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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00358215




Registration number
NCT00358215
Ethics application status
Date submitted
27/07/2006
Date registered
31/07/2006
Date last updated
8/11/2022

Titles & IDs
Public title
RED-HFâ„¢ Trial - Reduction of Events With Darbepoetin Alfa in Heart Failure Trial
Scientific title
A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Darbepoetin Alfa Treatment on Mortality and Morbidity in Heart Failure (HF) Subjects With Symptomatic Left Ventricular Systolic Dysfunction and Anemia
Secondary ID [1] 0 0
RED-HFâ„¢ Trial
Secondary ID [2] 0 0
20050222
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 0 0
Anemia 0 0
Cardiovascular Disease 0 0
Ventricular Dysfunction 0 0
Congestive Heart Failure 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Blood 0 0 0 0
Anaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Darbepoetin alfa
Treatment: Drugs - Placebo

Experimental: Darbepoetin alfa - 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.

Placebo comparator: Placebo - Participants received dose and administration schedule (every 2 weeks or once a month) changes that simulated the changes for participants receiving darbepoetin alfa.


Treatment: Drugs: Darbepoetin alfa
Administered by subcutaneous injection

Treatment: Drugs: Placebo
Placebo subcutaneous injection

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to All Cause Death or First Hospitalization for Worsening Heart Failure
Timepoint [1] 0 0
From randomization to the end of study; maximum time on study was 73 months
Secondary outcome [1] 0 0
Time to Death From Any Cause
Timepoint [1] 0 0
From randomization to the end of study; maximum time on study was 73 months
Secondary outcome [2] 0 0
Time to Cardiovascular Death or First Hospital Admission for Worsening Heart Failure
Timepoint [2] 0 0
From randomization to the end of study; maximum time on study was 73 months
Secondary outcome [3] 0 0
Change From Baseline to Month 6 in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score
Timepoint [3] 0 0
Baseline and Month 6
Secondary outcome [4] 0 0
Change From Baseline to Month 6 in KCCQ Symptom Frequency Score
Timepoint [4] 0 0
Baseline and Month 6

Eligibility
Key inclusion criteria
* Heart failure of at least 3 months duration and of New York Heart Association (NYHA) class II, III, or IV
* hemoglobin between 9.0 g/dL and 12.0 g/dL
* left ventricular ejection fraction equal to or less than 40%
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Transferrin saturation (Tsat) < 15%
* Blood pressure > 160/100 mm Hg
* Heart failure primarily due to valvular heart disease or clinically significant valvular heart disease that might lead to surgical correction within 12 months of randomization
* Recipient of a major organ transplant or receiving renal replacement therapy
* Serum creatinine > 3.0 mg/dL (> 265 µmol/L)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Netherlands
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Netherlands
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Kristiansand
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Norway
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Poland
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York

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Amgen
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.