RED-HF™ Trial - Reduction of Events With Darbepoetin Alfa in Heart Failure Trial

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00358215
First received: July 27, 2006
Last updated: July 14, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Heart Failure
Anemia
Cardiovascular Disease
Ventricular Dysfunction
Congestive Heart Failure
Drug: Darbepoetin alfa
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Time to All Cause Death or First Hospitalization for Worsening Heart Failure [ Time Frame: From randomization to the end of study; maximum time on study was 73 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Time to Death From Any Cause [ Time Frame: From randomization to the end of study; maximum time on study was 73 months ] [ Designated as safety issue: Yes ]
    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 to Cardiovascular Death or First Hospital Admission for Worsening Heart Failure [ Time Frame: From randomization to the end of study; maximum time on study was 73 months ] [ Designated as safety issue: Yes ]
    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.

  • Change From Baseline to Month 6 in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline to Month 6 in KCCQ Symptom Frequency Score [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ]
    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.


Enrollment: 2278
Study Start Date: June 2006
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Darbepoetin alfa
Administered by subcutaneous injection
Other Name: Aranesp®
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.
Drug: Placebo
Placebo subcutaneous injection

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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%

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)
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00358215

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Campbell River, British Columbia, Canada, V9W 5Y4
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Surrey, British Columbia, Canada, V3V 1Z2
Canada, Manitoba
Research Site
Winnipeg, Manitoba, Canada, R3T 2E8
Research Site
Winnipeg, Manitoba, Canada, R3C 0N2
Canada, Newfoundland and Labrador
Research Site
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Nova Scotia
Research Site
Halifax, Nova Scotia, Canada, B3H 3A7
Canada, Ontario
Research Site
Ajax, Ontario, Canada, L1S 7K8
Research Site
Cambridge, Ontario, Canada, N1R 7R1
Research Site
Hamilton, Ontario, Canada, L8L 2X2
Research Site
Kingston, Ontario, Canada, K7L 1C2
Research Site
London, Ontario, Canada, N6A 5A5
Research Site
Mississauga, Ontario, Canada, L5B 4A2
Research Site
North York, Ontario, Canada, M2K 2W2
Research Site
Ottawa, Ontario, Canada, K1Y 4W7
Research Site
Scarborough, Ontario, Canada, M1P 2V5
Research Site
Scarborough, Ontario, Canada, M1E 5E9
Research Site
Toronto, Ontario, Canada, M5G 2C4
Research Site
Toronto, Ontario, Canada, M5B 1W8
Research Site
Toronto, Ontario, Canada, M5G 1X5
Canada, Quebec
Research Site
Montreal, Quebec, Canada, H3G 1A4
Research Site
Montreal, Quebec, Canada, H1T 2M4
Research Site
Montreal, Quebec, Canada, H2W 1T8
Research Site
Montreal, Quebec, Canada, H2W 1T7
Research Site
Montreal, Quebec, Canada, H3A 1A1
Research Site
Sherbrooke, Quebec, Canada, J1H 5N4
Research Site
St-Jérôme, Quebec, Canada, J7Z 5T3
Canada, Saskatchewan
Research Site
Regina, Saskatchewan, Canada, S4P 3X3
Research Site
Saskatoon, Saskatchewan, Canada, S7H 5H9
Chile
Research Site
Rancagua, Cachapoal, Chile, 2841959
Research Site
La Serena, Elqui, Chile, 1731295
Research Site
San Miguel, Santiago, Chile, 8900085
Research Site
Osorno, Chile
Research Site
Santiago, Chile, 8320000
Research Site
Santiago, Chile, 8330032
Research Site
Santiago, Chile, 7500922
Research Site
Santiago, Chile
Research Site
Temuco, Chile, 4781151
Research Site
Vina del Mar, Chile
Czech Republic
Research Site
Benesov, Czech Republic, 256 01
Research Site
Brno, Czech Republic, 656 91
Research Site
Ceske Budejovice, Czech Republic, 370 87
Research Site
Jihlava, Czech Republic, 586 01
Research Site
Karlovy Vary, Czech Republic, 360 01
Research Site
Pardubice, Czech Republic, 530 02
Research Site
Praha 1, Czech Republic, 110 00
Research Site
Praha 10, Czech Republic, 100 34
Research Site
Praha 10, Czech Republic, 108 00
Research Site
Praha 2, Czech Republic, 120 00
Research Site
Praha 2, Czech Republic, 128 08
Research Site
Pribram 8, Czech Republic, 261 01
Research Site
Tabor, Czech Republic, 390 03
Research Site
Usti nad Labem, Czech Republic, 401 13
Denmark
Research Site
Fredericia, Denmark, 7000
Research Site
Frederiksberg, Denmark, 2000
Research Site
Frederikshavn, Denmark, 9900
Research Site
Glostrup, Denmark, 2600
Research Site
Hellerup, Denmark, 2900
Research Site
Herlev, Denmark, 2730
Research Site
Horsens, Denmark, 8700
Research Site
Hvidovre, Denmark, 2650
Research Site
København S, Denmark, 2300
Research Site
København Ø, Denmark, 2011
Research Site
Køge, Denmark, 4600
Research Site
Odense, Denmark, 5000
Research Site
Roskilde, Denmark, 4000
Research Site
Svendborg, Denmark, 5700
Estonia
Research Site
Pärnu, Estonia, 80010
Research Site
Tallinn, Estonia, 13419
Research Site
Tallinn, Estonia, 10617
Research Site
Tallinn, Estonia, 10138
Finland
Research Site
Espoo, Finland, 00029
Research Site
Helsinki, Finland, 00260
Research Site
Lahti, Finland, 15110
Research Site
Seinajoki, Finland, 60100
France
Research Site
Bron, France, 69500
Research Site
Caen Cedex 14, France, 14033
Research Site
Cholet Cedex, France, 49325
Research Site
Créteil Cedex, France, 94010
Research Site
Douai Cedex, France, 59507
Research Site
Grenoble Cedex 9, France, 38043
Research Site
Lille Cedex, France, 59037
Research Site
Montfermeil, France, 93370
Research Site
Montpellier cedex 05, France, 34295
Research Site
Nice Cedex 01, France, 06002
Research Site
Paris, France, 75010
Research Site
Paris Cedex 13, France, 75651
Research Site
Pessac Cedex, France, 33604
Research Site
Poitiers, France, 86000
Research Site
Pontoise Cedex, France, 95301
Research Site
Rouen Cedex, France, 76031
Research Site
Saint Herblain, France, 44800
Research Site
Strasbourg, France, 67091
Research Site
Toulouse Cedex 09, France, 31403
Research Site
Vandoeuvre-les-Nancy, France, 54511
Germany
Research Site
Bad Tölz, Germany, 83646
Research Site
Berlin, Germany, 13353
Research Site
Berlin, Germany, 10787
Research Site
Berlin, Germany, 12200
Research Site
Bochum, Germany, 44789
Research Site
Bremen, Germany, 28277
Research Site
Frankfurt, Germany, 60594
Research Site
Georgsmarienhütte, Germany, 49124
Research Site
Göttingen, Germany, 37075
Research Site
Hamburg, Germany, 20246
Research Site
Hamburg, Germany, 20148
Research Site
Hannover, Germany, 30625
Research Site
Heidelberg, Germany, 69120
Research Site
Heidelberg, Germany, 69115
Research Site
Homburg, Germany, 66421
Research Site
Ingelheim, Germany, 55218
Research Site
Köln, Germany, 50924
Research Site
Lahr, Germany, 77933
Research Site
Leipzig, Germany, 04289
Research Site
Mainz, Germany, 55131
Research Site
Marburg, Germany, 35037
Research Site
Nürnberg, Germany, 90402
Research Site
Schwedt, Germany, 16303
Research Site
Stuttgart, Germany, 70376
Research Site
Witten, Germany, 58455
Hong Kong
Research Site
Hong Kong, Hong Kong
Research Site
New Territories, Hong Kong, 00000
Hungary
Research Site
Bekescsaba, Hungary, 5600
Research Site
Budapest, Hungary, 1027
Research Site
Budapest, Hungary, 1096
Research Site
Budapest, Hungary, 1135
Research Site
Budapest, Hungary, 1075
Research Site
Budapest, Hungary, 1106
Research Site
Budapest, Hungary, 1115
Research Site
Debrecen, Hungary, 4032
Research Site
Gyor, Hungary, 9023
Research Site
Kalocsa, Hungary, 6300
Research Site
Kecskemet, Hungary, 6000
Research Site
Sopron, Hungary, 9400
Research Site
Szeged, Hungary, 6720
Research Site
Szekesfehervar, Hungary, 8000
Research Site
Szekszard, Hungary, 7100
Research Site
Szolnok, Hungary, 5000
Research Site
Veszprem, Hungary, 8200
Research Site
Zalaegerszeg, Hungary, 8900
India
Research Site
Hyderabad, Andhra Pradesh, India, 500 033
Research Site
Hyderabad, Andhra Pradesh, India, 500 001
Research Site
Hyderabad, Andhra Pradesh, India, 500 063
Research Site
New Delhi, Delhi, India, 110 029
Research Site
New Delhi, Delhi, India, 110 025
Research Site
Ahmedabad, Gujarat, India, 380 006
Research Site
Ahmedabad, Gujarat, India, 380 060
Research Site
Ahmedabad, Gujarat, India, 382 428
Research Site
Gurgaon, Haryana, India, 122 001
Research Site
Bangalore, Karnataka, India, 560 034
Research Site
Bangalore, Karnataka, India, 560 054
Research Site
Mumbai, Maharashtra, India, 400 022
Research Site
Nagpur, Maharashtra, India, 400 012
Research Site
Nashik, Maharashtra, India, 422 005
Research Site
Pune, Maharashtra, India, 411 006
Research Site
Pune, Maharashtra, India, 411 001
Research Site
Pune, Maharashtra, India, 411 033
Research Site
Pune, Maharashtra, India, 411 004
Research Site
Pune, Maharashtra, India, 411 011
Research Site
Pune, Maharashtra, India, 411 016
Research Site
Ludhiana, Punjab, India, 141 001
Research Site
Bikaner, Rajasthan, India, 334 003
Research Site
Chennai, Tamil Nadu, India, 600 081
Research Site
Chennai, Tamil Nadu, India, 600 006
Research Site
Chennai, Tamil Nadu, India, 600 037
Research Site
Coimbatore, Tamil Nadu, India, 641 004
Research Site
Coimbatore, Tamil Nadu, India, 641 014
Research Site
Madurai, Tamil Nadu, India, 625 020
Research Site
Lucknow, Uttar Pradesh, India, 226 014
Research Site
Mumbai, India, 400 020
Israel
Research Site
Askelon, Israel, 78278
Research Site
Beer Sheva, Israel, 84101
Research Site
Beer Yaakov, Israel, 70300
Research Site
Givatayim, Israel, 53583
Research Site
Hadera, Israel, 38100
Research Site
Haifa, Israel, 34362
Research Site
Holon, Israel, 58100
Research Site
Jerusalem, Israel, 91200
Research Site
Jerusalem, Israel, 91031
Research Site
Kfar Saba, Israel, 44281
Research Site
Safed, Israel, 13100
Research Site
Tel-Aviv, Israel, 64239
Italy
Research Site
Arezzo, Italy, 52100
Research Site
Bergamo, Italy, 24128
Research Site
Cesenatico (FC), Italy, 47042
Research Site
Cetraro CS, Italy, 87022
Research Site
Cortona AR, Italy, 52044
Research Site
Eboli, Italy, 84025
Research Site
Ferrara, Italy, 44100
Research Site
Forlì, Italy, 47100
Research Site
Milano, Italy, 20138
Research Site
Napoli, Italy, 80131
Research Site
Oliveto Citra SA, Italy, 84020
Research Site
Palermo, Italy, 90126
Research Site
Palmanova UD, Italy, 33057
Research Site
Pavia, Italy, 27100
Research Site
Roma, Italy, 00184
Research Site
Roma, Italy, 00152
Research Site
Rozzano MI, Italy, 20089
Research Site
San Bonifacio VR, Italy, 37047
Research Site
Torino, Italy, 10126
Research Site
Trento, Italy, 38100
Research Site
Udine, Italy, 33100
Latvia
Research Site
Daugavpils, Latvia, 5417
Research Site
Ogre, Latvia, 5001
Research Site
Rezekne, Latvia, 4600
Research Site
Riga, Latvia, 1038
Research Site
Riga, Latvia, 1012
Research Site
Riga, Latvia, 1002
Research Site
Riga, Latvia, 1006
Lithuania
Research Site
Alytus, Lithuania, 62114
Research Site
Kaunas, Lithuania, 44320
Research Site
Kaunas, Lithuania, 50009
Research Site
Kaunas, Lithuania, 49155
Research Site
Klaipeda, Lithuania, 92288
Research Site
Siauliai, Lithuania, 76231
Research Site
Vilnius, Lithuania, 01113
Research Site
Vilnius, Lithuania, 10309
Research Site
Vilnius, Lithuania, 08661
Research Site
Vilnius, Lithuania, 08314
Mexico
Research Site
Mexico City, Distrito Federal, Mexico, 14080
Research Site
Guadajalara, Jalisco, Mexico, 44100
Research Site
Guadalajara, Jalisco, Mexico, 44340
Research Site
Guadalajara, Jalisco, Mexico, 44380
Research Site
Monterrey, Nuevo León, Mexico, 64000
Research Site
San Luis Potosi, San Luis PotosÃ-, Mexico, 78240
Research Site
Xalapa, Veracruz, Mexico, 91140
Research Site
Merida, Yucatán, Mexico, 97000
Research Site
Baja California, Mexico, 21397
Research Site
Distrito Federal, Mexico, 06760
Netherlands
Research Site
's Hertogenbosch, Netherlands, 5211 RW
Research Site
Alkmaar, Netherlands, 1815 JD
Research Site
Almelo, Netherlands, 7609 PP
Research Site
Amsterdam, Netherlands, 1091 AC
Research Site
Arnhem, Netherlands, 6815 AD
Research Site
Assen, Netherlands, 9401 RK
Research Site
Blaricum, Netherlands, 1261 AN
Research Site
Breda, Netherlands, 4818 CK
Research Site
Delft, Netherlands, 2625 AD
Research Site
Den Haag, Netherlands, 2512 VA
Research Site
Deventer, Netherlands, 7416 SE
Research Site
Eindhoven, Netherlands, 5623 EJ
Research Site
Enschede, Netherlands, 7513 ER
Research Site
Groningen, Netherlands, 9713 GZ
Research Site
Haarlem, Netherlands, 2035 RC
Research Site
Harderwijk, Netherlands, 3844 DG
Research Site
Heerlen, Netherlands, 6419 PC
Research Site
Hilversum, Netherlands, 1213 XZ
Research Site
Hoorn, Netherlands, 1625 HV
Research Site
Nijmegen, Netherlands, 6532 SZ
Research Site
Rotterdam, Netherlands, 3083 AN
Research Site
Rotterdam, Netherlands, 3045 PM
Research Site
Sneek, Netherlands, 8601 ZK
Research Site
Tiel, Netherlands, 4002 WP
Research Site
Tilburg, Netherlands, 5042 AD
Research Site
Zwijndrecht, Netherlands, 3331 LZ
Norway
Research Site
Arendal, Norway, 4809
Research Site
Gjettum, Norway, 1309
Research Site
Kristiansand, Norway, 4604
Research Site
Oslo, Norway, 0407
Research Site
Skien, Norway, 3710
Research Site
Stavanger, Norway, 4095
Research Site
Ã…lesund, Norway, 6026
Poland
Research Site
Bialystok, Poland, 15-276
Research Site
Gdansk, Poland, 80-952
Research Site
Gdynia, Poland, 81-423
Research Site
Gdynia, Poland, 81-519
Research Site
Katowice, Poland, 40-635
Research Site
Krakow, Poland, 31-202
Research Site
Krakow, Poland, 30-092
Research Site
Lublin, Poland, 20-954
Research Site
Stalowa Wola, Poland, 37-450
Research Site
Tarnow, Poland, 33-100
Research Site
Walbrzych, Poland, 58-309
Research Site
Warszawa, Poland, 01-211
Research Site
Warszawa, Poland, 04-628
Research Site
Warszawa, Poland, 04-238
Research Site
Warszawa, Poland, 01-809
Research Site
Warszawa, Poland, 03-242
Research Site
Wroclaw, Poland, 50-981
Research Site
Zabrze, Poland, 41-800
Research Site
Zielona Gora, Poland, 65-046
Portugal
Research Site
Coimbra, Portugal, 3000-075
Research Site
Faro, Portugal, 8000-386
Research Site
Lisboa, Portugal, 1449-005
Research Site
Lisbon, Portugal, 1169-024
Puerto Rico
Research Site
San Juan, Puerto Rico, 00935
Romania
Research Site
Arad, Romania, 310031
Research Site
Bacau, Romania, 600114
Research Site
Brasov, Romania, 500157
Research Site
Bucuresti, Romania, 022328
Research Site
Bucuresti, Romania, 011461
Research Site
Bucuresti, Romania, 021659
Research Site
Bucuresti, Romania, 030171
Research Site
Iasi, Romania, 700111
Research Site
Oradea, Romania, 410169
Research Site
Sibiu, Romania, 550245
Research Site
Targu Mures, Romania, 540103
Research Site
Targu Mures, Romania, 540136
Research Site
Timisoara, Romania, 300041
Research Site
Timisoara, Romania, 300310
Russian Federation
Research Site
Moscow, Russian Federation, 129090
Research Site
Moscow, Russian Federation, 119992
Research Site
Moscow, Russian Federation, 115516
Research Site
Moscow, Russian Federation, 109263
Research Site
Moscow, Russian Federation, 127473
Research Site
Moscow, Russian Federation, 117292
Research Site
Moscow, Russian Federation, 127018
Research Site
Moscow, Russian Federation, 121359
Research Site
Moscow, Russian Federation, 125315
Research Site
Moscow, Russian Federation, 119435
Research Site
Moscow, Russian Federation, 117513
Research Site
Moscow, Russian Federation, 121552
Research Site
Moscow, Russian Federation, 107014
Research Site
Moscow, Russian Federation, 127644
Research Site
Moscow, Russian Federation, 125206
Research Site
Moscow, Russian Federation, 115093
Research Site
Moscow, Russian Federation, 119620
Research Site
Saint Petersburg, Russian Federation, 192242
Research Site
Saint Petersburg, Russian Federation, 197022
Research Site
Sankt-Petersburg, Russian Federation, 194156
Research Site
St Petersburg, Russian Federation, 198205
Research Site
St. Petersburg, Russian Federation, 199106
Research Site
St. Petersburg, Russian Federation, 194017
Research Site
Volgograd, Russian Federation, 400008
Slovakia
Research Site
Bardejov, Slovakia, 085 01
Research Site
Bratislava, Slovakia, 811 00
Research Site
Kosice, Slovakia, 040 22
Research Site
Levice, Slovakia, 934 48
Research Site
Lucenec, Slovakia, 984 01
Research Site
Nitra, Slovakia, 949 01
Research Site
Nitra, Slovakia, 950 01
Research Site
Presov, Slovakia, 080 01
Research Site
Zilina, Slovakia, 012 07
South Africa
Research Site
Boksburg, Gauteng, South Africa, 1459
Research Site
Johannesburg, Gauteng, South Africa, 2157
Research Site
Johannesburg, Gauteng, South Africa, 2193
Research Site
Pretoria, Gauteng, South Africa, 0002
Research Site
Soweto, Gauteng, South Africa, 2013
Research Site
Durban, KwaZulu-Natal, South Africa, 4001
Research Site
Durban, KwaZulu-Natal, South Africa, 4068
Research Site
Durban, KwaZulu-Natal, South Africa, 4052
Research Site
Parow, Western Cape, South Africa, 7505
Research Site
Somerset West, Western Cape, South Africa, 7130
Research Site
Worcester, Western Cape, South Africa, 6850
Research Site
Cape Town, South Africa, 7405
Research Site
Cape Town, South Africa, 7530
Spain
Research Site
Córdoba, AndalucÃ-a, Spain, 14004
Research Site
Granada, AndalucÃ-a, Spain, 18014
Research Site
Málaga, AndalucÃ-a, Spain, 29010
Research Site
Oviedo, Asturias, Spain, 33006
Research Site
Santander, Cantabria, Spain, 39008
Research Site
Badalona, Cataluña, Spain, 08916
Research Site
Barcelona, Cataluña, Spain, 08041
Research Site
Barcelona, Cataluña, Spain, 08035
Research Site
Barcelona, Cataluña, Spain, 08003
Research Site
Barcelona, Cataluña, Spain, 08036
Research Site
Sabadell, Cataluña, Spain, 08208
Research Site
Tarragona, Cataluña, Spain, 43007
Research Site
Valencia, Comunidad Valenciana, Spain, 46014
Research Site
Santiago de Compostela, Galicia, Spain, 15706
Research Site
Majadhonda, Madrid, Spain, 28222
Research Site
El Palmar, Murcia, Spain, 30120
Research Site
Galdakao, PaÃ-s Vasco, Spain, 48960
Research Site
Madrid, Spain, 28034
Research Site
Madrid, Spain, 28041
Research Site
Madrid, Spain, 28046
Sweden
Research Site
Danderyd, Sweden, 182 88
Research Site
Göteborg, Sweden, 413 45
Research Site
Göteborg, Sweden, 416 85
Research Site
Linköping, Sweden, 581 85
Research Site
Malmö, Sweden, 205 02
Research Site
Mölndal, Sweden, 431 80
Research Site
Stockholm, Sweden, 112 81
Research Site
Sundsvall, Sweden, 851 56
Research Site
Umeå, Sweden, 901 85
Research Site
Uppsala, Sweden, 751 85
Research Site
Ã-rebro, Sweden, 701 85
Switzerland
Research Site
Lugano, Switzerland, 6900
Research Site
St. Gallen, Switzerland, 9007
United Kingdom
Research Site
Barnet, United Kingdom, EN5 3DJ
Research Site
Belfast, United Kingdom, BT12 6BA
Research Site
Birmingham, United Kingdom, B757RR
Research Site
Bradford, United Kingdom, BD9 6RJ
Research Site
Bridlington, United Kingdom, YO164QP
Research Site
Cottingham, United Kingdom, HU16 5JQ
Research Site
Coventry, United Kingdom, CV2 2DX
Research Site
Glasgow, United Kingdom, G51 4TF
Research Site
Glasgow, United Kingdom, G12 8TA
Research Site
Harrow, United Kingdom, HA1 3UJ
Research Site
Kirkcaldy, United Kingdom, KY2 5AH
Research Site
Leeds, United Kingdom, LS1 3EX
Research Site
Leeds, United Kingdom, LS9 7TF
Research Site
Leicester, United Kingdom, LE3 9QP
Research Site
Livingston, United Kingdom, EH54 6PP
Research Site
London, United Kingdom, SE1 7EH
Research Site
Manchester, United Kingdom, M8 5RB
Research Site
Romford, United Kingdom, RM7 0AG
Research Site
Stockport, United Kingdom, SK2 7JE
Research Site
Worcester, United Kingdom, WR5 1DD
Research Site
Worthing, United Kingdom, BN11 2DH
Research Site
York, United Kingdom, YO31 8HE
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided by Amgen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00358215     History of Changes
Other Study ID Numbers: 20050222, RED-HF™ Trial
Study First Received: July 27, 2006
Results First Received: October 23, 2013
Last Updated: July 14, 2014
Health Authority: Argentina: ANMAT (Administracion Nacional de Medicamentos Alimentos y Tecnologia Medica)
Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria: AGES - PharmaMed Austria Institut Wissenschaft & Information
Belgium: Federal Public Service
Brazil: ANVISA (Agência Nacional de Vigilância Sanitária)
Bulgaria: Bulgarian Drug Agency
Bulgaria: Ministry of Health
Canada: Health Canada
Chile: Health Ministry
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
Estonia: State Agency of Medicines
Finland: Lääkelaitos
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Hungary: National Institute of Pharmacy
India: Central Drugs Standard Control Organization
Ireland: Irish Medicines Board (IMB)
Israel: Ministry of Health
Italy: Local Ethics Committees
Latvia: State Agency of Medicines
Lithuania: State Medicines Control Agency of Lithuania
Mexico: Ministry of Health
Netherlands: CCMO (Centrale Commissie Mensgebonden Onderzoek): Central Committee Human Bound Research
Norway: Norwegian Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Portugal: Instituto Nacional da Farmácia e do Medicamento (INFARMED)
Romania: Romanian National Drug Agency
Russia: Ministry of Health
Slovakia: Štátny ústav pre kontrolu lieciv
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Sweden: Medical Products Agency
Switzerland: Swissmedic (Swiss Agency for Therapeutic Products)
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration
Ukraine: Ministry of Health

Keywords provided by Amgen:
Survival study
morbidity and mortality
heart failure hospitalization
all-cause death
patient-reported outcomes
Kansas City Cardiomyopathy questionnaire
anemia treatment

Additional relevant MeSH terms:
Anemia
Cardiovascular Diseases
Heart Failure
Ventricular Dysfunction
Heart Diseases
Hematologic Diseases
Darbepoetin alfa
Hematinics
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014