HX575 Epoetin Alfa Subcutaneously (s.c.) in Chronic Kidney Disease (CKD)
SENSE
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
2 other identifiers
interventional
417
7 countries
50
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2012
Typical duration for phase_3
50 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 5, 2012
CompletedFirst Posted
Study publicly available on registry
April 12, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedResults Posted
Study results publicly available
June 19, 2017
CompletedJune 19, 2017
April 1, 2017
2.5 years
April 5, 2012
April 3, 2017
April 4, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Anti-Erythropoietin (EPO) Antibodies
The incidence of antibody formation against epoetin in Radio-immuno-precipitation (RIP) assay
52 weeks
Secondary Outcomes (1)
Hemoglobin Level and Change From Baseline Period at Visit 16 (End of Study)
52 weeks
Study Arms (1)
HX575 epoetin alfa (Sandoz)
EXPERIMENTALSingle arm
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sandozlead
Study Sites (50)
Sandoz Investigative Site
Düsseldorf, Germany
Sandoz Investigative Site
Homberg (Efze), Germany
Sandoz Investigative Site
Nettetal, Germany
Sandoz Investigative Site
Bari, Italy
Sandoz Investigative Site
Częstochowa, Poland
Sandoz Investigative Site
Gdansk, Poland
Sandoz Investigative Site
Gdynia, Poland
Sandoz Investigative Site
Olkusz, Poland
Sandoz Investigative Site
Poznan, Poland
Sandoz Investigative Site
Płock, Poland
Sandoz Investigative Site
Wadowice, Poland
Sandoz Investigative Site
Warzawa, Poland
Sandoz Investigative Site
Bucharest, Romania
Sandoz Investigative Site
Constanța, Romania
Sandoz Investigative Site
Lasi, Romania
Sandoz Investigative Site
Oradea, Romania
Sandoz Investigative Site
Timișoara, Romania
Sandoz Investigative Site
Chelyabinsk, Russia
Sandoz Investigative Site
Kemerovo, Russia
Sandoz Investigative Site
Kolomna, Russia
Sandoz Investigative Site
Moscow, Russia
Sandoz Investigative Site
Mytischi, Russia
Sandoz Investigative Site
Nizhny Novgorod, Russia
Sandoz Investigative Site
Novosibirsk, Russia
Sandoz Investigative Site
Orenburg, Russia
Sandoz Investigative Site
Petrozavodsk, Russia
Sandoz Investigative Site
Podolsk, Russia
Sandoz Investigative Site
Pyatigorsk, Russia
Sandoz Investigative Site
Ryazan, Russia
Sandoz Investigative Site
Saint Petersburg, Russia
Sandoz Investigative Site
Saratov, Russia
Sandoz Investigative Site
Smolensk, Russia
Sandoz Investigative Site
Yaroslavl, Russia
Sandoz Investigative Site
Yekaterinburg, Russia
Sandoz Investigative Site
Adana, Turkey (Türkiye)
Sandoz Investigative Site
Ankara, Turkey (Türkiye)
Sandoz Investigative Site
Istanbul, Turkey (Türkiye)
Sandoz Investigative Site
Chernivtsi, Ukraine
Sandoz Investigative Site
Dnipropetrovsk, Ukraine
Sandoz Investigative Site
Donetsk, Ukraine
Sandoz Investigative Site
Ivano-Frankivsk, Ukraine
Sandoz Investigative Site
Kharkiv, Ukraine
Sandoz Investigative Site
Kyiv, Ukraine
Sandoz Investigative Site
Luhansk, Ukraine
Sandoz Investigative Site
Mykolayiv, Ukraine
Sandoz Investigative Site
Poltava, Ukraine
Sandoz Investigative Site
Ternopil, Ukraine
Sandoz Investigative Site
Uzhhorod, Ukraine
Sandoz Investigative Site
Zaporizhya, Ukraine
Sandoz Investigative Site
Zhitomyr, Ukraine
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Biopharmaceutical Clinical Development, Strategic Planning
- Organization
- Sandoz
Study Officials
- STUDY CHAIR
Sandoz Biopharmaceuticals
Sandoz
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 5, 2012
First Posted
April 12, 2012
Study Start
April 1, 2012
Primary Completion
October 1, 2014
Study Completion
June 1, 2015
Last Updated
June 19, 2017
Results First Posted
June 19, 2017
Record last verified: 2017-04