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

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

Condition(s) targeted: Chronic Kidney Disease (CKD)

Intervention: Epoetin Hospira Arm (Drug); Standard of Care Arm (Other)

Phase: Phase 3

Status: Recruiting

Sponsored by: Hospira, Inc.

Official(s) and/or principal investigator(s):
Seema Kumbhat, MD, Study Director, Affiliation: Hospira, Inc.
Jeffrey L Hymes, MD, Principal Investigator, Affiliation: Fresenius Medical Services

Overall contact:
Brigid Flanagan, RN, CCRC, Phone: 781-699-2970, Email: Brigid.Flanagan@FrenovaRenalResearch.com

Summary

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

Clinical Details

Official title: THE PIEDA STUDY: A Phase 3b Investigation of Erythropoietin Drugs Using a Specified Dosing Algorithm: A Randomized Open Label Dosing Study in Adult Chronic Kidney Disease Subject on Hemodialysis

Study design: Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Primary outcome: For each group, the proportion of subjects who maintain a mean hemoglobin level between 9 to 11 g/dL, using analogous dosing algorithms (FMCNA cMAB corporate algorithm 5) for each erythropoietin stimulating agents (ESA)

Secondary outcome: For each group, the change from baseline in the mean ESA dose per patient per week, using analogous dosing algorithms (FMCNA cMAB corporate algorithm 5) for each ESA

Detailed description: Primary Objective: To evaluate switching from Epogen to Epoetin Hospira for maintenance of hemoglobin levels in anemic chronic kidney disease (CKD) subjects on hemodialysis using a specified algorithm for the dosing of erythropoietin stimulating agents (ESA). Secondary Objective: To evaluate switching from Epogen to Epoetin Hospira on the dosing of ESA in anemic CKD subjects on hemodialysis using a specified algorithm for the dosing of ESA. Exploratory Objectives: To generate hypotheses regarding maintenance of hemoglobin levels, dosing of ESA, intravenous (IV) iron dosing requirements, transferrin saturation (TSAT) levels and ferritin levels associated with the switch from Epogen to Epoetin Hospira in anemic CKD subjects on hemodialysis using specified algorithms for the dosing of ESA and for the dosing of IV iron, that are standard of care.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Adult female or male subjects; age ≥18 years. 2. End stage renal disease subjects treated in-center with the modality of hemodialysis for ≥120 days. 3. Diagnosed with anemia. 4. Administered routine Epogen therapy for at least 16 weeks by an IV route for treatment of anemia using the Epogen version of the Fresenius Medical Care North America (FMCNA) dosing algorithm for ESA. 5. Currently using the IV Epogen version of the ESA dosing algorithm cMAB 5 for anemia management. 6. Receiving hemodialysis at a clinic using the FMCNA dosing algorithm for IV iron that is the FMCNA standard of care for iron replacement. Exclusion Criteria: 1. Subjects unable to provide a signed and dated informed consent for this clinical research study. 2. As determined by the Investigator, female subjects of childbearing potential who do not agree to use a highly effective method of contraception. 3. 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. 4. Female subjects who are known to be or found to be, pregnant or lactating. 5. 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. 6. Treatment with any investigational drug within 30 days prior to randomization and throughout this clinical trial. 7. 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, anticoagulation therapy (except when administered for the purpose of dialysis therapy and except aspirin (acetylsalicylic acid [ASA] therapies)) etc. 8. 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. 9. Subjects currently receiving a long acting ESA, or who have received a long acting ESA in the 16 weeks prior to study randomization.

Locations and Contacts

Brigid Flanagan, RN, CCRC, Phone: 781-699-2970, Email: Brigid.Flanagan@FrenovaRenalResearch.com

Carolina Dialysis, Carolina 00983, Puerto Rico; Not yet recruiting
Jose Cangiano, Phone: 787-763-7423, Email: jlcangiano@yahoo.com

Humacao Dialysis Facility, Humacao 00791, Puerto Rico; Not yet recruiting
Eugenia Galindo-Ramos, Phone: 787-914-7062, Email: eugeniagalindo@hotmail.com

Rio Piedras Dialysis, San Juan 00926, Puerto Rico; Not yet recruiting
Jose Cangiano, Phone: 787-763-7423, Email: jlcangiano@yahoo.com

San Juan Dialysis, San Juan 00917, Puerto Rico; Not yet recruiting
Jose Cangiano, Phone: 787-763-7423, Email: jlcangiano@yahoo.com

FMC Rancho, Rancho Bernardo, California 92127, United States; Recruiting
Mark Boiskin, Phone: 858-810-8180, Email: mboiskin@bnmg.org

Paradise Dialysis, San Diego, California 92139, United States; Recruiting
Jill Meyer, Phone: 619-422-2687, Ext: #5, Email: jmeyer@bnmg.org

Tampa Dialysis, Tampa, Florida 33609, United States; Not yet recruiting
Jesus Navarro, Phone: 813-873-1016, Ext: #1, #5, #2, Email: genclin@aol.com

Ybor City, Tampa, Florida 33610, United States; Not yet recruiting
Jesus Navarro, Phone: 813-873-1016, Ext: #1, #5, #2, Email: genclin@aol.com

Boise Dialysis, Boise, Idaho 83702, United States; Not yet recruiting
Arnold Silva, Phone: 208-472-0532, Email: asilva@boisekidney.com

Caldwell Dialysis, Caldwell, Idaho 83605, United States; Not yet recruiting
Arnold Silva, Phone: 208-472-0532, Email: asilva@boisekidney.com

Merridian Dialysis, Meridian, Idaho 83642, United States; Recruiting
Arnold Silva, Phone: 208-472-0532, Email: asilva@boisekidney.com

Nampa Dialysis, Nampa, Idaho 83686, United States; Not yet recruiting
Arnold Silva, Phone: 208-472-0532, Email: asilva@boisekidney.com

Kalamazoo East, Kalamazoo, Michigan 49002, United States; Not yet recruiting
Ahmed Aqeel, Phone: 269-384-6180, Ext: 218, Email: ahaqeel@gmail.com

Oshtemo Dialysis, Kalamazoo, Michigan 49009, United States; Recruiting
Ahmed Aqeel, Phone: 269-384-6180, Ext: 218, Email: ahaqeel@gmail.com

SMKC Biloxi, Biloxi, Mississippi 39530, United States; Not yet recruiting
Douglas Lanier, Phone: 228-863-7393, Email: douglasclanierjr@gmail.com

North Gulfport, Gulfport, Mississippi 39501 -6902, United States; Recruiting
Erica Hopkins, Phone: 228-265-3773, Email: Hopkins.erica@gmail.com

Orange Grove Dialysis, Gulfport, Mississippi 39503, United States; Not yet recruiting
Erica Hopskins, Phone: 228-265-3773, Email: Hopkins.erica@gmail.com

Charlotte Dialysis, Charlotte, North Carolina 28204, United States; Not yet recruiting
Peale Chuang, Phone: 704-731-6830, Email: pchuang@metrolinanephrology.com

Briggs Ave Dialysis, Durham, North Carolina 27703, United States; Not yet recruiting
Amarnath Kathresal, Phone: 919-477-3005, Email: akathresal@durneph.com

Matthews Dialysis, Matthews, North Carolina 28105, United States; Not yet recruiting
Peale Chuang, Phone: 704-731-6830, Email: pchung@metrolinanephrology.com

Wake Nephrology Associates P.A, Raleigh, North Carolina 27609, United States; Not yet recruiting
Mark Rothman, Phone: 919-876-7807, Ext: 226, Email: mrothman@wakenephrology.com

LANSDALE Dialysis, Lansdale, Pennsylvania 19446, United States; Recruiting
Edward Jones, Phone: 267-437-3163

Warwick Dialysis, Warwick, Rhode Island 02886, United States; Not yet recruiting
Douglas Shemin, Phone: 401-444-5212, Email: dshemin@lifespan.org

Crossville Dialysis, Crossville, Tennessee 38555, United States; Not yet recruiting
George Newman, Phone: 865-692-3462, Ext: 7, Email: enewmanmd@aol.com

Franklin Dialysis, Franklin, Tennessee 37067, United States; Not yet recruiting
James Wilbeck, Phone: 615-354-2463, Email: cwilbeck@tnkidney.com

Dialysis Assoc. West/West Knoxville, Knoxville, Tennessee 37934, United States; Recruiting
George Newman, Phone: 865-692-3462, Ext: 7, Email: enewmanmd@aol.com

Mission Bend, Houston, Texas 77083, United States; Recruiting
Marializa Bernardo, Phone: 281-598-2210, Ext: 106, Email: lizabernardo@swhresearch.com

Rosenberg Dialysis, Rosenburg, Texas 77471, United States; Not yet recruiting
Marializa Bernardo, Phone: 281-598-2210, Ext: 106, Email: lizabernardo@swhresearch.com

Weslaco Dialysis, Weslaco, Texas 78596, United States; Recruiting
Roberto Mangoo-Karim, Phone: 956-627-6094, Email: mangoo@gammamedicalresearch.com

Additional Information

Starting date: June 2015
Last updated: July 20, 2015

Page last updated: August 23, 2015

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