18 and older, any sex, with Heart Failure or Anemia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Time to All Cause Death or First Hospitalization for Worsening Heart FailurePrimary· From randomization to the end of study; maximum time on study was 73 months
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.
Group
Value
95% CI
Placebo
1260.0
387.0 – 2176.0
Darbepoetin Alfa
1184.0
445.0 – 2074.0
Time to Death From Any CauseSecondary· From randomization to the end of study; maximum time on study was 73 months
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.
Group
Value
95% CI
Placebo
1637.0
766.0 – 2229.0
Darbepoetin Alfa
1629.0
682.0 – 2117.0
Time to Cardiovascular Death or First Hospital Admission for Worsening Heart FailureSecondary· 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, 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.
Group
Value
95% CI
Placebo
1414.0
429.0 – NA
Darbepoetin Alfa
1395.0
483.0 – NA
Change From Baseline to Month 6 in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary ScoreSecondary· Baseline and Month 6
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
Group
Value
95% CI
Placebo
4.48
± 0.68
Darbepoetin Alfa
6.68
± 0.68
Change From Baseline to Month 6 in KCCQ Symptom Frequency ScoreSecondary· Baseline and Month 6
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
Group
Value
95% CI
Placebo
3.91
± 0.76
Darbepoetin Alfa
6.20
± 0.76
Adverse events — posted to ClinicalTrials.gov
Time frame: Informed consent to 30 days post treatment. Max time 72 months.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Amgen
Last refreshed: 8 November 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00358215.