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

This study has been terminated.
(Regulatory decision not to proceed)
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00156962
First received: September 8, 2005
Last updated: July 17, 2008
Last verified: July 2008

September 8, 2005
July 17, 2008
April 2005
March 2007   (final data collection date for primary outcome measure)
Subject incidence of adverse events [ Time Frame: Entire Study ] [ Designated as safety issue: Yes ]
Subject incidence of adverse events
Complete list of historical versions of study NCT00156962 on ClinicalTrials.gov Archive Site
  • Epoetin alfa antibodies [ Time Frame: Entire Study ] [ Designated as safety issue: Yes ]
  • Changes from baseline laboratory and vital signs [ Time Frame: Entire Study ] [ Designated as safety issue: Yes ]
Epoetin alfa antibodies. Changes from baseline laboratory and vital signs
Not Provided
Not Provided
 
Epoetin Alfa (EPO) in Subjects With Chronic Kidney Disease (CKD)
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

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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Kidney Disease
  • 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
  • Drug: Epoetin alfa RB
    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
  • Active Comparator: Epoetin alfa RB
    Intervention: Drug: Epoetin alfa RB
  • Experimental: Epoetin alfa DT
    Intervention: Drug: Epoetin alfa DT
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
850
March 2007
March 2007   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00156962
20040259, NOT APPLILCABLE
Not Provided
Global Development Leader, Amgen Inc.
Amgen
Not Provided
Study Director: MD Amgen
Amgen
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP