A Phase 3b Study of Erythropoietin Drugs Using a Specified Dosing Algorithm in Patients With Chronic Kidney Disease on Hemodialysis

NCT02504294 | Completed Phase 3 Results

• 2 other identifiers: ZIN-EPO-1503C3461008
• Study Type: interventional
• Target: 432
• Locations: 2 countries
• Sites: 45

Brief Summary

A phase 3b study for subjects receiving Epogen to compare a dosing algorithm between Hospira Epoetin and Standard of Care Epogen.

Conditions

Chronic Kidney Disease (CKD)

Outcome Measures

Primary Outcomes (1)

• Percentage of Time When Participants Had Hemoglobin Levels Between 9 to 11 Gram Per Deciliter (g/dL)

  Week 17 up to Week 24

Secondary Outcomes (1)

• Change From Baseline in Weekly Mean Study Medication Dose Over Final 8 Weeks of Study Treatment

  Baseline (8 Weeks prior to randomization), Week 17 up to Week 24

Study Arms (2)

Epoetin Hospira

OTHER

Epoetin Hospira Arm

Biological: Epoetin Hospira Arm; Drug: IV Iron

Standard of Care

OTHER

Standard of care arm

Other: Standard of Care Arm; Drug: IV Iron

Interventions

Epoetin Hospira Arm BIOLOGICAL

Epoetin Hospira Arm: Epoetin Hospira will be administered intravenously (IV) per the analogous version of the Fresenius Medical Care North America (FMCNA) cMAB 1 (inclusive of version 1.0, 1.1,...)erythropoietin stimulating agents (ESA) dosing algorithm for Epoetin Hospira for 24 weeks. Subjects will have Epoetin Hospira initiated using the same ESA dose level and frequency of administration for Epogen prior to randomization into the trial. Subjects will also receive IV iron per the FMCNA protocol that is standard of care at FMCNA clinics.

Epoetin Hospira

Standard of Care Arm OTHER

Standard of care arm: No interventions will be performed in this arm for the clinical study; and subjects will receive ongoing standard of care, which includes Epogen administered IV per the FMCNA cMAB 5 (inclusive of versions 5.0, 5.1,....) ESA dosing algorithm and IV iron per the FMCNA protocol that is standard of care, at FMCNA clinics during the contemporaneous 24 week period.

Standard of Care

IV Iron DRUG

Subjects will also receive IV iron per the FMCNA protocol that is standard of care at FMCNA clinics.

Epoetin Hospira; Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects eligible to be entered into the study will meet all of the following criteria:
• Adult female or male subjects; age ≥ 18 years.
• End stage renal disease subjects treated in-center with the modality of hemodialysis for ≥ 120 days.
• Diagnosed with anemia.
• Administered routine Epogen therapy for at least 16 weeks by an IV route for treatment of anemia using an Epogen version of an FMCNA dosing algorithm for ESA, and did not miss more than 3 prescribed doses of Epogen within 12 weeks prior to randomization.
• Currently using the IV Epogen version of the ESA dosing algorithm cMAB 5 (inclusive of versions 5.0, 5.1, …) for anemia management.
• Receiving hemodialysis at a clinic using the FMCNA dosing algorithm for IV iron that is the FMCNA standard of care treatment for iron replacement.

You may not qualify if:

• Subjects that meet any of the following criteria will be ineligible to be entered into the interventional cohort:
• Subjects unable to provide a signed and dated informed consent for this clinical research study.
• As determined by the Investigator, female subjects of child bearing potential who do not agree to use a highly effective method of contraception.
• Any condition as determined by the investigator that would place a subject at an increased risk, or preclude subject's full compliance with the study procedures and visits.
• Female subjects who are known to be or found to be, pregnant or lactating.
• Subjects that are not a candidate for ESA therapies per the label warnings listed in the package insert for Epogen and/or contraindications to Epoetin Hospira listed in the Investigators' Brochure; or have had a known positive test for anti-rhEPO antibodies.
• Treatment with any investigational drug within 30 days prior to randomization and throughout this clinical trial.
• Diagnosed with any concurrent condition that could lead to greater-than-normal loss of blood, including but not limited to:
• Menorrhagia, peptic ulcer disease, gastrointestinal bleeding, blood dyscrasia, hemoglobinopathy
• Use of anticoagulation therapy, including warfarin with a target international normalized ratio (INR) of 2 or greater Anti-platelet therapy (e.g. aspirin or clopidogrel) is permitted, as is heparin given during hemodialysis. Low-dose warfarin is permitted and defined as the presence of at least two INR values less than or equal to 1.5 during the 120 days prior to enrollment and no values exceeding 1.5 at any time after 120 days prior to enrollment.
• Subjects started on warfarin with a known INR goal of 2.0 or greater are to receive no further treatment with the study drugs, but follow up visits can continue.
• Subjects on warfarin who meet criteria to enter the study are terminated if an INR \> 2.0 is discovered or if no INR is available for 60 days.
• History of transfusion of any blood product in the past 3 months, or 2 or more transfusions in the past 1 year; or donated or lost \> 475 mL blood volume (including plasmapheresis) in the past 3 months.
• Subjects currently receiving a long acting ESA, or who have received a long acting ESA in the 16 weeks prior to study randomization

Sponsors & Collaborators

• Pfizer: lead
• Hospira, now a wholly owned subsidiary of Pfizer: collaborator

Study Sites (45)

California Institute of Renal Research

Chula Vista, California, 91910, United States

Location

California Institute of Renal Research at Fresenius Medical Care

Poway, California, 92064, United States

Location

Fresenius Medical Care Rancho

Rancho Bernardo, California, 92127, United States

Location

California Institute of Renal Research at Fresenius Medical Care Kearny Mesa

San Diego, California, 92111, United States

Location

Fresenius Medical Care Paradise Valley

San Diego, California, 92139, United States

Location

Fresenius Medical Care

Tampa, Florida, 33609, United States

Location

Fresenius Medical Care

Tampa, Florida, 33610, United States

Location

Genesis Clinical Research, LLC

Tampa, Florida, 33614, United States

Location

Frenova Renal Research

Boise, Idaho, 83702, United States

Location

Fresenius Medical Care North America - Liberty Dialysis

Boise, Idaho, 83702, United States

Location

Frenova Renal Research

Caldwell, Idaho, 83605, United States

Location

Fresenius Medical Care North America - Liberty Dialysis

Caldwell, Idaho, 83605, United States

Location

Frenova Renal Research

Meridian, Idaho, 83642, United States

Location

Fresenius Medical Care North America - Liberty Dialysis

Meridian, Idaho, 83642, United States

Location

Frenova Renal Research

Nampa, Idaho, 83686, United States

Location

Fresenius Medical Care North America - Liberty Dialysis

Nampa, Idaho, 83686, United States

Location

Fresenius Medical Care-Kalamazoo East

Kalamazoo, Michigan, 49001, United States

Location

Paragon Health PC DBA Nephrology Center

Kalamazoo, Michigan, 49007, United States

Location

Fresenius Medical Care-Oshtemo

Kalamazoo, Michigan, 49009, United States

Location

Fresenius Medical Care, Biloxi Dialysis Unit

Biloxi, Mississippi, 39530, United States

Location

North Gulfport

Gulfport, Mississippi, 39501, United States

Location

South Mississippi Kidney Center

Gulfport, Mississippi, 39503, United States

Location

FMC Charlotte

Charlotte, North Carolina, 28204, United States

Location

Metrolina Nephrology Associates, PA

Charlotte, North Carolina, 28204, United States

Location

Briggs Avenue Dialysis Center

Durham, North Carolina, 27703, United States

Location

Durham Nephrology Associates

Durham, North Carolina, 27704, United States

Location

FMC Matthews

Matthews, North Carolina, 28105, United States

Location

Fresenius Medical Care- Lansdale Dialysis

Lansdale, Pennsylvania, 19446, United States

Location

Delaware Valley Nephrology and Hypertension Associates, PC

Philadelphia, Pennsylvania, 19118, United States

Location

Fresenius Medical Care

Warwick, Rhode Island, 02886, United States

Location

Fresenius Crossville Dialysis Unit

Crossville, Tennessee, 38555, United States

Location

Fresenius Medical Care-Franklin

Franklin, Tennessee, 37067, United States

Location

Knoxville Kidney Center, PLLC

Knoxville, Tennessee, 37923, United States

Location

Fresenius Dialysis West

Knoxville, Tennessee, 37934, United States

Location

Nephrology Associates, PC

Nashville, Tennessee, 37205, United States

Location

Fresenius Medical Care - Austin North 4478

Austin, Texas, 78758, United States

Location

Research Management Inc

Austin, Texas, 78758, United States

Location

Mission Bend Dialysis (FMC#3971)

Houston, Texas, 77083, United States

Location

Southwest Houston Research, Ltd.

Houston, Texas, 77099, United States

Location

Gamma Medical Research Inc

McAllen, Texas, 78503, United States

Location

Rosenberg Dialysis (FMC#1197)

Rosenberg, Texas, 77471, United States

Location

Fresenius Medical Care Weslaco

Weslaco, Texas, 78596, United States

Location

Fresenius Medical Care Carolina

Carolina, 00983, Puerto Rico

Location

Fresenius Medical Care

Humacao, 00791, Puerto Rico

Location

Fresenius Medical Care San Juan

San Juan, 00917, Puerto Rico

Location

Related Publications (2)

• 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.

  PMID: 36791280 DERIVED

• Thadhani R, Guilatco R, Hymes J, Maddux FW, Ahuja A. Switching from Epoetin Alfa (Epogen(R)) to Epoetin Alfa-Epbx (RetacritTM) Using a Specified Dosing Algorithm: A Randomized, Non-Inferiority Study in Adults on Hemodialysis. Am J Nephrol. 2018;48(3):214-224. doi: 10.1159/000492621. Epub 2018 Sep 7.

  PMID: 30196301 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

ferryl iron

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Pfizer, Inc.
• Organization: Pfizer ClinicalTrials.gov Call Center

ClinicalTrials.gov_Inquiries@Pfizer.com

1--800--718--1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2015
• First Posted: July 21, 2015
• Study Start: July 13, 2015
• Primary Completion: July 2, 2016
• Study Completion: July 16, 2016
• Last Updated: June 13, 2018
• Results First Posted: June 13, 2018

Record last verified: 2018-05

Locations

US (42); PR (3)