EPO Deep Tank in Dialysis Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00156949
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : February 19, 2010
Information provided by:

Brief Summary:
Subject incidence of adverse events

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Drug: Epoetin alfa DT Phase 3

Detailed Description:
To determine whether Epoetin alfa manufactured by a roller bottle technology (Epoetin alfa RB) and Epoetin alfa manufactured by a deep tank process (Epoetin alfa DT) have comparable safety profiles when administered to patients with CKD receiving dialysis.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 580 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Single-Arm Study to Assess the Safety of Epoetin Alfa Manufactured by a Deep Tank Technology in Subjects With Chronic Kidney Disease Receiving Dialysis
Study Start Date : April 2005
Actual Primary Completion Date : February 2007
Actual Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: Epoetin alfa DT Drug: Epoetin alfa DT
Receive drug at same frequency and dose as at the time of randomization Change dose by+/- 25% in order to maintain Hb between 11.0 - 13.0 g/dL

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria: - ≥ 18 years of age - Receiving hemodialysis or peritoneal dialysis - Baseline Hb between 11.0 g/dL and 13.0 g/dL - Currently receiving Epoetin alfa RB ie. EPOGEN or PROCRIT - Transferrin saturation (Tsat) >15.0% Exclusion Criteria: - Currently receiving or ever received treatment with any erythropoietic stimulating protein other than EPOGEN, Procrit and Aranesp. - Uncontrolled hypertension (defined as diastolic blood pressure >110 mmHg or systolic BP >180 mmHg during screening). - Grand mal seizure within the last 6 months prior to screening. - Acute myocardial ischemia; hospitalization for congestive heart failure or myocardial infarction within 12 weeks before enrollment. - Stroke (hemorrhagic or ischemic) or transient ischemic attack within 12 weeks before enrollment. - Major surgery within 3 months prior to screening (excluding vascular access surgery). - Clinical evidence of systemic infection or inflammatory disease at the time of screening and up until enrollment.

For peritoneal dialysis subjects, an episode of peritonitis within 30 days before screening. - Known positivity for HIV antibody or Hepatitis B surface antigen.

Clinical evidence of current malignancy with the exception of basal cell or squamous cell carcinoma of the skin. - Blood transfusions within 8 weeks prior to screening or active bleeding. - Androgen therapy within 8 weeks prior to screening.

Systemic hematological disease (eg ,sickle cell anemia, myelodysplastic syndromes, hematological malignancy); myeloma; hemolytic anemia. - Other investigational products are excluded. - Subject is currently enrolled in, or has not yet completed, a period of at least 30 days since ending other investigational device or drug trial(s).

Psychiatric, addictive, or any other disorder that compromises ability to give truly informed consent for participation in this study. - Pregnant or breast feeding (women of child-bearing potential must be taking adequate contraceptive precautions). - Anticipating or scheduled for a living-related kidney transplant. - Known history of severe hyperparathyroidism (PTH >1500pg/ml) within 3 months prior top enrollment. - Currently receiving home hemodialysis treatment. - Currently receiving immunosuppressive therapy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00156949

Sponsors and Collaborators
Study Director: MD Amgen

Additional Information:
Responsible Party: Global Development Leader, Amgen Inc. Identifier: NCT00156949     History of Changes
Other Study ID Numbers: 20040268
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: February 19, 2010
Last Verified: February 2010

Keywords provided by Amgen:
Chronic Kidney Disease
Anemia Treatment for Dialysis Patients

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Epoetin Alfa