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
  Purpose

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


Condition Intervention Phase
Chronic Kidney Disease
Drug: Epoetin alfa DT
Drug: Epoetin alfa RB
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

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 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 ]

Estimated Enrollment: 850
Study Start Date: April 2005
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Epoetin alfa RB 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
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

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.

  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 - 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00156962

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

Additional Information:
No publications provided

Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00156962     History of Changes
Other Study ID Numbers: 20040259, NOT APPLILCABLE
Study First Received: September 8, 2005
Last Updated: July 17, 2008
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on July 24, 2014