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

Completed · Phase 3

Conditions studied: Chronic Kidney Disease, Chronic Renal Failure

In brief

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.

Key facts

Study ID

NCT01473407

Run by

Pfizer

People needed

612

Starts

2012-01-31

Expected to finish

2014-02-11

Last updated by the study team

2018-09-10

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient is able to provide written informed consent after risks and benefits of the study have been explained prior to any study related activities
• 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
• 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
• Patients with adequate iron stores, defined as ferritin >100 μg/L and TSAT >20%, prior to randomization
• Male or female patients aged 18 to 80 years (both inclusive)
• 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

You may not qualify if…

• Maintenance Epoetin dosage >600 U/kg per week (1-3 times per week)
• Treatment with long-acting epoetin analogues such as Aranesp ® within 3 months prior to randomization
• 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)
• 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
• Known, clinically manifested deficiency of folic acid and/or vitamin B12 (irrespective of whether currently treated or not)
• 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
• Contraindication for the test drug or have been previously treated with Epoetin Hospira
• Relative or absolute iron deficiency prior to randomization
• Platelet count below 100 x 10\^9/L
• Clinically relevant increase of CRP (>10 mg/dL) for at least 2 weeks
• 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
• 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)

Where it is running

• Southwest Clinical Research Institute, LLC — Tempe, Arizona, United States
• Lakhi M. Sakhrani, MD A Medical Coporation — Alhambra, California, United States
• North America Research Institute — Azusa, California, United States
• DaVita Dialysis Center-Bakersfield Dialysis Center — Bakersfield, California, United States
• Ong, Rubin, Shahmir A Medical Corp DBA: Solano Kidney Care — Fairfield, California, United States
• A Medical Corporation — Glendale, California, United States
• Renal Consultants Medical Group — Granada Hills, California, United States
• La Puente Dialysis Center — La Puente, California, United States
• Advanced Medical Research, LLC — Lakewood, California, United States
• DaVita Bixby Knolls Dialysis — Long Beach, California, United States
• Bayview Nephrology, Inc — Long Beach, California, United States
• Academic Medical Research Institute — Los Angeles, California, United States
• Desert Nephrology Medical Group — Modesto, California, United States
• La Jolla Clinical Research, Inc. — National City, California, United States
• Valley Renal Medical Group — Northridge, California, United States
• Ontario Dialysis Inc — Ontario, California, United States
• Discovery medical Research Group, Inc. — Porterville, California, United States
• Nephrology Educational Services and Research, Inc — Tarzana, California, United States
• Queen Dialysis Center — West Covina, California, United States
• American Institute of Research — Whittier, California, United States
• Mark C. Lee, Inc. Santa Fe Springs Dialysis — Whittier, California, United States
• North Valley Nephrology — Yuba City, California, United States
• Nephrology and Hypertension Associates — Middlebury, Connecticut, United States
• South Florida Nephrology, Inc. — Coral Springs, Florida, United States
• Montgomery Kidney Specialists — Montgomery, Alabama, United States

Full record on ClinicalTrials.gov

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