Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2025-12-28 @ 12:55 AM
Study NCT ID:
NCT01039350
Status:
TERMINATED
Last Update Posted:
2010-01-13
First Post:
2009-12-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective, Multicenter, Open Label and Single-arm Study of Darbepoetin Alfa for Anemia in Myelodisplastic Syndrome Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}], 'ancestors': [{'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068256', 'term': 'Darbepoetin alfa'}], 'ancestors': [{'id': 'D004921', 'term': 'Erythropoietin'}, {'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'whyStopped': 'It was stopped due to a lack of recruitment after 48 patients included', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-01', 'completionDateStruct': {'date': '2009-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-01-12', 'studyFirstSubmitDate': '2009-12-23', 'studyFirstSubmitQcDate': '2009-12-23', 'lastUpdatePostDateStruct': {'date': '2010-01-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients achieving an erythroid response during the 24-week treatment period.', 'timeFrame': 'weeks 8; 12; 16 and 24'}], 'secondaryOutcomes': [{'measure': 'Time to erythroid response and time it is maintained.', 'timeFrame': 'week 24'}, {'measure': 'Proportion of non-responders to darbepoetin alfa who obtain an erythroid response after the addition of Filgrastim', 'timeFrame': 'weeks 8, 12, 16 and 24'}, {'measure': 'Proportion of patients receiving RBC transfusions (more than 1 unit) from week 5 to 24, inclusive', 'timeFrame': 'weeks 8; 12; 16 and 24'}, {'measure': 'Score changes in the FACT-Fatigue quality-of-life scale between the baseline visit, and weeks 8, 16, 24, and the end of the study.', 'timeFrame': 'weeks 8; 16 and 24'}, {'measure': 'Number of morphological and cytogenetic disorders at baseline and end of treatment', 'timeFrame': 'week 24'}, {'measure': 'Incidence of adverse events and serious adverse events', 'timeFrame': 'weeks 8; 12; 16 and 24'}, {'measure': 'Proportion of patients with haemoglobin values over 12 g/dL at any time during the study', 'timeFrame': 'weeks 8; 12; 16 and 24'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Myelodysplastic syndrome'], 'conditions': ['Myelodysplastic Syndrome']}, 'referencesModule': {'references': [{'pmid': '6952920', 'type': 'BACKGROUND', 'citation': 'Bennett JM, Catovsky D, Daniel MT, Flandrin G, Galton DA, Gralnick HR, Sultan C. Proposals for the classification of the myelodysplastic syndromes. Br J Haematol. 1982 Jun;51(2):189-99.'}, {'pmid': '11698274', 'type': 'BACKGROUND', 'citation': 'Nosslinger T, Reisner R, Koller E, Gruner H, Tuchler H, Nowotny H, Pittermann E, Pfeilstocker M. Myelodysplastic syndromes, from French-American-British to World Health Organization: comparison of classifications on 431 unselected patients from a single institution. Blood. 2001 Nov 15;98(10):2935-41. doi: 10.1182/blood.v98.10.2935.'}, {'pmid': '9058730', 'type': 'BACKGROUND', 'citation': 'Greenberg P, Cox C, LeBeau MM, Fenaux P, Morel P, Sanz G, Sanz M, Vallespi T, Hamblin T, Oscier D, Ohyashiki K, Toyama K, Aul C, Mufti G, Bennett J. International scoring system for evaluating prognosis in myelodysplastic syndromes. Blood. 1997 Mar 15;89(6):2079-88.'}, {'pmid': '11276043', 'type': 'BACKGROUND', 'citation': 'Littlewood TJ. Erythropoietin for the treatment of anemia associated with hematological malignancy. Hematol Oncol. 2001 Mar;19(1):19-30. doi: 10.1002/hon.663.'}, {'pmid': '12160363', 'type': 'BACKGROUND', 'citation': 'Molldrem JJ, Leifer E, Bahceci E, Saunthararajah Y, Rivera M, Dunbar C, Liu J, Nakamura R, Young NS, Barrett AJ. Antithymocyte globulin for treatment of the bone marrow failure associated with myelodysplastic syndromes. Ann Intern Med. 2002 Aug 6;137(3):156-63. doi: 10.7326/0003-4819-137-3-200208060-00007.'}, {'pmid': '11493439', 'type': 'BACKGROUND', 'citation': 'Raza A, Meyer P, Dutt D, Zorat F, Lisak L, Nascimben F, du Randt M, Kaspar C, Goldberg C, Loew J, Dar S, Gezer S, Venugopal P, Zeldis J. Thalidomide produces transfusion independence in long-standing refractory anemias of patients with myelodysplastic syndromes. Blood. 2001 Aug 15;98(4):958-65. doi: 10.1182/blood.v98.4.958.'}, {'pmid': '10233377', 'type': 'BACKGROUND', 'citation': 'Stasi R, Pagano A, Terzoli E, Amadori S. Recombinant human granulocyte-macrophage colony-stimulating factor plus erythropoietin for the treatment of cytopenias in patients with myelodysplastic syndromes. Br J Haematol. 1999 Apr;105(1):141-8.'}, {'pmid': '8639764', 'type': 'BACKGROUND', 'citation': 'Negrin RS, Stein R, Doherty K, Cornwell J, Vardiman J, Krantz S, Greenberg PL. Maintenance treatment of the anemia of myelodysplastic syndromes with recombinant human granulocyte colony-stimulating factor and erythropoietin: evidence for in vivo synergy. Blood. 1996 May 15;87(10):4076-81.'}, {'pmid': '1483451', 'type': 'BACKGROUND', 'citation': 'Koury MJ, Bondurant MC. The molecular mechanism of erythropoietin action. Eur J Biochem. 1992 Dec 15;210(3):649-63. doi: 10.1111/j.1432-1033.1992.tb17466.x. No abstract available.'}, {'pmid': '12437640', 'type': 'BACKGROUND', 'citation': "Rigolin GM, Porta MD, Bigoni R, Cavazzini F, Ciccone M, Bardi A, Cuneo A, Castoldi G. rHuEpo administration in patients with low-risk myelodysplastic syndromes: evaluation of erythroid precursors' response by fluorescence in situ hybridization on May-Grunwald-Giemsa-stained bone marrow samples. Br J Haematol. 2002 Dec;119(3):652-9. doi: 10.1046/j.1365-2141.2002.03867.x."}, {'pmid': '9639501', 'type': 'BACKGROUND', 'citation': 'Hellstrom-Lindberg E, Ahlgren T, Beguin Y, Carlsson M, Carneskog J, Dahl IM, Dybedal I, Grimfors G, Kanter-Lewensohn L, Linder O, Luthman M, Lofvenberg E, Nilsson-Ehle H, Samuelsson J, Tangen JM, Winqvist I, Oberg G, Osterborg A, Ost A. Treatment of anemia in myelodysplastic syndromes with granulocyte colony-stimulating factor plus erythropoietin: results from a randomized phase II study and long-term follow-up of 71 patients. Blood. 1998 Jul 1;92(1):68-75.'}, {'pmid': '10586205', 'type': 'BACKGROUND', 'citation': 'Remacha AF, Arrizabalaga B, Villegas A, Manteiga R, Calvo T, Julia A, Fernandez Fuertes I, Gonzalez FA, Font L, Junca J, del Arco A, Malcorra JJ, Equiza EP, de Mendiguren BP, Romero M. Erythropoietin plus granulocyte colony-stimulating factor in the treatment of myelodysplastic syndromes. Identification of a subgroup of responders. The Spanish Erythropathology Group. Haematologica. 1999 Dec;84(12):1058-64.'}, {'pmid': '10666187', 'type': 'BACKGROUND', 'citation': 'Thompson JA, Gilliland DG, Prchal JT, Bennett JM, Larholt K, Nelson RA, Rose EH, Dugan MH. Effect of recombinant human erythropoietin combined with granulocyte/ macrophage colony-stimulating factor in the treatment of patients with myelodysplastic syndrome. GM/EPO MDS Study Group. Blood. 2000 Feb 15;95(4):1175-9.'}, {'pmid': '11137555', 'type': 'BACKGROUND', 'citation': 'Hast R, Wallvik J, Folin A, Bernell P, Stenke L. Long-term follow-up of 18 patients with myelodysplastic syndromes responding to recombinant erythropoietin treatment. Leuk Res. 2001 Jan;25(1):13-18. doi: 10.1016/s0145-2126(00)00073-4.'}, {'pmid': '9886322', 'type': 'BACKGROUND', 'citation': 'Italian Cooperative Study Group for rHuEpo in Myelodysplastic Syndromes; Ferrini PR, Grossi A, Vannucchi AM, Barosi G, Guarnone R, Piva N, Musto P, Balleari E. A randomized double-blind placebo-controlled study with subcutaneous recombinant human erythropoietin in patients with low-risk myelodysplastic syndromes. Br J Haematol. 1998 Dec;103(4):1070-4. doi: 10.1046/j.1365-2141.1998.01085.x.'}, {'pmid': '12100145', 'type': 'BACKGROUND', 'citation': 'Terpos E, Mougiou A, Kouraklis A, Chatzivassili A, Michalis E, Giannakoulas N, Manioudaki E, Lazaridou A, Bakaloudi V, Protopappa M, Liapi D, Grouzi E, Parharidou A, Symeonidis A, Kokkini G, Laoutaris NP, Vaipoulos G, Anagnostopoulos NI, Christakis JI, Meletis J, Bourantas KL, Zoumbos NC, Yataganas X, Viniou NA; Greek MDS Study Group. Prolonged administration of erythropoietin increases erythroid response rate in myelodysplastic syndromes: a phase II trial in 281 patients. Br J Haematol. 2002 Jul;118(1):174-80. doi: 10.1046/j.1365-2141.2002.03583.x.'}, {'pmid': '7833279', 'type': 'BACKGROUND', 'citation': 'Hellstrom-Lindberg E. Efficacy of erythropoietin in the myelodysplastic syndromes: a meta-analysis of 205 patients from 17 studies. Br J Haematol. 1995 Jan;89(1):67-71. doi: 10.1111/j.1365-2141.1995.tb08909.x.'}, {'pmid': '10848827', 'type': 'BACKGROUND', 'citation': 'Mantovani L, Lentini G, Hentschel B, Wickramanayake PD, Loeffler M, Diehl V, Tesch H. Treatment of anaemia in myelodysplastic syndromes with prolonged administration of recombinant human granulocyte colony-stimulating factor and erythropoietin. Br J Haematol. 2000 May;109(2):367-75. doi: 10.1046/j.1365-2141.2000.02016.x.'}, {'pmid': '15054036', 'type': 'BACKGROUND', 'citation': 'Casadevall N, Durieux P, Dubois S, Hemery F, Lepage E, Quarre MC, Damaj G, Giraudier S, Guerci A, Laurent G, Dombret H, Chomienne C, Ribrag V, Stamatoullas A, Marie JP, Vekhoff A, Maloisel F, Navarro R, Dreyfus F, Fenaux P. Health, economic, and quality-of-life effects of erythropoietin and granulocyte colony-stimulating factor for the treatment of myelodysplastic syndromes: a randomized, controlled trial. Blood. 2004 Jul 15;104(2):321-7. doi: 10.1182/blood-2003-07-2252. Epub 2004 Mar 30.'}, {'pmid': '11090046', 'type': 'BACKGROUND', 'citation': 'Cheson BD, Bennett JM, Kantarjian H, Pinto A, Schiffer CA, Nimer SD, Lowenberg B, Beran M, de Witte TM, Stone RM, Mittelman M, Sanz GF, Wijermans PW, Gore S, Greenberg PL; World Health Organization(WHO) international working group. Report of an international working group to standardize response criteria for myelodysplastic syndromes. Blood. 2000 Dec 1;96(12):3671-4.'}, {'pmid': '12648074', 'type': 'BACKGROUND', 'citation': 'Hellstrom-Lindberg E, Gulbrandsen N, Lindberg G, Ahlgren T, Dahl IM, Dybedal I, Grimfors G, Hesse-Sundin E, Hjorth M, Kanter-Lewensohn L, Linder O, Luthman M, Lofvenberg E, Oberg G, Porwit-MacDonald A, Radlund A, Samuelsson J, Tangen JM, Winquist I, Wisloff F; Scandinavian MDS Group. A validated decision model for treating the anaemia of myelodysplastic syndromes with erythropoietin + granulocyte colony-stimulating factor: significant effects on quality of life. Br J Haematol. 2003 Mar;120(6):1037-46. doi: 10.1046/j.1365-2141.2003.04153.x.'}, {'pmid': '11308268', 'type': 'BACKGROUND', 'citation': 'Egrie JC, Browne JK. Development and characterization of novel erythropoiesis stimulating protein (NESP). Br J Cancer. 2001 Apr;84 Suppl 1(Suppl 1):3-10. doi: 10.1054/bjoc.2001.1746.'}, {'pmid': '11953669', 'type': 'BACKGROUND', 'citation': 'Smith R. Applications of darbepoietin-alpha, a novel erythropoiesis-stimulating protein, in oncology. Curr Opin Hematol. 2002 May;9(3):228-33. doi: 10.1097/00062752-200205000-00009.'}, {'pmid': '10541299', 'type': 'BACKGROUND', 'citation': 'Macdougall IC, Gray SJ, Elston O, Breen C, Jenkins B, Browne J, Egrie J. Pharmacokinetics of novel erythropoiesis stimulating protein compared with epoetin alfa in dialysis patients. J Am Soc Nephrol. 1999 Nov;10(11):2392-5. doi: 10.1681/ASN.V10112392.'}, {'pmid': '12957457', 'type': 'BACKGROUND', 'citation': 'Kotasek D, Steger G, Faught W, Underhill C, Poulsen E, Colowick AB, Rossi G, Mackey J; Aranesp 980291 Study Group. Darbepoetin alfa administered every 3 weeks alleviates anaemia in patients with solid tumours receiving chemotherapy; results of a double-blind, placebo-controlled, randomised study. Eur J Cancer. 2003 Sep;39(14):2026-34. doi: 10.1016/s0959-8049(03)00456-8.'}, {'pmid': '9375752', 'type': 'BACKGROUND', 'citation': 'Hellstrom-Lindberg E, Negrin R, Stein R, Krantz S, Lindberg G, Vardiman J, Ost A, Greenberg P. Erythroid response to treatment with G-CSF plus erythropoietin for the anaemia of patients with myelodysplastic syndromes: proposal for a predictive model. Br J Haematol. 1997 Nov;99(2):344-51. doi: 10.1046/j.1365-2141.1997.4013211.x.'}, {'pmid': '12177793', 'type': 'BACKGROUND', 'citation': "Glaspy JA, Jadeja JS, Justice G, Kessler J, Richards D, Schwartzberg L, Tchekmedyian NS, Armstrong S, O'Byrne J, Rossi G, Colowick AB. Darbepoetin alfa given every 1 or 2 weeks alleviates anaemia associated with cancer chemotherapy. Br J Cancer. 2002 Jul 29;87(3):268-76. doi: 10.1038/sj.bjc.6600465."}, {'pmid': '15638854', 'type': 'BACKGROUND', 'citation': 'Musto P, Lanza F, Balleari E, Grossi A, Falcone A, Sanpaolo G, Bodenizza C, Scalzulli PR, La Sala A, Campioni D, Ghio R, Cascavilla N, Carella AM. Darbepoetin alpha for the treatment of anaemia in low-intermediate risk myelodysplastic syndromes. Br J Haematol. 2005 Jan;128(2):204-9. doi: 10.1111/j.1365-2141.2004.05288.x.'}, {'pmid': '16681638', 'type': 'BACKGROUND', 'citation': 'Mannone L, Gardin C, Quarre MC, Bernard JF, Vassilieff D, Ades L, Park S, Vaultier S, Hamza F, Beyne-rauzy MO, Cheze S, Giraudier S, Agape P, Legros L, Voillat L, Dreyfus F, Fenaux P; Groupe Francais des Myelodysplasies. High-dose darbepoetin alpha in the treatment of anaemia of lower risk myelodysplastic syndrome results of a phase II study. Br J Haematol. 2006 Jun;133(5):513-9. doi: 10.1111/j.1365-2141.2006.06070.x.'}, {'pmid': '12189224', 'type': 'BACKGROUND', 'citation': 'Vansteenkiste J, Pirker R, Massuti B, Barata F, Font A, Fiegl M, Siena S, Gateley J, Tomita D, Colowick AB, Musil J; Aranesp 980297 Study Group. Double-blind, placebo-controlled, randomized phase III trial of darbepoetin alfa in lung cancer patients receiving chemotherapy. J Natl Cancer Inst. 2002 Aug 21;94(16):1211-20. doi: 10.1093/jnci/94.16.1211.'}, {'pmid': '12877666', 'type': 'BACKGROUND', 'citation': 'Hedenus M, Adriansson M, San Miguel J, Kramer MH, Schipperus MR, Juvonen E, Taylor K, Belch A, Altes A, Martinelli G, Watson D, Matcham J, Rossi G, Littlewood TJ; Darbepoetin Alfa 20000161 Study Group. Efficacy and safety of darbepoetin alfa in anaemic patients with lymphoproliferative malignancies: a randomized, double-blind, placebo-controlled study. Br J Haematol. 2003 Aug;122(3):394-403. doi: 10.1046/j.1365-2141.2003.04448.x.'}, {'pmid': '12799626', 'type': 'BACKGROUND', 'citation': 'Smith RE Jr, Tchekmedyian NS, Chan D, Meza LA, Northfelt DW, Patel R, Austin M, Colowick AB, Rossi G, Glaspy J. A dose- and schedule-finding study of darbepoetin alpha for the treatment of chronic anaemia of cancer. Br J Cancer. 2003 Jun 16;88(12):1851-8. doi: 10.1038/sj.bjc.6600994.'}, {'type': 'BACKGROUND', 'citation': 'Hellstrom-Lindberg E. Growth factor treatment for the anemia of MDS: mechanisms and efficacy. Educational Programme at the 8th Congress of the European Haematology Association (EHA), June 2003'}, {'type': 'BACKGROUND', 'citation': 'Verhoef GEG, Boogaerts MA. RHuEPO in the treatment of the myelodysplastic syndromes. In: Smyth JF, Boogaerts MA, Ehmer BR-M (eds): rHuEPO in cancer supportive treatment. Marcel Dekker, New York 1996;pp.13-34.'}, {'type': 'BACKGROUND', 'citation': 'Heatherington AC, Schuller J, Kotasek D, et al. The pharmacokinetics of darbepoetin alfa and changes in endogenous erythropoietin in patients with nonmyeloid malignancies receiving or not receiving chemotherapy. European Breast Cancer Conference (EBCC) 2002. Abstract.'}, {'type': 'BACKGROUND', 'citation': 'Glaspy J, Appelbaum S, Henry D et al. Effects of darbepoetin alfa (Aranesp®) timing with chemotherapy administration: a randomized study. SIOG 2003. Poster.'}, {'type': 'BACKGROUND', 'citation': 'WHO Classification Tumours of Haematopoietic and Lymphoid Tissues. IARC Press, Lyon 2001'}, {'pmid': '21381892', 'type': 'DERIVED', 'citation': 'Villegas A, Arrizabalaga B, Fernandez-Lago C, Castro M, Mayans JR, Gonzalez-Porras JR, Duarte RF, Remacha AF, Luno E, Gasquet JA. Darbepoetin alfa for anemia in patients with low or intermediate-1 risk myelodysplastic syndromes and positive predictive factors of response. Curr Med Res Opin. 2011 May;27(5):951-60. doi: 10.1185/03007995.2011.561834. Epub 2011 Mar 7.'}]}, 'descriptionModule': {'briefSummary': 'This is an open-label, single-arm, multicentre, prospective study of darbepoetin alfa to treat anaemia in patients with low and intermediate-1 IPSS risk MDS. The study will consist of a 14-day screening period followed by a maximum 24-week treatment period and a final visit.', 'detailedDescription': 'This is an open-label, single-arm, multicentre, prospective study of darbepoetin alfa to treat anaemia in patients with low and intermediate-1 IPSS risk MDS. The study will consist of a 14-day screening period followed by a maximum 24-week treatment period and a final visit. Darbepoetin alfa will be initiated at a dose of 300 mcg QW SC over a period of 8 weeks. After 8 weeks, erythroid response will be evaluated, and treatment algorithm adapted to it.\n\nThe study treatment period will last for a maximum of 24 weeks. The treatment will end at the start of week 24. If the scheduled 24-week treatment period is not completed, it will end during the week of the last administration of the study drug.\n\nThe follow-up period will last for a minimum of 4 weeks and a maximum of 8 weeks after the last dose of darbepoetin alfa.\n\nSubjects will be stratified at enrolment according to IPSS (low risk versus intermediate-1 risk).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ³ 18 years\n* Low or intermediate-1 risk MDS according to IPSS, and FAB classification of RA, RARS, or RAEB with blasts £ 10%\n* Predictive variables of good response (serum erythropoietin levels \\< 500 IU/l and transfusion requirements \\< 2 packed RBC/month over the preceding 2 months)\n* Anaemia (Hb £ 10 g/dL), confirmed in the 14 days before day 1 of the study\n* Life expectancy of at least 6 months\n* ECOG Performance status score of 0, 1, or 2\n* Subject must sign and date the Informed Consent (approved by a Clinical Research Ethics Committee - CREC), before any study-specific procedure is performed\n\nExclusion Criteria:\n\n* Known history of convulsive disorders\n* Poorly controlled hypertension (diastolic blood pressure \\> 100 mmHg) at screening\n* Inadequate liver function (total bilirubin \\> two times the upper limit of the normal range (ULN), and liver enzymes (ALT, AST) \\> two times ULN)\n* Inadequate renal function (serum creatinine concentration \\> 2 mg/dL)\n* Ferritin \\< 100 ng/ml or transferrin saturation index (TSI) \\< 16%; Vitamin B12 deficiency (\\< 200 pg/ml) or folate deficiency (\\< 2 ng/ml)\n* Clinically-relevant haemorrhages\n* Haemolytic anaemia\n* Cardiac condition: uncontrolled angina, congestive heart failure, or uncontrolled cardiac arrhythmia\n* Clinically significant systemic infection or chronic inflammatory disease present at time of screening\n* Any concomitant therapy used to treat MDS (including other growth factors than those described as part of this protocol, chemotherapy, antibody-based cancer treatment, hormonal therapy, interferon, and interleukins)\n* Treatment with rHuEPO or darbepoetin alfa over the 4 weeks prior to Day 1 of the study\n* More than 2 RBC transfusions over the 28 days prior to Day 1 of the study\n* Pregnant or breast feeding women\n* Subjects of childbearing-potential who do not take adequate contraceptive measures, in the opinion of the investigator\n* Known hypersensitivity to any mammal-derived recombinant product'}, 'identificationModule': {'nctId': 'NCT01039350', 'briefTitle': 'Prospective, Multicenter, Open Label and Single-arm Study of Darbepoetin Alfa for Anemia in Myelodisplastic Syndrome Patients.', 'organization': {'class': 'OTHER', 'fullName': 'Fundacion para el Estudio de la Hematologia y Hemoterapia en Aragon'}, 'officialTitle': 'Prospective, Multicenter, Open Label and Single-arm Study of Darbepoetin Alfa for Anemia in Myelodisplastic Syndrome Patients.', 'orgStudyIdInfo': {'id': 'GEE200401'}, 'secondaryIdInfos': [{'id': '2005-002414-38', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Darbepoetin alfa', 'type': 'DRUG', 'description': 'Darbepoetin alfa will be initiated at a weekly (QW) subcutaneous dose of 300 mcg over 8 weeks.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '03010', 'city': 'Alicante', 'state': 'Alicante', 'country': 'Spain', 'facility': 'Hospital General Universitario de Alicante', 'geoPoint': {'lat': 38.34517, 'lon': -0.48149}}, {'zip': '08025', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital de la Santa Creu i Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08035', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Vall D´Hebron', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08036', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clinic i Provincial de Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08907', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Duran i Reynals', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '48903', 'city': 'Barakaldo', 'state': 'Bilbao', 'country': 'Spain', 'facility': 'Hospital de Cruces', 'geoPoint': {'lat': 43.29639, 'lon': -2.98813}}, {'zip': '09005', 'city': 'Burgos', 'state': 'Burgos', 'country': 'Spain', 'facility': 'Hospital General Yagüe', 'geoPoint': {'lat': 42.34106, 'lon': -3.70184}}, {'zip': '10600', 'city': 'Plasencia', 'state': 'Caceres', 'country': 'Spain', 'facility': 'Hospital Virgen del Puerto', 'geoPoint': {'lat': 40.03116, 'lon': -6.08845}}, {'zip': '11009', 'city': 'Cadiz', 'state': 'Cádiz', 'country': 'Spain', 'facility': 'Hospital Universitario Puerta del Mar', 'geoPoint': {'lat': 36.52672, 'lon': -6.2891}}, {'zip': '15006', 'city': 'A Coruña', 'state': 'La Coruña', 'country': 'Spain', 'facility': 'Complejo Hospitalario Universitario Juan Canalejo', 'geoPoint': {'lat': 43.37135, 'lon': -8.396}}, {'zip': '28034', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Ramón y Cajal', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28041', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Doce de Octubre', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '33006', 'city': 'Oviedo', 'state': 'Principality of Asturias', 'country': 'Spain', 'facility': 'Hospital Central de Asturias', 'geoPoint': {'lat': 43.36029, 'lon': -5.84476}}, {'zip': '37007', 'city': 'Salamanca', 'state': 'Salamanca', 'country': 'Spain', 'facility': 'Hospital Universitario de Salamanca', 'geoPoint': {'lat': 40.96882, 'lon': -5.66388}}, {'zip': '46009', 'city': 'Valencia', 'state': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Universitario La Fé', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '46015', 'city': 'Valencia', 'state': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Arnau de Vilanova', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'overallOfficials': [{'name': 'Ana M Villegas, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fundacion para el Estudio de la Hematologia y Hemoterapia en Aragon'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundacion para el Estudio de la Hematologia y Hemoterapia en Aragon', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Ana M Villegas', 'oldOrganization': 'FEHH'}}}}