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Epoetin Alfa (EPO) in Subjects With Chronic Kidney Disease (CKD)

Information source: Amgen
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Kidney Disease

Intervention: Epoetin alfa DT (Drug); Epoetin alfa RB (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Amgen

Official(s) and/or principal investigator(s):
MD, Study Director, Affiliation: Amgen


The purpose of this study is to look at subject incidence of adverse events.

Clinical Details

Official title: A Randomized, Open-Label Study to Assess the Safety of Epoetin Alfa Manufactured by Deep Tank Technology and Epoetin Alfa Manufactured by Roller Bottle Technology in Subjects With Chronic Kidney Disease Not on Dialysis

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Subject incidence of adverse events

Secondary outcome:

Epoetin alfa antibodies

Changes from baseline laboratory and vital signs

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 a comparable safety profile when administered to patients with CKD not on dialysis.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria: - ≥ 18 years of age - CKD not on dialysis: estimated glomerular

filtration rate (GFR) of 15mL/min to 60 mL/min (Modification of Diet in Renal Disease

[MDRD] equation) - Clinically stable - Mean of all screening/baseline hemoglobin (Hb)

values between 11. 0 to 13. 0 g/dL - Currently receiving Epoetin alfa RB (ie. Epogen or

Procrit) at the same dosing frequency for at least four weeks prior to randomization with

no more than 1 missed or withheld dose in each of the 2 week periods - Adequate iron

stores (transferrin saturation > 15. 0%) - No prior use of erythropoietic agents other than

Epogen, Procrit or Aranesp Exclusion Criteria: - Currently receiving treatment with any

erythropoietic stimulating protein other than Epogen or Procrit. - Prior use of

erythropoietic agents other than Epogen, Procrit or Aranesp. - Uncontrolled hypertension

(defined as diastolic blood pressure [BP] > 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 randomization. - Stroke (hemorrhagic or ischemic) or transient

ischemic attack within 12 weeks before randomization. - 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 randomization. -

Known history of severe hyperparathyroidism (intact parathyroid hormone [iPTH] >1500 pg/ml or bio-intact parathyroid hormone [biPTH] > 800 pg/ml within 3 months prior to

randomization). - 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. - Interferon therapy.

Patients known to have tested positive at any time in the past for antibodies to

erythropoietic proteins. - 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. - Currently receiving

home hemodialysis treatment. - Currently receiving immunosuppressive therapy.

Locations and Contacts

Additional Information

Notice regarding posted summaries of trial results

To access clinical trial results information click on this link

FDA-approved Drug Labeling

AmgenTrials clinical trials website

Starting date: April 2005
Last updated: July 17, 2008

Page last updated: August 23, 2015

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