HX575 Epoetin Alfa Subcutaneously (s.c.) in Chronic Kidney Disease (CKD) (SENSE)
Primary Purpose
Chronic Kidney Disease
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
HX575 epoetin alfa (Sandoz)
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Disease focused on measuring Epoetin alfa, ESA, HX575, CKD
Eligibility Criteria
Main Inclusion Criteria:
- Adult male and female patients w or w/o dialysis treatment
- Stable i.v. or s.c. maintenance therapy with an EU-approved ESA treatment or ESA naïve.
- Adequate iron substitution
Main Exclusion Criteria:
- History of Pure Red Cell Aplasia (PRCA) or anti-erythropoietin (EPO) antibodies
- Contraindications for ESA therapy
- Serum albumin < 3.0 g/dL
- Immunocompromized patients (immunosuppressive treatment, chemotherapy)
- Hepatitis C infection on an active treatment or hepatitis B or human immunodeficiency virus (HIV) infection
- Systemic lupus erythematosus
- Symptomatic congestive heart failure, Unstable angina pectoris, or myocardial infarction within 6 months
- History of malignancy of any organ system within the last 5 years
- History of use of any non-EU approved ESA
Sites / Locations
- Sandoz Investigative Site
- Sandoz Investigative Site
- Sandoz Investigative Site
- Sandoz Investigative Site
- Sandoz Investigative Site
- Sandoz Investigative Site
- Sandoz Investigative Site
- Sandoz Investigative Site
- Sandoz Investigative Site
- Sandoz Investigative Site
- Sandoz Investigative Site
- Sandoz Investigative Site
- Sandoz Investigative Site
- Sandoz Investigative Site
- Sandoz Investigative Site
- Sandoz Investigative Site
- Sandoz Investigative Site
- Sandoz Investigative Site
- Sandoz Investigative Site
- Sandoz Investigative Site
- Sandoz Investigative Site
- Sandoz Investigative Site
- Sandoz Investigative Site
- Sandoz Investigative Site
- Sandoz Investigative Site
- Sandoz Investigative Site
- Sandoz Investigative Site
- Sandoz Investigative Site
- Sandoz Investigative Site
- Sandoz Investigative Site
- Sandoz Investigative Site
- Sandoz Investigative Site
- Sandoz Investigative Site
- Sandoz Investigative Site
- Sandoz Investigative Site
- Sandoz Investigative Site
- Sandoz Investigative Site
- Sandoz Investigative Site
- Sandoz Investigative Site
- Sandoz Investigative Site
- Sandoz Investigative Site
- Sandoz Investigative Site
- Sandoz Investigative Site
- Sandoz Investigative Site
- Sandoz Investigative Site
- Sandoz Investigative Site
- Sandoz Investigative Site
- Sandoz Investigative Site
- Sandoz Investigative Site
- Sandoz Investigative Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HX575 epoetin alfa (Sandoz)
Arm Description
Single arm
Outcomes
Primary Outcome Measures
Anti-Erythropoietin (EPO) Antibodies
The incidence of antibody formation against epoetin in Radio-immuno-precipitation (RIP) assay
Secondary Outcome Measures
Hemoglobin Level and Change From Baseline Period at Visit 16 (End of Study)
Actual values of hemoglobin levels at end of study visit and change from Baseline Period (Week -4 to Week -1)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01576341
Brief Title
HX575 Epoetin Alfa Subcutaneously (s.c.) in Chronic Kidney Disease (CKD)
Acronym
SENSE
Official Title
Open Label, Single Arm, Multicenter Study to Evaluate the Safety and Immunogenicity of HX575 Epoetin Alfa in the Treatment of Anemia Associated With Chronic Kidney Disease in Pre-dialysis and Dialysis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sandoz
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study will assess the immunogenicity, safety, and efficacy of HX575 epoetin alfa administered subcutaneously (s.c.) in patients suffering from anemia due to chronic kidney disease (CKD)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
Epoetin alfa, ESA, HX575, CKD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
417 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HX575 epoetin alfa (Sandoz)
Arm Type
Experimental
Arm Description
Single arm
Intervention Type
Drug
Intervention Name(s)
HX575 epoetin alfa (Sandoz)
Other Intervention Name(s)
Binocrit®, Epoetin alfa HEXAL®, Novicrit®, Abseamed®
Intervention Description
Eligible patients are scheduled to receive HX575 (INN: Epoetin alfa) as a solution for injection in order to achieve or maintain the correction of renal anemia.
Primary Outcome Measure Information:
Title
Anti-Erythropoietin (EPO) Antibodies
Description
The incidence of antibody formation against epoetin in Radio-immuno-precipitation (RIP) assay
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
Hemoglobin Level and Change From Baseline Period at Visit 16 (End of Study)
Description
Actual values of hemoglobin levels at end of study visit and change from Baseline Period (Week -4 to Week -1)
Time Frame
52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Main Inclusion Criteria:
Adult male and female patients w or w/o dialysis treatment
Stable i.v. or s.c. maintenance therapy with an EU-approved ESA treatment or ESA naïve.
Adequate iron substitution
Main Exclusion Criteria:
History of Pure Red Cell Aplasia (PRCA) or anti-erythropoietin (EPO) antibodies
Contraindications for ESA therapy
Serum albumin < 3.0 g/dL
Immunocompromized patients (immunosuppressive treatment, chemotherapy)
Hepatitis C infection on an active treatment or hepatitis B or human immunodeficiency virus (HIV) infection
Systemic lupus erythematosus
Symptomatic congestive heart failure, Unstable angina pectoris, or myocardial infarction within 6 months
History of malignancy of any organ system within the last 5 years
History of use of any non-EU approved ESA
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandoz Biopharmaceuticals
Organizational Affiliation
Sandoz
Official's Role
Study Chair
Facility Information:
Facility Name
Sandoz Investigative Site
City
Duesseldorf
Country
Germany
Facility Name
Sandoz Investigative Site
City
Homberg
Country
Germany
Facility Name
Sandoz Investigative Site
City
Nettetal
Country
Germany
Facility Name
Sandoz Investigative Site
City
Bari
Country
Italy
Facility Name
Sandoz Investigative Site
City
Czestochowa
Country
Poland
Facility Name
Sandoz Investigative Site
City
Gdansk
Country
Poland
Facility Name
Sandoz Investigative Site
City
Gdynia
Country
Poland
Facility Name
Sandoz Investigative Site
City
Olkusz
Country
Poland
Facility Name
Sandoz Investigative Site
City
Plock
Country
Poland
Facility Name
Sandoz Investigative Site
City
Poznan
Country
Poland
Facility Name
Sandoz Investigative Site
City
Wadowice
Country
Poland
Facility Name
Sandoz Investigative Site
City
Warzawa
Country
Poland
Facility Name
Sandoz Investigative Site
City
Bucuresti
Country
Romania
Facility Name
Sandoz Investigative Site
City
Constanta
Country
Romania
Facility Name
Sandoz Investigative Site
City
Lasi
Country
Romania
Facility Name
Sandoz Investigative Site
City
Oradea
Country
Romania
Facility Name
Sandoz Investigative Site
City
Timisoara
Country
Romania
Facility Name
Sandoz Investigative Site
City
Chelyabinsk
Country
Russian Federation
Facility Name
Sandoz Investigative Site
City
Kemerovo
Country
Russian Federation
Facility Name
Sandoz Investigative Site
City
Kolomna
Country
Russian Federation
Facility Name
Sandoz Investigative Site
City
Moscow
Country
Russian Federation
Facility Name
Sandoz Investigative Site
City
Mytischi
Country
Russian Federation
Facility Name
Sandoz Investigative Site
City
Nizhny Novgorod
Country
Russian Federation
Facility Name
Sandoz Investigative Site
City
Novosibirsk
Country
Russian Federation
Facility Name
Sandoz Investigative Site
City
Orenburg
Country
Russian Federation
Facility Name
Sandoz Investigative Site
City
Petrozavodsk
Country
Russian Federation
Facility Name
Sandoz Investigative Site
City
Podolsk
Country
Russian Federation
Facility Name
Sandoz Investigative Site
City
Pyatigorsk
Country
Russian Federation
Facility Name
Sandoz Investigative Site
City
Ryazan
Country
Russian Federation
Facility Name
Sandoz Investigative Site
City
Saratov
Country
Russian Federation
Facility Name
Sandoz Investigative Site
City
Smolensk
Country
Russian Federation
Facility Name
Sandoz Investigative Site
City
St. Petersburg
Country
Russian Federation
Facility Name
Sandoz Investigative Site
City
Yaroslavl
Country
Russian Federation
Facility Name
Sandoz Investigative Site
City
Yekaterinburg
Country
Russian Federation
Facility Name
Sandoz Investigative Site
City
Adana
Country
Turkey
Facility Name
Sandoz Investigative Site
City
Ankara
Country
Turkey
Facility Name
Sandoz Investigative Site
City
Istanbul
Country
Turkey
Facility Name
Sandoz Investigative Site
City
Chernovtsy
Country
Ukraine
Facility Name
Sandoz Investigative Site
City
Dnipropetrovsk
Country
Ukraine
Facility Name
Sandoz Investigative Site
City
Donetsk
Country
Ukraine
Facility Name
Sandoz Investigative Site
City
Ivano-Frankivsk
Country
Ukraine
Facility Name
Sandoz Investigative Site
City
Kharkiv
Country
Ukraine
Facility Name
Sandoz Investigative Site
City
Kyiv
Country
Ukraine
Facility Name
Sandoz Investigative Site
City
Lugansk
Country
Ukraine
Facility Name
Sandoz Investigative Site
City
Nikolaev
Country
Ukraine
Facility Name
Sandoz Investigative Site
City
Poltava
Country
Ukraine
Facility Name
Sandoz Investigative Site
City
Ternopil
Country
Ukraine
Facility Name
Sandoz Investigative Site
City
Uzhgorod
Country
Ukraine
Facility Name
Sandoz Investigative Site
City
Zaporizhya
Country
Ukraine
Facility Name
Sandoz Investigative Site
City
Zhitomyr
Country
Ukraine
12. IPD Sharing Statement
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HX575 Epoetin Alfa Subcutaneously (s.c.) in Chronic Kidney Disease (CKD)
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