Aranesp®

Generic Name: darbepoetin alfa
Study IDStudied Indication or DiseasePhaseStudy TitleSynopsis
20000219Anemia of cancer2

A Randomized, Open-label, Comparative Study to Estimate the Effect of Darbepoetin alfa on Hospital Days, Economic Outcomes, and Health-related  Quality of Life in Subjects with Nonmyeloid Malignancies and Anemia of Cancer

20010103anemia of cancer3Results from a phase 3, randomized, double-blind, placebo-controlled study of darbepoetin alfa for the treatment of anemia in patients with active cancer not receiving chemotherapy or radiotherapy
20010145Previously Untreated Extensive-Stage Small-Cell Lung Cancer (SCLC)3

A Randomizd Double Blind, Placebo-Controlled Study of Subject With Previously Untreated Extensive-Stage Small-Cell Lung Cancer (SCLC) Treated With Platinum plus Etoposide Chemotherapy with or without darbepoetin alfa

20010184Treatment of anemia in subjects with chronic kidney3

Trial to Reduce Cardiovascular Events with Aranesp® Therapy (TREAT)

20020149Treatment of anemia of cancer in subjects who are not receiving chemotherapy3A Multicenter, Double-blind, Placebo-controlled Roll over Study to Protocol 20010103 of Darbepoetin Alfa for the Treatment of Anemia of Cancer
20030199Treatment of anemia associated with Chronic Renal Failure (CRF)4Retrospective Chart EValuatIon of Epoetin alfa to Aranesp® (darbepoetin alfa) Conversion Within Hemodialysis Centers (REVIEW)
20030204Anemia of Cancer2A Phase 2, Randomized, Double-blind, Placebo-controlled Study of Darbepoetin Alfa Administered Once Every 4 Weeks in the Treatment of Subjects with Anemia of Cancer.
20030237Chronic Kidney Disease Not Receiving Dialysis3A Multicenter, Single-arm Study Evaluating de Novo Once Every Two Week Darbepoetin alfa Dosing in Subjects With Chronic Kidney Disease Not Receiving Dialysis.
20040104Treatment of anemia in patients with chronic kidney disease (CKD)3Randomized, Double-Blind, Equivalence Study of the Efficacy of Darbepoetin Alfa Manufactured by Serum Free Bioreactor Technology and Darbepoetin Alfa Manufactured by Roller-Bottle Technology for the Treatment of Anemia in Patients with Chronic Kidney Disease Receiving Hemodialysis
20040137Breast Cancer2

An Open-label Phase 2 Study of Doxorubicin and Cyclophosphamide Followed by Paclitaxel (AC-T) Delivered Every 14 Days with Pegfilgrastim and Darbepoetin Alfa Support for the Adjuvant Treatment of Women with Breast Cancer

20040156Chemotherapy Induced Anemia3bA Randomized Open-Label Study of Darbepoetin alfa Administered Every Three Weeks with or without Parenteral Iron in Anemic Subjects with Nonmyeloid Malignancies Receiving Chemotherapy
20040168Chronic Kidney Disease Not on Dialysis1A Single Dose, Open-Label Study to Assess the Pharmacokinetics of Darbepoetin alfa in Subjects with Chronic Kidney Disease Not on Dialysis Following Subcutaneous Administration.
20040173Chronic hemodialysis, transfusion avoidance in the Intensive Care Unit (ICU), and surgery-related anemia in hospitalized patients4A Multicenter, Retrospective, Observational Study to Evaluate Erythropoietic Stimulating Protein (ESP) Use and Clinical Outcomes in Hospitalized Patients (ASSESS)
20040180Chronic Kidney Disease3An Open-Label, Single-Arm Study to Assess the Safety of Darbepoetin Alfa Manufactured by a Serum Free Bioreactor Technology in Subjects with Chronic Kidney Disease.
20040202Chronic Kidney Disease Receiving Dialysis3A Multicenter, Single Arm Study Evaluating Once Monthly Darbepoetin alfa Dosing in Subjects With Chronic Kidney Disease Receiving Dialysis
20040218Treatment of anaemia in patients with Chronic Kidney Disease (CKD) receiving haemodialysis (HD).3bStudy to Evaluate the Efficacy of Converting from Intravenous or Subcutaneous rHuEPO to Intravenous Darbepoetin Alfa (Aranesp®) in Subjects with Chronic Kidney Disease Receiving Haemodialysis
20040232Anemia2An Open-label, Single-arm Study to Evaluate the Pharmacokinetics,Pharmacodynamics, and Safety of Darbepoetin Alfa Administered Three Times per Week for the Treatment of Anemia in Subjects with Non-myeloid Malignancies Receiving Multicycle Chemotherapy.
20040262Anemia due to chemotherapy2Flexibility: A study to assess the impact of once per cycle correction and maintenance dosing of darbepoetin alfa in subjects with non-myeloid malignancies with anemia due to chemotherapy.
20040263Cancer patientsObservational StudyThe IMPACT Study: A Cluster-randomized Trial to Evaluate the Effect of an e/Tablet System on Quality of Care as Measured by Symptom Severity Assessment of Cancer Patients Receiving Chemotherapy (IMPACT: Improving the Management of Patient Assessment and Care using Technology.
20050122Anaemia in elderly subjects with chronic kidney (CKD)3b

A Randomised Single-Blind Study to Improve Health-related Quality of Life as Measured by the SF-36 Vitality Score by Correcting Anaemia of Chronic Kidney Disease with Aranesp® (darbepoetin alfa) in the Elderly (STIMULATE) 

20050125Treatment of anaemia in patients with chronic kidney disease (CKD) receiving dialysis4ALTERNATE: A Long Term Non-interventional Study to Evaluate the Effectiveness of Aranesp® in Dialysis Patients when Administered Once Every Two Weeks
20050210Treatment of anemia in KCD subjects receiving dialisis3A multicenter, single-arm study evaluating the extension from weekly to once every other week darbepoetin alfa administration in subjects with chronic kidney disease receiving dialysis
20050222Subjects with heart failure who have symptomatic left3

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

20050239Chronic kidney disease and anemia4

A Prospective Observational Study to Evaluate Physical Performance and Quality of Life in Older Long Stay Nursing Home Residents with Chronic Kidney Disease with and without Anemia

20050256Pediatric Subjects With Chronic Kidney Disease Receiving and Not Receiving Dialysis3

Multicenter, Double-blind, Randomized Study Evaluating De Novo Weekly and Once Every 2 Week Darbepoetin alfa Dosing for the Correction of Anemia in Pediatric Subjects With Chronic Kidney Disease Receiving and Not Receiving Dialysis

20060103Anemia with Darbepoetin alfa with Iron in Subjects2

Once per Cycle Treatment of Anemia With Darbepoetin alfa With Iron in Subjects With Non-myeloid Malignancies

20060163Treatment of anemia in subjects with chronic kidney3

A Multicenter, Randomized, Double-blind Study Comparing De Novo Once Monthly and Once Every 2 Week Darbepoetin alfa Dosing for the Correction of Anemia in Subjects With Chronic Kidney Disease Not Receiving Dialysis

20060172Anemia3Double-blind, Placebo Controlled, Multicenter Study to Assess the Effect of Darbepoetin alfa Treatment on Cardiac Function and Disease Specific Biomarkers in Subjects with Symptomatic Left Ventricular Systolic Dysfunction and Anemia: An Exploratory Sub-study for the RED-HF™; (Reduction of Events with Darbepoetin alfa in Heart Failure) Trial.
20060336Use of Aranesp in NephrologyObservationalCentral European Retrospective/Prospective Observational Study: Use of DA in Nephrology
20060426Anaemia of chronic kidney disease (CKD)4An observational cohort study of extended dosing (Q2W or QM) with Aranesp® s.c. in subjects with Chronic Kidney Disease not on dialysis (EXTEND)
20060428Elderly Dialysis PatientsObservationalElderly Dialysis Patients (>= 60 years): Characteristics, Demographics, Level of Care and Dialysis Effectiveness Parameters. Follow-up Report of a Multicenter Non-Interventional Study
20070065Treatment of anemia in dialysis-dependent patients with chronic renal failureObservationalSurvey to assess Continuous achievement of the Hb target range under long-acting Erythropoietic stimulation with Aranesp® in the treatment of renal anemia in dialysis patients
20070253Chronic Kidney Disease4A prospective cohort study of perceived satisfaction with prefilled pens (SureClickTM) for anemia treatment, compared with prefilled syringes, in Spanish chronic kidney disease patients not undergoing dialysis (PREFERENCE Study)
20070340Haemoglobin Levels in Cancer4Current Practice of Aranesp in the Management of Haemoglobin Levels: an Observational International Cancer Evaluation (CHOICE.
20070738Treatment of anemia in dialysis-dependent patients with chronic renal failureObservational

Survey to assess CONTINUous achievement of the Hb target range under long-acting Erythropoietic stimulation with Aranesp® in the treatment of renal anemia in dialysis patients

20080599Chronic Kidney Disease (CKD)ObservationalSIN-SIR Multiple Result Indicators Study (Epidemiology of Chronic Kidney Disease in Italy)
20090160Anemia3A Multicenter, Randomised, Double-blind, Placebo-controlled Study of Darbepoetin alfa for the Treatment of Anaemic Subjects With Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS).
20090240Anaemia 4Anaemia Prevalence and Treatment Practice in Subjects With Nonmyeloid Tumours Who Are Receiving Chemotherapy.
20101123Symptomatic Chemotherapy-induced Anemia4

Electronic Assessment of Quality of Life in Patients With Symptomatic Chemotherapy-induced Anemia: An International Prospective Observational Study (eAQUA)

20110138Perception of Fatigue and Pain SurveyNAA Survey of Cancer Patients and Oncology Health Care Professionals on their Perception of Fatigue and Pain
20130113Anaemic Subjects With Myelodysplastic Syndrome3b

Single-arm, Companion Study to Myelodysplastic Syndrome (MDS) 20090160 Using Darbepoetin alfa for the Treatment of Anaemic Subjects With Myelodysplastic Syndrome.

20130301Chronic Kidney Disease not on DialysisObservational StudyADAPTATION: Observational Study of Correction of Anaemia with Darbepoetin Alfa at Monthly Dose Frequency in EU Patients with Chronic Kidney Disease not on Dialysis.