to Month 6 in KCCQ Symptom Frequency Score
The KCCQ is a disease-specific patient-reported outcomes measure for patients with heart failure. It consists of 23 items, is comprised of 7 clinically relevant scales (Symptom Frequency, Symptom Burden, Symptom Stability, Physical Limitation, Social Limitation, Quality of Life, and Self-Efficacy), and yields 3 summary scores (Clinical Summary, Total Symptom, and Overall Summary Scores). Scale and summary scores range between 0 and 100, with higher scores indicating better health status (eg, better functioning, fewer symptoms, better quality of life). Least squares means were calculated from a mixed effects model estimating treatment effect adjusted for region, type of device, and Baseline KCCQ score.
Time frame: Baseline and Month 6
First patient enrolled 13 June 2006; Last patient enrolled 4 May 2012
| Milestone | Placebo | Darbepoetin Alfa |
|---|---|---|
| Started | 1142 | 1136 |
| Received investigational product | 1140 | 1133 |
| Completed | 463 | 484 |
| Not completed | 679 | 652 |
| Withdrew: Ineligibility determined | 4 | 3 |
| Withdrew: Adverse event | 83 | 65 |
| Withdrew: Withdrawal by subject | 111 | 102 |
| Withdrew: Participant request | 65 | 64 |
| Withdrew: Physician decision | 47 | 39 |
| Withdrew: Lost to follow-up | 16 | 22 |
| Withdrew: Death | 265 | 281 |
| Withdrew: Protocol violation | 64 | 59 |
| Withdrew: Pregnancy | 1 | 0 |
| Withdrew: Other | 21 | 14 |
| Withdrew: Did not receive investigational product | 2 | 3 |
Time to death from any cause or first hospital admission for worsening heart failure (adjudicated by the Clinical Endpoint Committee), whichever occurred first, estimated by Kaplan-Meier method. Participants not experiencing a qualifying event during the study were censored at their last contact time or the study termination date, whichever occurred first.
| days | Placebo | Darbepoetin Alfa |
|---|---|---|
| Time to All Cause Death or First Hospitalization for Worsening Heart Failure | 1260.0 (387.0 to 2176.0) | 1184.0 (445.0 to 2074.0) |
Time from randomization to death due to any cause, estimated by the Kaplan-Meier method. Participants not experiencing a qualifying event during the study were censored at their last contact time or the study termination date, whichever occurred first.
| days | Placebo | Darbepoetin Alfa |
|---|---|---|
| Time to Death From Any Cause | 1637.0 (766.0 to 2229.0) | 1629.0 (682.0 to 2117.0) |
Time to cardiovascular death or first hospital admission for worsening heart failure, whichever occured first, estimated using the Kaplan Meier method. Participants not experiencing a qualifying event during the study were censored at their last contact time or the study termination date, whichever occurred first.
| days | Placebo | Darbepoetin Alfa |
|---|---|---|
| Time to Cardiovascular Death or First Hospital Admission for Worsening Heart Failure | 1414.0 (429.0 to NA) | 1395.0 (483.0 to NA) |
The KCCQ is a disease-specific patient-reported outcomes measure for patients with heart failure. It consists of 23 items, is comprised of 7 clinically relevant scales (Symptom Frequency, Symptom Burden, Symptom Stability, Physical Limitation, Social Limitation, Quality of Life, and Self-Efficacy), and yields 3 summary scores (Clinical Summary, Total Symptom, and Overall Summary Scores). Scale and summary scores range between 0 and 100, with higher scores indicating better health status (eg, better functioning, fewer symptoms, better quality of life). Least squares means were calculated from a mixed effects model estimating treatment effect adjusted for region, type of device, and Baseline KCCQ score.
| units on a scale | Placebo | Darbepoetin Alfa |
|---|---|---|
| Change From Baseline to Month 6 in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score | 4.48 ± 0.68 | 6.68 ± 0.68 |
The KCCQ is a disease-specific patient-reported outcomes measure for patients with heart failure. It consists of 23 items, is comprised of 7 clinically relevant scales (Symptom Frequency, Symptom Burden, Symptom Stability, Physical Limitation, Social Limitation, Quality of Life, and Self-Efficacy), and yields 3 summary scores (Clinical Summary, Total Symptom, and Overall Summary Scores). Scale and summary scores range between 0 and 100, with higher scores indicating better health status (eg, better functioning, fewer symptoms, better quality of life). Least squares means were calculated from a mixed effects model estimating treatment effect adjusted for region, type of device, and Baseline KCCQ score.
| units on a scale | Placebo | Darbepoetin Alfa |
|---|---|---|
| Change From Baseline to Month 6 in KCCQ Symptom Frequency Score | 3.91 ± 0.76 | 6.20 ± 0.76 |
Collected over Informed consent to 30 days post treatment. Max time 72 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | — | 741/1,140 (65%) | 741/1,140 (65%) |
| Darbepoetin Alfa | — | 781/1,133 (68.9%) | 710/1,133 (62.7%) |
| Event | Placebo | Darbepoetin Alfa |
|---|---|---|
| Cardiac failureCardiac disorders | 273/1140 | 264/1133 |
| Cardiac failure congestiveCardiac disorders | 145/1140 | 126/1133 |
| PneumoniaInfections and infestations | 71/1140 | 86/1133 |
| Renal failure acuteRenal and urinary disorders | 62/1140 | 58/1133 |
| AnaemiaBlood and lymphatic system disorders | 49/1140 | 23/1133 |
| Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | 42/1140 | 22/1133 |
| Renal failureRenal and urinary disorders | 37/1140 | 41/1133 |
| Myocardial infarctionCardiac disorders | 35/1140 | 36/1133 |
| Cardiac deathGeneral disorders | 29/1140 | 34/1133 |
| Atrial fibrillationCardiac disorders | 30/1140 | 32/1133 |
| Event | Placebo | Darbepoetin Alfa |
|---|---|---|
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 174/1140 | 157/1133 |
| DiarrhoeaGastrointestinal disorders | 135/1140 | 148/1133 |
| DizzinessNervous system disorders | 143/1140 | 138/1133 |
| CoughRespiratory, thoracic and mediastinal disorders | 132/1140 | 126/1133 |
| Oedema peripheralGeneral disorders | 118/1140 | 115/1133 |
| NasopharyngitisInfections and infestations | 111/1140 | 117/1133 |
| AstheniaGeneral disorders | 112/1140 | 88/1133 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 78/1140 | 101/1133 |
| BronchitisInfections and infestations | 88/1140 | 99/1133 |
| Upper respiratory tract infectionInfections and infestations | 73/1140 | 95/1133 |
| Age, Continuous(years) | Placebo | Darbepoetin Alfa | Total |
|---|---|---|---|
| Mean | 69.6 ± 11.3 | 70.0 ± 11.6 | 69.8 ± 11.4 |
| Sex: Female, Male(Participants) | Placebo | Darbepoetin Alfa | Total |
|---|---|---|---|
| Female | 486 | 458 | 944 |
| Male | 656 | 678 | 1334 |
| Race/Ethnicity, Customized(participants) | Placebo | Darbepoetin Alfa | Total |
|---|---|---|---|
| White or Caucasian | 768 | 781 | 1549 |
| Black or African American | 113 | 89 | 202 |
| Hispanic or Latino | 84 | 98 | 182 |
| Asian | 162 | 162 | 324 |
| Japanese | 0 | 1 | 1 |
| American Indian or Alaska Native | 2 | 2 | 4 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 1 |
| Other | 12 | 3 | 15 |
| Region(participants) | Placebo | Darbepoetin Alfa | Total |
|---|---|---|---|
| North America | 323 | 321 | 644 |
| Latin America and Asia | 286 | 285 | 571 |
| Western Europe, Israel, South Africa, Australia | 306 | 303 | 609 |
| Eastern Europe and Russia | 227 | 227 | 454 |
| Device Usage(participants) | Placebo | Darbepoetin Alfa | Total |
|---|---|---|---|
| CRT with or without ICD | 143 | 143 | 286 |
| ICD without CRT | 124 | 122 | 246 |
| None | 875 | 871 | 1746 |
| Kansas City Cardiomyopathy Questionnaire: Overall Summary Score(units on a scale) | Placebo | Darbepoetin Alfa | Total |
|---|---|---|---|
| Mean | 56.5 ± 22.5 | 55.8 ± 22.6 | 56.2 ± 22.5 |
| Study Specific Characteristic [Kansas City Cardiomyopathy Questionnaire: Symptom Frequency Scale(units on a scale) | Placebo | Darbepoetin Alfa | Total |
|---|---|---|---|
| Mean | 63.3 ± 25.2 | 63.1 ± 25.6 | 63.2 ± 25.4 |
Showing the first 100 of 754 sites across 36 countries.
This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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