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

NCT ID: NCT01473407

Last Updated: 2018-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 612 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2014-02-11

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.

Conditions

Chronic Kidney Disease; Chronic Renal Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Epoetin Hospira

Epoetin Hospira

Group Type: EXPERIMENTAL

Epoetin Hospira

Intervention Type: BIOLOGICAL

Variable dose

Epogen (Amgen)

Epogen (Amgen)

Group Type: ACTIVE_COMPARATOR

Epogen (Amgen)

Intervention Type: BIOLOGICAL

Variable dose

Interventions

Epoetin Hospira

Variable dose

Intervention Type: BIOLOGICAL

Epogen (Amgen)

Variable dose

Intervention Type: BIOLOGICAL

Other Intervention Names

Epoetin Alfa

Eligibility 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) 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

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 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospira, now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role: collaborator

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Montgomery Kidney Specialists

Montgomery, Alabama, United States

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

South Florida Research Institute

Lauderdale Lakes, Florida, United States

San Marcus Research Clinic, Inc

Miami, Florida, United States

Nephrology Associates of South Miami

Miami, Florida, United States

ARA Naples South Dialysis Center

Naples, Florida, United States

ARA- Naples Dialysis Center, LLC

Naples, Florida, United States

Innovative Medical Research of South Florida, Inc.

North Miami Beah, Florida, United States

Discovery Medical Research Group, Inc.

Ocala, Florida, United States

Central Florida Kidney Centers

Orlando, Florida, United States

Renal Physicians of Georgia, PC

Dublin, Georgia, United States

Boise Kidney & Hypertension Institute, PLLC

Meridian, Idaho, United States

Research by Design, LLC

Evergreen Park, Illinois, United States

North Suburban Nephrology, LLC

Gurnee, Illinois, United States

Nephrology Specialists, PC

Merrillville, Indiana, United States

Westbank Nephrology Associates

Marrero, Louisiana, United States

Internal Medicine Specialists

New Orleans, Louisiana, United States

Northwest Louisiana Nephrology

Shreveport, Louisiana, United States

DaVita Dialysis Centers

Clinton Township, Michigan, United States

St. Clair Specialty Physicians, P.C.

Detroit, Michigan, United States

South Mississippi Medical Research, PLLC

Gulfport, Mississippi, United States

Chromalloy American Kidney Center

St Louis, Missouri, United States

Kidney Specialists of Southern Nevada

Las Vegas, Nevada, United States

Hypertension & Nephrology Associates

Eatontown, New Jersey, United States

Brookdale Physician Dialysis Associates

Brooklyn, New York, United States

Lower Manhattan Dialysis Center

New York, New York, United States

Mountain Kidney and Hypertension Associates, PA

Asheville, North Carolina, United States

East Carolina University, ECU School of Medicine, Department of Internal Medicine

Greenville, North Carolina, United States

Eastern Nephrology Associates, PLLC

New Bern, North Carolina, United States

Brookview Hills Research Associates, LLC

Winston-Salem, North Carolina, United States

Cincinnati VA Medical Center

Cincinnati, Ohio, United States

HNC Dialysis Ltd.

Columbus, Ohio, United States

Bayview Nephrology, Inc

Erie, Pennsylvania, United States

DaVita-Erie Dialysis Center

Erie, Pennsylvania, United States

UPMC Hamot Clinical Trials Department

Erie, Pennsylvania, United States

Franklin Dialysis Center

Philadelphia, Pennsylvania, United States

Delaware Valley Nephrology and Hypertension Associates, PC

Philadelphia, Pennsylvania, United States

Nephrology and Internal Medicine of Anderson

Anderson, South Carolina, United States

Columbia Nephrology Associates, P.A.

Columbia, South Carolina, United States

Columbia Nephrology Associates, PA

Columbia, South Carolina, United States

Palmetto Nephrology, PA

Orangeburg, South Carolina, United States

South Carolina Nephrology and Hypertension Center, Inc.

Orangeburg, South Carolina, United States

Desert Nephrology Medical Group

Sumter, South Carolina, United States

Southeast Renal Research Institute

Chattanooga, Tennessee, United States

South Arlington Dialysis Center

Arlington, Texas, United States

Texas Renal Care

Greenville, Texas, United States

Med Center Dialysis

Houston, Texas, United States

Meyerland Dialysis

Houston, Texas, United States

Millenium Clinical Research, Inc.

Houston, Texas, United States

Millennium Clinical Research, Inc.

Houston, Texas, United States

Research Across America

Houston, Texas, United States

Southwest Houston Dialysis

Houston, Texas, United States

Southwest Houston Research, Ltd.

Houston, Texas, United States

Texas Tech University Health Sciences Center

Lubbock, Texas, United States

Private practice of Roberto Mangoo-Karim MD

McAllen, Texas, United States

Missouri City Dialysis

Missouri City, Texas, United States

San Antonio Kidney Disease Center Physicians Group, P.L.L.C.

San Antonio, Texas, United States

DaVita Dialysis Center-Floyd Curl Dialysis

San Antonio, Texas, United States

Clinical Research and Consulting Center, LLC

Fairfax, Virginia, United States

Peninsula Kidney Associates

Hampton, Virginia, United States

Internal Medicine Kidney and Hypertension Center

Norfolk, Virginia, United States

Consolidated Medical Plaza

Caguas, , Puerto Rico

Countries

United States; Puerto Rico

References

Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3.

Reference Type: DERIVED

PMID: 36791280 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32734207 (View on PubMed)

Other Identifiers

C3461001

Identifier Type: OTHER

Identifier Source: secondary_id

EPOE-10-01

Identifier Type: -

Identifier Source: org_study_id