RED-HF™ Trial - Reduction of Events With Darbepoetin Alfa in Heart Failure Trial
This study has been completed.
Sponsor:
Amgen
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00358215
First received: July 27, 2006
Last updated: January 24, 2013
Last verified: January 2013
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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 HF in subjects 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:
- To determine the efficacy of darbepoetin alfa compared to placebo on the composite of time to death from any cause or first hospital admission for worsening HF in subjects with symptomatic left ventricular systolic dysfunction and anemia. [ Time Frame: Duration of study ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To evaluate the effects of treatment with darbepoetin alfa on time to death from any cause [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]
- To evaluate the effects of treatment with darbepoetin alfa on time to cardiovascular death or first hospital admission for worsening HF, whichever occurs first [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]
- To evaluate the effects of treatment with darbepoetin alfa on change from baseline to month 6 in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score [ Time Frame: Six months ] [ Designated as safety issue: No ]
- To evaluate the effects of treatment with darbepoetin alfa on change from baseline to month 6 in KCCQ Symptom Frequency Score [ Time Frame: Six months ] [ Designated as safety issue: No ]
| Enrollment: | 2278 |
| Study Start Date: | June 2006 |
| Study Completion Date: | January 2013 |
| Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Active |
Drug: Darbepoetin alfa
Starting dose: 0.75 mcg/kg subcutaneously Q2W Subsequent doses: - Darbepoetin alfa group to receive darbepoetin alfa titrated to achieve Hb target of 13.0 g/dL, not to exceed 14.5 g/dL |
| Placebo Comparator: Placebo |
Drug: Placebo
Placebo group to receive volume and dose frequency changes resembling titration dosing in the treatment group
|
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 subjects 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:
- HF of at least 3 months duration and of 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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00358215
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| Australia, Queensland | |
| Research Site | |
| Chermside, Queensland, Australia, 4032 | |
| Research Site | |
| Kippa Ring, Queensland, Australia, 4021 | |
| Research Site | |
| Woolloongabba, Queensland, Australia, 4102 | |
| Australia, South Australia | |
| Research Site | |
| Bedford Park, South Australia, Australia, 5042 | |
| Australia, Victoria | |
| Research Site | |
| Geelong, Victoria, Australia, 3220 | |
| Research Site | |
| Heidelberg, Victoria, Australia, 3084 | |
| Research Site | |
| Parkville, Victoria, Australia, 3052 | |
| Research Site | |
| Prahran, Victoria, Australia, 3181 | |
| Australia, Western Australia | |
| Research Site | |
| Nedlands, Western Australia, Australia, 6009 | |
| Austria | |
| Research Site | |
| Innsbruck, Austria, 6020 | |
| Research Site | |
| Linz, Austria, 4010 | |
| Research Site | |
| Linz, Austria, 4021 | |
| Research Site | |
| Salzburg, Austria, 5020 | |
| Research Site | |
| Wels, Austria, 4600 | |
| Research Site | |
| Wien, Austria, 1090 | |
| Research Site | |
| Wien, Austria, 1150 | |
| Belgium | |
| Research Site | |
| Aalst, Belgium, 9300 | |
| Research Site | |
| Antwerpen, Belgium, 2020 | |
| Research Site | |
| Antwerpen, Belgium, 2060 | |
| Research Site | |
| Bonheiden, Belgium, 2820 | |
| Research Site | |
| Brugge, Belgium, 8000 | |
| Research Site | |
| Brussel, Belgium, 1090 | |
| Research Site | |
| Bruxelles, Belgium, 1070 | |
| Research Site | |
| Genk, Belgium, 3600 | |
| Research Site | |
| Gent, Belgium, 9000 | |
| Research Site | |
| Hasselt, Belgium, 3500 | |
| Research Site | |
| Huy, Belgium, 4500 | |
| Research Site | |
| Leuven, Belgium, 3000 | |
| Research Site | |
| Roeselare, Belgium, 8800 | |
| Research Site | |
| Turnhout, Belgium, 2300 | |
| Brazil | |
| Research Site | |
| Salvador, Bahia, Brazil, 40144-900 | |
| Research Site | |
| Fortaleza, Ceará, Brazil, 60864-194 | |
| Research Site | |
| Goiania, Goiás, Brazil, 74605-050 | |
| Research Site | |
| Belo Horizonte, Minas Gerais, Brazil, 30110-908 | |
| Research Site | |
| Curitiba, Paraná, Brazil, 80010-030 | |
| Research Site | |
| Recife, Pernambuco, Brazil, 50100-060 | |
| Research Site | |
| Porto Alegre, Rio Grande do Sul, Brazil, 90035-903 | |
| Research Site | |
| Porto Alegre, Rio Grande do Sul, Brazil, 90620-001 | |
| Research Site | |
| Porto Alegre, Rio Grande do Sul, Brazil, 90020-090 | |
| Research Site | |
| Campinas, São Paulo, Brazil, 13059-740 | |
| Research Site | |
| Riberão Preto, São Paulo, Brazil, 14048-900 | |
| Research Site | |
| Sao Paulo, São Paulo, Brazil, 05403-900 | |
| Research Site | |
| Sao Paulo, São Paulo, Brazil, 04012-909 | |
| Research Site | |
| São José do Rio Preto, São Paulo, Brazil, 15090-000 | |
| Research Site | |
| Rio De Janeiro, Brazil, 22271-100 | |
| Research Site | |
| Rio de Janeiro, Brazil, 20020-020 | |
| Research Site | |
| Rio de Janeiro, Brazil, 20551-030 | |
| Research Site | |
| São Paulo, Brazil, 04025-002 | |
| Bulgaria | |
| Research Site | |
| Dimitrovgrad, Bulgaria, 6400 | |
| Research Site | |
| Haskovo, Bulgaria, 6300 | |
| Research Site | |
| Pleven, Bulgaria, 5800 | |
| Research Site | |
| Plovdiv, Bulgaria, 4003 | |
| Research Site | |
| Plovdiv, Bulgaria, 4002 | |
| Research Site | |
| Plovdiv, Bulgaria, 4000 | |
| Research Site | |
| Rouse, Bulgaria, 7002 | |
| Research Site | |
| Sofia, Bulgaria, 1527 | |
| Research Site | |
| Sofia, Bulgaria, 1202 | |
| Research Site | |
| Sofia, Bulgaria, 1309 | |
| Research Site | |
| Sofia, Bulgaria, 1233 | |
| Research Site | |
| Sofia, Bulgaria, 1431 | |
| Research Site | |
| Sofia, Bulgaria, 1606 | |
| Research Site | |
| Varna, Bulgaria, 9010 | |
| Research Site | |
| Veliko Tarnovo, Bulgaria, 5000 | |
| Canada, Alberta | |
| Research Site | |
| Calgary, Alberta, Canada, T2E 7C5 | |
| Research Site | |
| Edmonton, Alberta, Canada, T6K 4C1 | |
| Research Site | |
| Edmonton, Alberta, Canada, T6G 2B7 | |
| Canada, British Columbia | |
| Research Site | |
| Campbell River, British Columbia, Canada, V9W 5Y4 | |
| Research Site | |
| 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, M1E 5E9 | |
| Research Site | |
| Scarborough, Ontario, Canada, M1P 2V5 | |
| 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, H3A 1A1 | |
| 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, H3G 1A4 | |
| 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 | |
| Research Site | |
| Santiago, Chile, 8330032 | |
| Research Site | |
| Santiago, Chile, 7500922 | |
| Research Site | |
| Santiago, Chile, 8320000 | |
| 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, 10138 | |
| Research Site | |
| Tallinn, Estonia, 10617 | |
| 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, 1106 | |
| Research Site | |
| Budapest, Hungary, 1096 | |
| Research Site | |
| Budapest, Hungary, 1135 | |
| Research Site | |
| Budapest, Hungary, 1075 | |
| Research Site | |
| Budapest, Hungary, 1027 | |
| 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, 110 025 | |
| Research Site | |
| New Delhi, Delhi, India, 110 029 | |
| 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, 411 016 | |
| 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, 411 006 | |
| 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, 49155 | |
| Research Site | |
| Kaunas, Lithuania, 50009 | |
| Research Site | |
| Kaunas, Lithuania, 44320 | |
| Research Site | |
| Klaipeda, Lithuania, 92288 | |
| Research Site | |
| Siauliai, Lithuania, 76231 | |
| Research Site | |
| Vilnius, Lithuania, 08314 | |
| Research Site | |
| Vilnius, Lithuania, 01113 | |
| Research Site | |
| Vilnius, Lithuania, 10309 | |
| Research Site | |
| Vilnius, Lithuania, 08661 | |
| 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, 04-628 | |
| Research Site | |
| Warszawa, Poland, 03-242 | |
| Research Site | |
| Warszawa, Poland, 04-238 | |
| Research Site | |
| Warszawa, Poland, 01-809 | |
| Research Site | |
| Warszawa, Poland, 01-211 | |
| 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, 030171 | |
| Research Site | |
| Bucuresti, Romania, 021659 | |
| Research Site | |
| Bucuresti, Romania, 011461 | |
| 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, 121552 | |
| Research Site | |
| Moscow, Russian Federation, 119992 | |
| Research Site | |
| Moscow, Russian Federation, 127018 | |
| Research Site | |
| Moscow, Russian Federation, 109263 | |
| Research Site | |
| Moscow, Russian Federation, 127473 | |
| Research Site | |
| Moscow, Russian Federation, 117292 | |
| Research Site | |
| Moscow, Russian Federation, 115516 | |
| 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, 129090 | |
| 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, 08036 | |
| Research Site | |
| Barcelona, Cataluña, Spain, 08035 | |
| Research Site | |
| Barcelona, Cataluña, Spain, 08003 | |
| Research Site | |
| Barcelona, Cataluña, Spain, 08041 | |
| 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, 28041 | |
| Research Site | |
| Madrid, Spain, 28046 | |
| Research Site | |
| Madrid, Spain, 28034 | |
| 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:
Publications:
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 |
| Last Updated: | January 24, 2013 |
| 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 Hematologic Diseases Heart Diseases |
Darbepoetin alfa Hematinics Hematologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 17, 2013