DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



A Phase 3 Study Comparing the Effects of Subcutaneous Epoetin Hospira and Epoetin Alfa (Amgen) in Patients With Chronic Renal Failure Requiring Hemodialysis and Receiving Epoetin Maintenance Treatment. AiME - Anemia Management With Epoetin

Information source: Hospira, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Renal Failure; Chronic Kidney Disease

Intervention: Epoetin Hospira (Biological); Epogen Amgen (Biological)

Phase: Phase 3

Status: Completed

Sponsored by: Hospira, Inc.

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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Difference between treatments (Epoetin Hospira and Epogen [Amgen]) in mean weekly Hb level during the last 4 weeks of the double-blind Maintenance Period

Difference between treatments (Epoetin Hospira and Epogen [Amgen]) in mean weekly dosage per kg body weight during the last 4 weeks of the double-blind Maintenance Period

Secondary outcome:

Difference between treatments (Epoetin Hospira and Epogen [Amgen]) in mean weekly Hb level in 16 weeks of treatment in the Maintenance Period

Difference between treatments (Epoetin Hospira and Epogen[Amgen]) in mean weekly dosage per kg body weight delivered in 16 weeks of treatment in the Maintenance Period

The total dose delivered during the 16 weeks of treatment in the Maintenance Period

The proportion of patients with a weekly mean Hb level within the target range (9-11 g/dL) at Weeks 8 and I 6 of the Maintenance Period

The proportion of patients requiring permanent dose changes during the Maintenance Period

The proportion of patients requiring temporary dose changes during the Maintenance Period

The proportion of patients with any transient change of Hb level >1 g/dL during the Maintenance Period

The proportion of patients with any Hb measurement outside the target range during the Maintenance Period

The proportion of patients qualifying as optimally titrated and stable at the end of the Titration Period

Incidence of patients receiving blood transfusions for each treatment group in the Maintenance Period

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

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) 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)

Locations and Contacts

Azusa, California 91702, United States

Bakersfield, California 93309, United States

Granada Hills, California 91344, United States

Long Beach, California 90813, United States

Los Angeles, California 90022, United States

Modesto, California 95350, United States

Northridge, California 91324, United States

Paramount, California 90723, United States

Sacramento, California 95825, United States

San Leandro, California 94578, United States

Whittier, California 90603, United States

Arvada, Colorado 80002, United States

Westminister, Colorado 80031, United States

Jupiter, Florida 33458, United States

Pembroke Pines, Florida 33028, United States

Albany, Georgia 31701, United States

Augusta, Georgia 30909, United States

Dublin, Georgia 31021, United States

Evergreen Park, Illinois 60805, United States

Witchita, Kansas 67214, United States

Lafayette, Louisiana 70506, United States

Marrero, Louisiana 70072, United States

Shreveport, Louisiana 71101, United States

Kalamazoo, Michigan 49007, United States

Kansas City, Missouri 64111, United States

Kansas City, Missouri 64131, United States

Saint Louis, Missouri 63136, United States

New Hyde Park, New Jersey 11040, United States

North Brunswick, New Jersey 08902, United States

Voorhees, New Jersey 08043, United States

College Point, New York 11356, United States

Flushing, New York 11355, United States

New York, New York 10010, United States

Raleigh, North Carolina 27609, United States

Cincinnati, Ohio 45267-0585, United States

Toledo, Ohio 43606, United States

Meadville, Pennsylvania 16355, United States

Columbia, South Carolina 29203, United States

Orangeburg, South Carolina 29118, United States

Knoxville, Tennessee 37923, United States

Austin, Texas 78758, United States

Dallas, Texas 75216, United States

Grand Prairie, Texas 75051, United States

Houston, Texas 77054, United States

Houston, Texas 77099, United States

Lufkin, Texas 75904, United States

San Antonio, Texas 78224, United States

Mechanicsville, Virginia 23116, United States

Additional Information

Starting date: November 2011
Last updated: May 1, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017