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EPO Deep Tank in Dialysis Subjects
This study has been completed.
First Received: September 8, 2005   Last Updated: April 16, 2009   History of Changes
Sponsored by: Amgen
Information provided by: Amgen
ClinicalTrials.gov Identifier: NCT00156949
  Purpose

Subject incidence of adverse events


Condition Intervention Phase
Chronic Kidney Disease
Drug: Epoetin alfa DT
Phase III

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study
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

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Subject incidence of adverse events [ Time Frame: Entire Study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Epoetin alfa seroreactivity. Laboratory parameters. [ Time Frame: Entire Study ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 550
Study Start Date: April 2005
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Epoetin alfa DT: Experimental 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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00156949

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen Inc. ( Global Development Leader )
Study ID Numbers: 20040268
Study First Received: September 8, 2005
Last Updated: April 16, 2009
ClinicalTrials.gov Identifier: NCT00156949     History of Changes
Health Authority: United States: Food and Drug Administration

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

Study placed in the following topic categories:
Epoetin Alfa
Renal Insufficiency
Urologic Diseases
Hematinics
Renal Insufficiency, Chronic
Benzocaine
Anemia
Kidney Failure, Chronic
Kidney Diseases
Kidney Failure

Additional relevant MeSH terms:
Epoetin Alfa
Renal Insufficiency
Urologic Diseases
Hematinics
Renal Insufficiency, Chronic
Therapeutic Uses
Hematologic Agents
Kidney Failure, Chronic
Kidney Diseases
Pharmacologic Actions
Kidney Failure

ClinicalTrials.gov processed this record on September 11, 2009