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A Phase 3 Study Comparing the Effects of Subcutaneous 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 - 13)

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ClinicalTrials.gov Identifier: NCT01473420
Recruitment Status : Completed
First Posted : November 17, 2011
Results First Posted : June 20, 2018
Last Update Posted : August 9, 2018
Sponsor:
Collaborator:
Hospira, now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE November 2, 2011
First Posted Date  ICMJE November 17, 2011
Results First Submitted Date  ICMJE May 16, 2018
Results First Posted Date  ICMJE June 20, 2018
Last Update Posted Date August 9, 2018
Actual Study Start Date  ICMJE January 17, 2012
Actual Primary Completion Date February 28, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 21, 2018)
  • Mean Weekly Hemoglobin Level From Week 30 to Week 34: Maintenance Period [ Time Frame: Week 30 up to Week 34 ]
  • Mean Weekly Dosage of Study Medication From Week 30 to Week 34: Maintenance Period [ Time Frame: Week 30 up to Week 34 ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 16, 2011)
Change between treatments in mean weekly Hb level [ Time Frame: Baseline and last 4 weeks of treatment ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 21, 2018)
  • Mean Weekly Hemoglobin Level From Week 19 to Week 34: Maintenance Period [ Time Frame: Week 19 up to Week 34 ]
  • Mean Weekly Dosage of Study Medication From Week 19 to Week 34: Maintenance Period [ Time Frame: Week 19 up to Week 34 ]
  • Total Dose of Study Medication Administered: Maintenance Period [ Time Frame: Week 19 up to Week 34 ]
    In this outcome measure mean of total dose of study medication administered in maintenance period was reported.
  • Percentage of Participants With Mean Weekly Hemoglobin Level Within the Target Range: Maintenance Period [ Time Frame: Week 26, 34 ]
    Percentage of participants who had hemoglobin level within the target range of 9 to 11 g/dL for the specified weeks were reported.
  • Percentage of Participants Who Required Permanent Dose Changes: Maintenance Period [ Time Frame: Week 19 up to Week 34 ]
  • Percentage of Participants Who Required Temporary Dose Changes: Maintenance Period [ Time Frame: Week 19 up to Week 34 ]
  • Percentage of Participants With Any Transient Change of Hemoglobin Level Greater Than (>) 1.0 Gram Per Deciliter (g/dL): Maintenance Period [ Time Frame: Week 19 up to Week 34 ]
  • Percentage of Participants With Mean Weekly Hemoglobin Level Outside the Target Range: Maintenance Period [ Time Frame: Week 26, 34 ]
    Percentage of participants who had hemoglobin level outside the target range of 9 to 11 g/dL for the specified weeks were reported.
  • Percentage of Participants Who Qualified as Optimally Titrated and Stable: Titration Period [ Time Frame: Week 1 up to Week 18 ]
  • Percentage of Participants Who Received Blood Transfusions: Maintenance Period [ Time Frame: Week 19 up to Week 34 ]
  • Number of Participants With Change in Mean Dose of Study Medication Based on Hemoglobin Level: Maintenance Period [ Time Frame: Week 19 up to Week 34 ]
    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
  • Percentage of Participants With Any Transient Change of Hemoglobin Level Greater Than (>) 2.0 Gram Per Deciliter (g/dL) in Hemoglobin Level: Maintenance Period [ Time Frame: Week 19 up to Week 34 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 16, 2011)
  • Change between mean weekly Hb level in 16 weeks of treatment in the Maintenance Period [ Time Frame: Baseline and week 16 of the Maintenance Period ]
  • Change between treatments in mean weekly dosage per kg body weight delivered in 16 weeks of treatment in the Maintenance Period [ Time Frame: Baseline and week 16 of the Maintenance Period ]
  • The proportion of patients with any transient change of Hb level >1 g/dL during the Maintenance Period [ Time Frame: Baseline and weeks 1- 16 of the Maintenance Period ]
Current Other Pre-specified Outcome Measures
 (submitted: July 12, 2018)
  • Percentage of Participants With Hemoglobin Level Less Than (<) 8.0 Gram Per Deciliter (g/dL): Maintenance Period [ Time Frame: Week 19 up to Week 34 ]
  • Percentage of Participants With Hemoglobin Level Greater Than (>) 12.0 Gram Per Deciliter (g/dL): Maintenance Period [ Time Frame: Week 19 up to Week 34 ]
  • Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Titration Period: Week 1 up to Week 18 and Maintenance Period: Week 19 up to Week 38 ]
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events.
  • Number of Participants With Treatment-Emergent Adverse Events by Severity [ Time Frame: Titration Period: Week 1 up to Week 18 and Maintenance Period: Week 19 up to Week 38 ]
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment 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).
  • Number of Participants With Treatment Related Adverse Events (AEs) [ Time Frame: Titration Period: Week 1 up to Week 18 and Maintenance Period: Week 19 up to Week 38 ]
    An AE was any untoward medical occurrence in a participant who received study drug.
  • Number of Participants That Discontinued Treatment Due to a Treatment Emergent Adverse Event [ Time Frame: Titration Period: Week 1 up to Week 18 and Maintenance Period: Week 19 up to Week 38 ]
    In this outcome measure number of participants discontinued from study drug (Epoetin Hospira, Epogen) due to any AE were reported.
  • Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters [ Time Frame: Titration Period: Baseline (Pre-dose on Week 1) up to Week 18 and Maintenance Period: Baseline (Pre-dose on Week 19) up to Week 38 ]
    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.
  • Number of Participants With Clinically Significant Change From Baseline in Vital Signs [ Time Frame: Titration Period: Baseline (Pre-dose on Week 1) up to Week 18 and Maintenance Period: Baseline (Pre-dose on Week 19) up to Week 38 ]
    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.
  • Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) [ Time Frame: Titration Period: Baseline (Pre-dose on Week 1) up to Week 18 and Maintenance Period: Baseline (Pre-dose on Week 19) up to Week 38 ]
    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.
  • Number of Participants With Clinically Significant Change From Baseline in Physical Examination [ Time Frame: Titration Period: Baseline (Pre-dose on Week 1) up to Week 18 and Maintenance Period: Baseline (Pre-dose on Week 19) up to Week 38 ]
    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.
  • Percentage of Participants With Anti-Recombinant Human Erythropoietin (Anti-rhEPO) Antibodies [ Time Frame: Titration Period: Week 1 up to Week 18 and Maintenance Period: Week 19 up to Week 38 ]
    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.
  • Percentage of Participants With General Tolerability [ Time Frame: Titration Period: Week 1 up to Week 18 and Maintenance Period: Week 19 up to Week 38 ]
    General tolerability was classified as: 1) excellent tolerability = no reaction, 2) good tolerability = minimal reaction, 3) mild intolerability = reaction above that normally observed with any kind of subcutaneous product, 4) moderate intolerability = marked reaction, but no need for discontinuation of treatment and 5) severe intolerability = treatment discontinued due to intolerability.
  • Percentage of Participants With Local Tolerability [ Time Frame: Titration Period: Week 1 up to Week 18 and Maintenance Period: Week 19 up to Week 38 ]
    Local tolerability was classified as: 1) excellent tolerability = no reaction at site of injection, 2) good tolerability = minimal reaction at site of injection normally observed with any kind of subcutaneous product, 3) mild intolerability = reaction at site of injection above that normally observed with any kind of subcutaneous product, 4) moderate intolerability = marked reaction, but no need for discontinuation of treatment and 5) severe intolerability = treatment discontinued due to intolerability.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 3 Study Comparing the Effects of Subcutaneous 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
Official Title  ICMJE A Therapeutic-equivalence Study Comparing The Efficacy And Safety Of Subcutaneous Epoetin Hospira And Epoetin Alfa (Amgen) In Patients With Chronic Renal Failure Requiring Hemodialysis And Receiving Epoetin Maintenance Treatment
Brief Summary The purpose of this study is to demonstrate therapeutic equivalence of subcutaneous (SC) Epoetin Hospira compared to SC Epogen (Amgen), based on maintenance of hemoglobin (Hb) levels and study drug dose requirements in patients treated for anemia associated with chronic renal failure and on hemodialysis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Renal Failure
  • Chronic Kidney Disease
Intervention  ICMJE
  • Biological: Epoetin Hospira
    Variable dose
  • Biological: Epogen Amgen
    Variable dose
    Other Name: Epoetin Alfa
Study Arms  ICMJE
  • Experimental: Epoetin Hospira
    Epoetin Hospira
    Intervention: Biological: Epoetin Hospira
  • Active Comparator: Epogen (Amgen)
    Epogen (Amgen)
    Intervention: Biological: Epogen Amgen
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 9, 2014)
320
Original Estimated Enrollment  ICMJE
 (submitted: November 16, 2011)
288
Actual Study Completion Date  ICMJE February 28, 2014
Actual Primary Completion Date February 28, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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) dose administered IV or SC, 1 to 3 times per week for whom the following apply:

    • A change in Epogen dosing of no more than 10% from the mean
    • Mean hemoglobin between 9.0 and 11.0 g/dL
    • No more than one hemoglobin result outside of range from 9.0-11.0 g/dL
    • No hemoglobin result more than ±1 g/dL from the mean hemoglobin level
  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 plasma 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 postmenopausal for at least one year prior to randomization, surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or practicing at least one 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 12 weeks 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 that in the Investigator's opinion may be significant to exclude participation in the study, including but not limited to demyelinating diseases such as multiple sclerosis, 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 into the Maintenance Period
  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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01473420
Other Study ID Numbers  ICMJE EPOE-10-13
C3461003 ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Hospira, now a wholly owned subsidiary of Pfizer
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date July 2018

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