Clinical trial NCT01576341: HX575 Epoetin Alfa Subcutaneously (s.c.) in Chronic Kidney Disease (CKD)
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Kidney Disease
Keywords: Epoetin alfa, ESA, HX575, CKD
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2012-04-12
Enrollment: 417
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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)


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

Primary outcomes:
measure: Anti-Erythropoietin (EPO) Antibodies
timeFrame: 52 weeks
Secondary outcomes:
measure: Hemoglobin Level and Change From Baseline Period at Visit 16 (End of Study)
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Duesseldorf
country: Germany
facility: Sandoz Investigative Site
city: Homberg
country: Germany
facility: Sandoz Investigative Site
city: Nettetal
country: Germany
facility: Sandoz Investigative Site
city: Bari
country: Italy
facility: Sandoz Investigative Site
city: Czestochowa
country: Poland
facility: Sandoz Investigative Site
city: Gdansk
country: Poland
facility: Sandoz Investigative Site
city: Gdynia
country: Poland
facility: Sandoz Investigative Site
city: Olkusz
country: Poland
facility: Sandoz Investigative Site
city: Plock
country: Poland
facility: Sandoz Investigative Site
city: Poznan
country: Poland
facility: Sandoz Investigative Site
city: Wadowice
country: Poland
facility: Sandoz Investigative Site
city: Warzawa
country: Poland
facility: Sandoz Investigative Site
city: Bucuresti
country: Romania
facility: Sandoz Investigative Site
city: Constanta
country: Romania
facility: Sandoz Investigative Site
city: Lasi
country: Romania
facility: Sandoz Investigative Site
city: Oradea
country: Romania
facility: Sandoz Investigative Site
city: Timisoara
country: Romania
facility: Sandoz Investigative Site
city: Chelyabinsk
country: Russian Federation
facility: Sandoz Investigative Site
city: Kemerovo
country: Russian Federation
facility: Sandoz Investigative Site
city: Kolomna
country: Russian Federation
facility: Sandoz Investigative Site
city: Moscow
country: Russian Federation
facility: Sandoz Investigative Site
city: Mytischi
country: Russian Federation
facility: Sandoz Investigative Site
city: Nizhny Novgorod
country: Russian Federation
facility: Sandoz Investigative Site
city: Novosibirsk
country: Russian Federation
facility: Sandoz Investigative Site
city: Orenburg
country: Russian Federation
facility: Sandoz Investigative Site
city: Petrozavodsk
country: Russian Federation
facility: Sandoz Investigative Site
city: Podolsk
country: Russian Federation
facility: Sandoz Investigative Site
city: Pyatigorsk
country: Russian Federation
facility: Sandoz Investigative Site
city: Ryazan
country: Russian Federation
facility: Sandoz Investigative Site
city: Saratov
country: Russian Federation
facility: Sandoz Investigative Site
city: Smolensk
country: Russian Federation
facility: Sandoz Investigative Site
city: St. Petersburg
country: Russian Federation
facility: Sandoz Investigative Site
city: Yaroslavl
country: Russian Federation
facility: Sandoz Investigative Site
city: Yekaterinburg
country: Russian Federation
facility: Sandoz Investigative Site
city: Adana
country: Turkey
facility: Sandoz Investigative Site
city: Ankara
country: Turkey
facility: Sandoz Investigative Site
city: Istanbul
country: Turkey
facility: Sandoz Investigative Site
city: Chernovtsy
country: Ukraine
facility: Sandoz Investigative Site
city: Dnipropetrovsk
country: Ukraine
facility: Sandoz Investigative Site
city: Donetsk
country: Ukraine
facility: Sandoz Investigative Site
city: Ivano-Frankivsk
country: Ukraine
facility: Sandoz Investigative Site
city: Kharkiv
country: Ukraine
facility: Sandoz Investigative Site
city: Kyiv
country: Ukraine
facility: Sandoz Investigative Site
city: Lugansk
country: Ukraine
facility: Sandoz Investigative Site
city: Nikolaev
country: Ukraine
facility: Sandoz Investigative Site
city: Poltava
country: Ukraine
facility: Sandoz Investigative Site
city: Ternopil
country: Ukraine
facility: Sandoz Investigative Site
city: Uzhgorod
country: Ukraine
facility: Sandoz Investigative Site
city: Zaporizhya
country: Ukraine
facility: Sandoz Investigative Site
city: Zhitomyr
country: Ukraine
facility: Sandoz Investigative Site
Study officials:
affiliation: Sandoz
name: Sandoz Biopharmaceuticals
role: STUDY_CHAIR
References: