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Aranesp (Erythropoiesis Stimulating Protein) - Summary

 



ARANESP SUMMARY

Aranesp® is an erythropoiesis stimulating protein, closely related to erythropoietin, that is produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Aranesp® is a 165-amino acid protein that differs from recombinant human erythropoietin in containing 5 N-linked oligosaccharide chains, whereas recombinant human erythropoietin contains 3 chains1. The two additional N-glycosylation sites result from amino acid substitutions in the erythropoietin peptide backbone.

Aranesp® is indicated for the treatment of anemia associated with chronic renal failure, including patients on dialysis and patients not on dialysis, and for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitantly administered chemotherapy.


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NEWS HIGHLIGHTS

Media Articles Related to Aranesp (Erythropoiesis Stimulating Protein)

FDA approves extended dosing of Aranesp
Source: The Doctors Lounge - Hematology
FDA has approved every-3-week dosing of Aranesp (darbepoetin alfa) for treatment of chemotherapy - induced anemia.

AHA: Stroke, VTE More Common with Darbepoetin (CME/CE)
Source: MedPage Today Endocrinology [2009.11.17]
ORLANDO (MedPage Today) -- Treating patients with diabetes, kidney disease, and anemia with the colony stimulating factor darbepoetin (Aranesp) to improve their hemoglobin levels appears to cause more problems than it solves, researchers reported here.

Anemia Drugs May Cause Deadly Blood Clots (HealthDay)
Source: Y! Health News Search RSS Feed [2009.11.10]
HealthDay - TUESDAY, Nov. 10 (HealthDay News) -- New research on cancer patients adds to the controversy surrounding anemia drugs such as Procrit and Aranesp, concluding that they increase the risk of venous thromboembolism, potentially fatal blood clots.

ASN: No Clinical Benefit for ESA in Anemic Patients with Diabetes, CKD (CME/CE)
Source: MedPage Today Endocrinology [2009.10.30]
SAN DIEGO (MedPage Today) -- For patients with type 2 diabetes, chronic kidney disease, and anemia, darbepoetin alfa (Aranesp) failed to improve most clinical outcomes compared with placebo and nearly doubled the risk of stroke, a large, multicenter trial showed.

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Published Studies Related to Aranesp (Erythropoiesis Stimulating Protein)

Baseline characteristics in the Trial to Reduce Cardiovascular Events With Aranesp Therapy (TREAT). [2009.07]
BACKGROUND: Anemia augments the already high rates of fatal and major nonfatal cardiovascular and renal events in individuals with type 2 diabetes. In 2004, we initiated the Trial to Reduce Cardiovascular Events With Aranesp Therapy (TREAT). This report presents the baseline characteristics and therapies of TREAT participants and subgroups defined by the presence or absence of overt proteinuria and history of cardiovascular disease. The design of TREAT and baseline characteristics also are compared with 2 recent trials of nondialysis patients with chronic kidney disease (CKD) in which treatment with another erythropoiesis-stimulating agent targeting greater hemoglobin levels had either a neutral or adverse effect on clinical outcomes... CONCLUSIONS: With several-fold more patient-years and a placebo arm, TREAT will provide a robust estimate of the safety and efficacy of darbepoetin alfa and generate prospective data regarding the risks of major cardiovascular and renal events in a contemporarily managed cohort of patients with type 2 diabetes, CKD, and anemia.

Challenge of effectively using erythropoiesis-stimulating agents and intravenous iron. [2008.12]
Clinicians who manage anemia in patients with chronic kidney disease, both on and off dialysis therapy, face several challenges: maintain stable hemoglobin (Hb) levels in their patients, avoid overshooting Hb targets, balance intravenous (IV) iron and erythropoiesis-stimulating agents (ESAs), and improve ESA response to use the lowest effective ESA dose...

Effect of intravenous iron sucrose in peritoneal dialysis patients who receive erythropoiesis-stimulating agents for anemia: a randomized, controlled trial. [2006.05]
Although iron therapy is essential to optimize use of erythropoiesis-stimulating agents (ESA), randomized, controlled trials have heretofore been unavailable to evaluate reliably the efficacy of intravenous iron as an adjuvant to ESA treatment in peritoneal dialysis (PD) patients...

Rationale--Trial to Reduce Cardiovascular Events with Aranesp Therapy (TREAT): evolving the management of cardiovascular risk in patients with chronic kidney disease. [2005.03]
BACKGROUND: Patients with chronic kidney disease (CKD) have a high burden of mortality and cardiovascular morbidity... TREAT will provide data that are critical to evolution of the management of cardiovascular risk in this high-risk population.

Novel erythropoiesis stimulating protein for treatment of anemia in chronic renal insufficiency. [2001.08]
BACKGROUND: Novel erythropoiesis stimulating protein (NESP) is a glycoprotein with a threefold longer terminal half-life than recombinant human erythropoietin (rHuEPO) in humans. The aim of this study was to determine whether NESP is effective for the treatment of anemia at a reduced dosing frequency relative to rHuEPO in patients with chronic renal failure not yet on dialysis [chronic renal insufficiency (CRI)]... CONCLUSIONS: These results demonstrate that NESP safely and effectively corrects and maintains hemoglobin concentrations at a reduced dosing frequency relative to rHuEPO in patients with CRI, providing a potential benefit to patients and health care providers.

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Clinical Trials Related to Aranesp (Erythropoiesis Stimulating Protein)

An Evaluation of Aranesp® in Subjects With Anaemic Chronic Kidney Disease (CKD) [Completed]
The purpose of this study is to assess if Aranesp® administered once every 4 weeks to chronic kidney disease subjects is safe and efficacious in maintaining haemoglobin levels greater than or equal to 100 g/L.

A Dose Finding Study of KRN321(Darbepoetin Alfa) for the Treatment of Anemia in Subjects With Solid Tumor [Completed]
To assess the clinical effective dose of KRN321 administered with once triweekly schedule.

Darbepoetin Alfa (Aranesp) Following Allogeneic Stem Cell Transplantation [Completed]
The purpose of this study is to find out if Darbepoetin alfa is effective in treating low red blood cell levels after allogeneic stem cell transplant. Darbepoetin alfa has been shown to help raise red blood cell levels without blood transfusions.

Study of Aranesp to Treat Anemia in Prostate Cancer Patients. [Completed]
The purpose of this study is to see if darbepoetin alfa is an effective treatment for anemia in prostate cancer patients and, if so, what dose is most effective. Sometimes prostate cancer patients have low red blood cell counts (low hemoglobin) from various treatments they are receiving, such as chemotherapy. The red blood cells deliver oxygen to the tissue. This then helps give the patient more energy.

Evaluation of Iron Supplementation During Darbepoetin Alfa Treatment in Prophylaxis of Severe Anaemia Chemo-Induced [Terminated]
The purpose of this study is to evaluate the response rate obtained in an heterogeneous oncologic population treated by chemotherapy, and either by Darbepoetin alfa classic

treatment or by association of Darbepoetin alfa - ferric saccharose systematic

supplementation, administered concomitantly with chemotherapy.

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Page last updated: 2009-11-17

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