Clinical trial NCT00156949: EPO Deep Tank in Dialysis Subjects
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Kidney Disease
Keywords: Epogen
Procrit
Chronic Kidney Disease
Anemia Treatment for Dialysis Patients
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 580
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Subject incidence of adverse events

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 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: