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OpenTrials
Completed

NCT Number: NCT00117039

A Study to Evaluate the Effectiveness of Aranesp® for Cancer Patients With Anemia

The purpose of this trial is to assess the effectiveness of Aranesp® administered at 300 mcg every 3 weeks (q3w) in achieving therapeutic objectives of anemia treatment (achieving and maintaining hemoglobin levels consistent with the National Comprehensive Cancer Network (NCCN) guidelines).

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Key information

Conditions

Anemia Fatigue Hematologic Diseases Hemic and Lymphatic Diseases Neoplasms Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

- Subjects with non-myeloid malignancy - Anemia (Hgb less than 11.0 g/dL) due to cancer chemotherapy - Receiving chemotherapy and expected to receive at least 8 additional weeks of chemotherapy - Adequate renal function - Adequate liver function Exclusion Criteria: - Subjects with acute myelogenous leukemia (AML), chronic myelogenous leukemia (CML), or myelodysplastic syndromes (MDS) - Unstable cardiac disease - Active bleeding - Active systemic or chronic infection - Severe active chronic inflammatory disease - Other hematologic disorder associated with anemia - Uncontrolled hypertension - Known iron or nutritional deficiency - Known positive test for human immunodeficiency virus (HIV) infection - History of pure red cell aplasia - History of positive antibody response to any erythropoietic agent - Erythropoietin therapy within 4 weeks before screening - RBC transfusions within 2 weeks prior to screening

Treatment and study plan

Aranesp®

Drug

Primary outcomes

  1. Hemoglobin maintenance

Secondary outcomes

  1. Quality of Life

  2. Changes in measures of work productivity and anemia treatment convenience

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

SYNCHRONICITY: A Study to Evaluate the Effectiveness of Aranesp® at 300 Mcg Q3W on Clinical Outcomes in Cancer Patients With Anemia Due to Chemotherapy

Important dates

Study start
2004
Study completion
2005
First posted
Jul 4, 2005
Registry last updated
Oct 15, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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