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Trial record 1 of 1 for:    EPOE-10-01
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A Phase 3 Study Comparing the Effects of Intravenous Epoetin Hospira and Epoetin Alfa [Epogen] (Amgen) in Patients With Chronic Renal Failure Requiring Hemodialysis and Receiving Epoetin Maintenance Treatment. AiME - Anemia Management With Epoetin (AiME - 01)

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ClinicalTrials.gov Identifier: NCT01473407
Recruitment Status : Completed
First Posted : November 17, 2011
Results First Posted : July 13, 2018
Last Update Posted : September 10, 2018
Sponsor:
Collaborator:
Hospira, now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Pfizer

Brief Summary:
The purpose of this study is to demonstrate therapeutic equivalence of IV Epoetin Hospira compared to IV Epogen (Amgen), based on maintenance of Hb levels and study drug dose requirements in patients treated for anemia associated with chronic renal failure and on hemodialysis.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Chronic Renal Failure Biological: Epoetin Hospira Biological: Epogen (Amgen) Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 612 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Therapeutic-equivalence Study Comparing The Efficacy And Safety Of Intravenous Epoetin Hospira And Epoetin Alfa (Amgen) In Patients With Chronic Renal Failure Requiring Hemodialysis And Receiving Epoetin Maintenance Treatment
Actual Study Start Date : January 31, 2012
Actual Primary Completion Date : February 11, 2014
Actual Study Completion Date : February 11, 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Epoetin Hospira
Epoetin Hospira
Biological: Epoetin Hospira
Variable dose

Active Comparator: Epogen (Amgen)
Epogen (Amgen)
Biological: Epogen (Amgen)
Variable dose
Other Name: Epoetin Alfa




Primary Outcome Measures :
  1. Mean Weekly Hemoglobin Level From Week 21 to Week 24 [ Time Frame: Week 21 up to Week 24 ]
  2. Mean Weekly Dosage of Study Medication From Week 21 to Week 24 [ Time Frame: Week 21 up to Week 24 ]

Secondary Outcome Measures :
  1. Mean Weekly Hemoglobin Level Through 24 Weeks [ Time Frame: Week 1 up to Week 24 ]
  2. Mean Weekly Dosage of Study Medication Through 24 Weeks [ Time Frame: Week 1 up to Week 24 ]
  3. Total Dose of Study Medication Administered [ Time Frame: Week 1 up to Week 24 ]
  4. Percentage of Participants With Mean Weekly Hemoglobin Level Within the Target Range [ Time Frame: Week 12, 24 ]
    Percentage of participants who had hemoglobin level within the target range of 9 to 11 g/dL for the specified weeks were reported.

  5. Percentage of Participants Who Required Permanent Dose Changes of Study Medication [ Time Frame: Week 1 up to Week 24 ]
  6. Percentage of Participants Who Required Temporary Dose Changes of Study Medication [ Time Frame: Week 1 up to Week 24 ]
  7. Percentage of Participants With Any Transient Change of Hemoglobin Level Greater Than (>) 1 Gram Per Deciliter (g/dL) [ Time Frame: Week 1 up to Week 24 ]
  8. Percentage of Participants With Mean Weekly Hemoglobin Level Outside the Target Range [ Time Frame: Week 12, 24 ]
    Percentage of participants who had hemoglobin level outside the target range of 9 to 11 g/dL for the specified weeks were reported.

  9. Percentage of Participants Who Received Blood Transfusions [ Time Frame: Week 1 up to Week 24 ]
  10. Number of Participants With Change in Mean Dose of Study Medication Based on Hemoglobin Level [ Time Frame: Week 1 up to Week 24 ]
    In this outcome measure number of participants with change (increase and decrease) in mean dose of Epoetin Hospira and Epogen were categorized and reported according to their mean hemoglobin levels. Hemoglobin levels were divided in following classes: >11.0 g/dL, from 9.0 to 11.0 g/dL and <9.0 g/dL

  11. Percentage of Participants With Any Transient Change of Hemoglobin Greater Than (>) 2.0 Gram Per Deciliter (g/dL) in Hemoglobin Level [ Time Frame: Week 1 up to Week 24 ]

Other Outcome Measures:
  1. Percentage of Participants With Hemoglobin Level Less Than (<) 8.0 Gram Per Deciliter (g/dL) [ Time Frame: Week 1 up to Week 24 ]
  2. Percentage of Participants With Hemoglobin Level Greater Than (>) 12.0 Gram Per Deciliter (g/dL) [ Time Frame: Week 1 up to Week 24 ]
  3. Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Week 1 up to Week 28 ]
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; Initial or prolonged in-patient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events from first dose of study drug to the end of study (up to Week 28) that were absent before treatment or that worsened relative to pre-treatment state. AEs included both serious and non-serious adverse events.

  4. Number of Participants With Treatment-Emergent Adverse Events by Severity [ Time Frame: Week 1 up to Week 28 ]
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent were events between first dose of study drug to the end of study (up to Week 28) that were absent before treatment or that worsened relative to pre-treatment state. An AE was assessed according to severity; mild (AE was transient and easily tolerated by the participant), moderate (caused problem that did not interfere significantly with usual activities) and severe (caused problem that interferes significantly with usual activities and might be incapacitating or life-threatening).

  5. Number of Participants With Treatment Related Adverse Events (AEs) [ Time Frame: Week 1 up to Week 28 ]
    An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug.

  6. Number of Participants That Discontinued Treatment Due to a Treatment Emergent Adverse Event [ Time Frame: Week 1 up to Week 28 ]
    In this outcome measure number of participants who discontinued from study drug (Epoetin Hospira, Epogen) due to any AE were reported.

  7. Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters [ Time Frame: Baseline up to Week 28 ]
    Laboratory parameters: Hematology (hematocrit, hemoglobin, red blood cell count, reticulocytes, white blood cell count, neutrophils, bands, lymphocytes, monocytes, basophils, eosinophils, platelet count, mean corpuscular volume); coagulation panel (prothrombin time, international normalized ratio, activated partial thromboplastin time); clinical chemistry (blood urea nitrogen, creatinine, alanine aminotransferase, aspartate aminotransferase, total bilirubin, gamma-glutamyl transpeptidase, alkaline phosphatase, sodium, potassium, calcium, magnesium, phosphorus, uric acid, total protein, glucose, albumin, C-reactive protein, plasma ferritin, transferrin saturation). Participants with clinically significant change from baseline in laboratory parameters were as determined by the investigator.

  8. Number of Participants With Clinically Significant Change From Baseline in Vital Signs [ Time Frame: Baseline up to Week 28 ]
    Vital sign parameters: temperature (oral, tympanic, or other), blood pressure (diastolic and systolic), heart rate (in a seated position) and dry weight (post-dialysis). Participants with clinically significant change from baseline in vital signs were as determined by the investigator.

  9. Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) [ Time Frame: Baseline up to Week 28 ]
    ECG parameters: PR interval, QRS complex, QT interval and QTC interval. Participants with clinically significant change from baseline in ECG were as determined by the investigator.

  10. Number of Participants With Clinically Significant Change From Baseline in Physical Examination [ Time Frame: Baseline up to Week 28 ]
    Physical examination included examination of the following: skin, eyes, ears, throat, cardiac, respiratory, gastrointestinal, genitourinary and musculoskeletal systems. Participants with clinically significant change from baseline in physical examination were as determined by the investigator.

  11. Percentage of Participants With Anti-Recombinant Human Erythropoietin (Anti-rhEPO) Antibodies [ Time Frame: Week 1 up to Week 28 ]
    Percentage of participants with presence of anti-rhEPO antibodies were reported in this outcome measure. Radioimmunoprecipitation assay method was used to determine the presence of anti-rhEPO antibodies.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient is able to provide written informed consent after risks and benefits of the study have been explained prior to any study related activities
  2. Hemodialysis patients with chronic renal failure and renal anemia currently on stable Epogen (Amgen) treatment for at least 4 weeks prior to randomization, for whom the following apply (during this period):

    • Epogen (Amgen) dose has been administered intravenously 1 to 3 times per week with no more than a 10% dose change from the mean for at least 4 weeks prior to randomization
    • Stable hemoglobin, defined as meeting all of the following:

      • Mean hemoglobin during the 4 weeks prior to randomization between 9.0 and 11.0 g/dL
      • No more than one hemoglobin outside of range from 9.0-11.0 g/dL during the 4 weeks prior to randomization
      • No hemoglobin result more than ±1 g/dL from the mean hemoglobin level during the 4 week period prior to randomization
  3. Patients on stable, adequate dialysis for at least 12 weeks prior to randomization, defined as no clinically relevant changes of dialysis regimen and/or dialyzer
  4. Patients with adequate iron stores, defined as ferritin >100 μg/L and TSAT >20%, prior to randomization
  5. Male or female patients aged 18 to 80 years (both inclusive)
  6. If female, patient must be either postmenopausal for at least 1 year prior to randomization, surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), or practicing at least 1 of the following methods of birth control:

    • hormonal contraceptives (oral, parenteral, or transdermal) for at least 3 months prior to randomization
    • intrauterine device (IUD)
    • double-barrier method (condoms, contraceptive sponge, diaphragm, or vaginal ring with spermicidal jellies or cream)

If hormonal contraceptives are used, the specific contraceptive must have been used for at least 3 months prior to randomization. If the patient is currently using a hormonal contraceptive, she should also use a barrier method during this study and for at least 30 days following the administration of the patient's last dose

Exclusion Criteria:

  1. Maintenance Epoetin dosage >600 U/kg per week (1-3 times per week)
  2. Treatment with long-acting epoetin analogues such as Aranesp ® within 3 months prior to randomization
  3. Any of the following within 3 months prior to randomization:

    • Myocardial infarction
    • Stroke (cerebrovascular accident)/cerebrovascular insult (minor stroke) or transient ischemic attack/intracerebral bleeding/cerebral infarction
    • Severe/unstable angina
    • Coronary angioplasty, bypass surgery, or peripheral artery bypass graft
    • Decompensated congestive heart failure (New York Heart Association [NYHA] class IV)
    • Pulmonary embolism
    • Deep vein thrombosis or other thromboembolic event
    • Received live or attenuated vaccination (except flu vaccination)
  4. Uncontrolled Hypertension within the 4 weeks prior to randomization, defined as more than 10% of post-dialysis blood pressures >170 mmHg systolic and/or >110 mmHg diastolic, based on blood pressure readings obtained when the patient's post-dialysis body weight was not more than 0.5 kg above their listed dry weight
  5. Known, clinically manifested deficiency of folic acid and/or vitamin B12 (irrespective of whether currently treated or not)
  6. A patient with any active, uncontrolled systemic, inflammatory or malignant disease (including demyelinating diseases such as multiple sclerosis) that in the Investigator's opinion may be significant to exclude participation in the study, including but not limited to microbial, viral, or fungal infection or mental disease
  7. Contraindication for the test drug or have been previously treated with Epoetin Hospira
  8. Relative or absolute iron deficiency prior to randomization
  9. Platelet count below 100 x 10^9/L
  10. Clinically relevant increase of CRP (>10 mg/dL) for at least 2 weeks
  11. Significant drug sensitivity or a significant allergic reaction to any drug, as well as known hypersensitivity or idiosyncratic reaction to epoetin (or its excipients, including albumin) or any other related drugs that in the judgment of the Investigator is exclusionary for the study participation
  12. History of any of the following:

    • Detectable anti- rhEPO antibodies
    • Clinically relevant malnutrition
    • Confirmed aluminum intoxication
    • Myelodysplastic syndrome
    • Known bone marrow fibrosis (osteitis fibrosa cystica)
    • Known seizure disorder
    • Liver cirrhosis with clinical evidence of complications (portal hypertension, splenomegaly, ascites)
  13. A female patient who is pregnant, lactating or planning a pregnancy during the study
  14. History of drug abuse or alcohol abuse within 2 years prior to randomization as determined by the Investigator
  15. Current participation or participation in a drug or other investigational research study within 30 days prior to randomization
  16. May not be able to comply with the requirements of this clinical study, communicate effectively with study personnel, or is considered by the Investigator, for any reason, to be an unsuitable candidate for the study
  17. Donated or lost >475 mL (i.e., 1 pint) blood volume (including plasmapheresis) or had a transfusion of any blood product within 3 months prior to randomization
  18. A patient who in the Investigator's opinion, has any clinically significant abnormal laboratory evaluations, including liver function taken at Screening Visit
  19. Positive laboratory test for human immunodeficiency virus (HIV) or hepatitis B surface antigen (HBsAg)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01473407


  Show 85 Study Locations
Sponsors and Collaborators
Pfizer
Hospira, now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01473407     History of Changes
Other Study ID Numbers: EPOE-10-01
C3461001 ( Other Identifier: Alias Study Number )
First Posted: November 17, 2011    Key Record Dates
Results First Posted: July 13, 2018
Last Update Posted: September 10, 2018
Last Verified: August 2018

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Failure, Chronic
Urologic Diseases
Epoetin Alfa
Hematinics