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Aranesp

Phase 3

Kidney Disease | Small molecule | Nephrology |Amgen Inc.|Last Updated: May 24, 2013

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials2
Total Enrollment200

FDA Designations

No designations recorded

Clinical trial landscape

Aranesp · 4 trials · 4 indications

Phase 3 2Phase 2 2
NCT00116701Treatment for Subjects With Chronic Kidney Disease Receiving HaemodialysisKidney Disease
COMPLETED200 Analytics
NCT00124098An Evaluation of Aranesp® in Subjects With Anaemic Chronic Kidney Disease (CKD)Kidney Disease
COMPLETED- Analytics
PHASE3COMPLETED
Treatment for Subjects With Chronic Kidney Disease Receiving Haemodialysis
Kidney DiseaseUnlock trial analytics
PHASE3COMPLETED
An Evaluation of Aranesp® in Subjects With Anaemic Chronic Kidney Disease (CKD)
Kidney DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Treatment period 1: Mean haemoglobin during the evaluation period (weeks 21-24)
Treatment period 2: Mean haemoglobin during evaluation period 2 (weeks 45-48)
Haemoglobin level
Hemoglobin greater than or equal to 12.5
Feb 2005
Change in hemoglobin (Hb) in chemotherapy induced anemia

Secondary Endpoints

Treatment period 2: Change in Hb between Evaluation Period 1 and Evaluation Period 2
Treatment period 2: The proportion of subjects with a change in Hb between Evaluation Period 1 and Evaluation Period 2 within the inclusive range -1.0 to +1.5 g/dL
Treatment period 2: The proportion of subjects with a mean Hb > 11.0 g/dL during Evaluation Period 2
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1ACTIVE_COMPARATORAranesp

Interventions

NameTypeDescription
Aranesp®DRUG -
Aranesp® (darbepoetin alfa)DRUG -
AranespDRUGAranesp
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: -at least 18 years old - Diagnosis of chronic kidney disease (CKD) and receiving dialysis for at least 3 months prior to screening - Baseline Hb level greater than or equal to 10.0 g/dL and less than or equal to 13.0 g/dL - Adequate iron stores (defined as serum ferritin greater ...

Countries:United States
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Frequently asked questions about Aranesp

What is Aranesp used for?

Aranesp is used for anemia associated with chronic kidney disease and chemotherapy-induced anemia in cancer patients. It has been studied in prostate cancer patients with anemia. Aranesp is developed by Amgen Inc. for these indications.

What does Aranesp target?

Aranesp targets the erythropoietin receptor, stimulating red blood cell production. It is a small molecule designed to treat anemia by promoting erythropoiesis. This mechanism addresses anemia in chronic kidney disease and cancer patients.

Who makes Aranesp?

Aranesp is developed by Amgen Inc., a biopharmaceutical company. Amgen's stock ticker is AMGN. The company has conducted clinical trials for Aranesp in kidney disease, anemia, and prostate cancer.

What phase is Aranesp in?

Aranesp is in Phase 2 clinical development for prostate cancer and anemia. It has completed Phase 3 trials for chronic kidney disease. The drug is investigational and not approved for these indications.

What clinical trials is Aranesp in?

Aranesp has completed trials including NCT00116701 and NCT00124098 for kidney disease, NCT00144131 for chemotherapy-induced anemia, and NCT00245895 for prostate cancer anemia. These trials enrolled a total of 750 patients.

Is Aranesp the same as darbepoetin alfa?

Yes, Aranesp is the brand name for darbepoetin alfa. Clinical trials such as NCT00144131 refer to darbepoetin alfa in their titles, confirming that Aranesp and darbepoetin alfa are the same drug.