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
NCT01473407
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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
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)
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Descriptive Information | ||||
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Brief Title ICMJE | 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 | |||
Official Title ICMJE | 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 | |||
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. | |||
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 |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Wish JB, Rocha MG, Martin NE, Reyes CRD, Fishbane S, Smith MT, Nassar G. Long-term Safety of Epoetin Alfa-epbx for the Treatment of Anemia in ESKD: Pooled Analyses of Randomized and Open-label Studies. Kidney Med. 2019 Aug 28;1(5):271-280. doi: 10.1016/j.xkme.2019.06.009. eCollection 2019 Sep-Oct. | |||
* 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 | 612 | |||
Original Estimated Enrollment ICMJE | 674 | |||
Actual Study Completion Date ICMJE | February 11, 2014 | |||
Actual Primary Completion Date | February 11, 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
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:
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Sex/Gender ICMJE |
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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 | Puerto Rico, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01473407 | |||
Other Study ID Numbers ICMJE | EPOE-10-01 C3461001 ( 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 |
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PRS Account | Pfizer | |||
Verification Date | August 2018 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |