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

Chronic Kidney Disease (CKD) Clinical Trial

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 Subjects On Hemodialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02504294
• Other study ID #: ZIN-EPO-1503
• Secondary ID: C3461008
• Status: Completed
• Phase: Phase 3
• Start date: July 13, 2015
• Est. completion date: July 16, 2016

Study information

• Verified date: May 2018
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 432
• Est. completion date: July 16, 2016
• Est. primary completion date: July 2, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

Subjects eligible to be entered into the study will meet all of the following 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 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.

5. Currently using the IV Epogen version of the ESA dosing algorithm cMAB 5 (inclusive of versions 5.0, 5.1, …) for anemia management.

6. Receiving hemodialysis at a clinic using the FMCNA dosing algorithm for IV iron that is the FMCNA standard of care treatment for iron replacement.

Exclusion Criteria

Subjects that meet any of the following criteria will be ineligible to be entered into the interventional cohort:

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 child bearing 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

• 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.

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

Related Conditions & MeSH terms

• Chronic Kidney Disease (CKD)
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Biological:
• Epoetin Hospira Arm
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.

Other:
• Standard of Care Arm
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.

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

Locations

Country	Name	City	State
Puerto Rico	Fresenius Medical Care Carolina	Carolina
Puerto Rico	Fresenius Medical Care	Humacao
Puerto Rico	Fresenius Medical Care San Juan	San Juan
United States	Fresenius Medical Care - Austin North 4478	Austin	Texas
United States	Research Management Inc	Austin	Texas
United States	Fresenius Medical Care, Biloxi Dialysis Unit	Biloxi	Mississippi
United States	Frenova Renal Research	Boise	Idaho
United States	Fresenius Medical Care North America - Liberty Dialysis	Boise	Idaho
United States	Frenova Renal Research	Caldwell	Idaho
United States	Fresenius Medical Care North America - Liberty Dialysis	Caldwell	Idaho
United States	FMC Charlotte	Charlotte	North Carolina
United States	Metrolina Nephrology Associates, PA	Charlotte	North Carolina
United States	California Institute of Renal Research	Chula Vista	California
United States	Fresenius Crossville Dialysis Unit	Crossville	Tennessee
United States	Briggs Avenue Dialysis Center	Durham	North Carolina
United States	Durham Nephrology Associates	Durham	North Carolina
United States	Fresenius Medical Care-Franklin	Franklin	Tennessee
United States	North Gulfport	Gulfport	Mississippi
United States	South Mississippi Kidney Center	Gulfport	Mississippi
United States	Mission Bend Dialysis (FMC#3971)	Houston	Texas
United States	Southwest Houston Research, Ltd.	Houston	Texas
United States	Fresenius Medical Care-Kalamazoo East	Kalamazoo	Michigan
United States	Fresenius Medical Care-Oshtemo	Kalamazoo	Michigan
United States	Paragon Health PC DBA Nephrology Center	Kalamazoo	Michigan
United States	Fresenius Dialysis West	Knoxville	Tennessee
United States	Knoxville Kidney Center, PLLC	Knoxville	Tennessee
United States	Fresenius Medical Care- Lansdale Dialysis	Lansdale	Pennsylvania
United States	FMC Matthews	Matthews	North Carolina
United States	Gamma Medical Research Inc	McAllen	Texas
United States	Frenova Renal Research	Meridian	Idaho
United States	Fresenius Medical Care North America - Liberty Dialysis	Meridian	Idaho
United States	Frenova Renal Research	Nampa	Idaho
United States	Fresenius Medical Care North America - Liberty Dialysis	Nampa	Idaho
United States	Nephrology Associates, PC	Nashville	Tennessee
United States	Delaware Valley Nephrology and Hypertension Associates, PC	Philadelphia	Pennsylvania
United States	California Institute of Renal Research at Fresenius Medical Care	Poway	California
United States	Fresenius Medical Care Rancho	Rancho Bernardo	California
United States	Rosenberg Dialysis (FMC#1197)	Rosenberg	Texas
United States	California Institute of Renal Research at Fresenius Medical Care Kearny Mesa	San Diego	California
United States	Fresenius Medical Care Paradise Valley	San Diego	California
United States	Fresenius Medical Care	Tampa	Florida
United States	Fresenius Medical Care	Tampa	Florida
United States	Genesis Clinical Research, LLC	Tampa	Florida
United States	Fresenius Medical Care	Warwick	Rhode Island
United States	Fresenius Medical Care Weslaco	Weslaco	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Pfizer	Hospira, now a wholly owned subsidiary of Pfizer

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Time When Participants Had Hemoglobin Levels Between 9 to 11 Gram Per Deciliter (g/dL)		Week 17 up to Week 24
Secondary	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