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

Completed · Phase 3

Conditions studied: Chronic Renal Failure, Chronic Kidney Disease

In brief

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.

Key facts

Study ID

NCT01473420

Run by

Pfizer

People needed

320

Starts

2012-01-17

Expected to finish

2014-02-28

Last updated by the study team

2018-08-09

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) 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
• 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 plasma 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 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

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 12 weeks 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 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
• Contraindication for the test drug or have been previously treated with Epoetin Hospira
• Relative or absolute iron deficiency prior to randomization into the Maintenance Period
• 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

• National Institute of Clinical Research — Bakersfield, California, United States
• Long Beach Dialysis Center — Long Beach, California, United States
• Academic Medical Research Institute — Los Angeles, California, United States
• Long Beach Dialysis Center — Modesto, California, United States
• Innovative Dialysis Center of Northridge, LLC — Northridge, California, United States
• Valley Renal Medical Group — Northridge, California, United States
• Research Management Inc. — Paramount, California, United States
• Pleasanton Dialysis Center — Pleasanton, California, United States
• Sunset Dialysis Center — Rancho Cordova, California, United States
• Capital Nephrology Medical Group — Sacramento, California, United States
• Chabot Nephrology Medical Group — San Leandro, California, United States
• San Leandro Dialysis — San Leandro, California, United States
• Renal Consultants Medical Group — Santa Clarita, California, United States
• Intercommunity Dialysis Center — Whittier, California, United States
• American Institute of Research — Whittier, California, United States
• Whittier Kidney Dialysis Center — Whittier, California, United States
• Western Nephrology and Metabolic Bone Disease, PC — Arvada, Colorado, United States
• Kidney Center of Westminster, LLC — Westminster, Colorado, United States
• Western Nephrology and Metabolic Bone Disease, PC — Westminster, Colorado, United States
• Pines Clinical Research Inc. — Pembroke Pines, Florida, United States
• Dialysis Clinic, Inc. - Albany — Albany, Georgia, United States
• Kidney Care Associates — Augusta, Georgia, United States
• Renal Physicians of Georgia, PC — Dublin, Georgia, United States
• Neomedica Marquette Park — Chicago, Illinois, United States
• North America Research Institute — Azusa, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.