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HX575 Epoetin Alfa Subcutaneously (s.c.) in Chronic Kidney Disease (CKD)

NCT ID: NCT01576341

Last Updated: 2017-06-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

417 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2015-06-30

Brief Summary

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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)

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Detailed Description

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Conditions

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Chronic Kidney Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HX575 epoetin alfa (Sandoz)

Single arm

Group Type EXPERIMENTAL

HX575 epoetin alfa (Sandoz)

Intervention Type DRUG

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.

Interventions

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HX575 epoetin alfa (Sandoz)

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.

Intervention Type DRUG

Other Intervention Names

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Binocrit®, Epoetin alfa HEXAL®, Novicrit®, Abseamed®

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sandoz

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sandoz Biopharmaceuticals

Role: STUDY_CHAIR

Sandoz

Locations

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Sandoz Investigative Site

Düsseldorf, , Germany

Site Status

Sandoz Investigative Site

Homberg (Efze), , Germany

Site Status

Sandoz Investigative Site

Nettetal, , Germany

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Sandoz Investigative Site

Bari, , Italy

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Sandoz Investigative Site

Częstochowa, , Poland

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Sandoz Investigative Site

Gdansk, , Poland

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Sandoz Investigative Site

Gdynia, , Poland

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Sandoz Investigative Site

Olkusz, , Poland

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Sandoz Investigative Site

Poznan, , Poland

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Sandoz Investigative Site

Płock, , Poland

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Sandoz Investigative Site

Wadowice, , Poland

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Sandoz Investigative Site

Warzawa, , Poland

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Sandoz Investigative Site

Bucharest, , Romania

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Sandoz Investigative Site

Constanța, , Romania

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Sandoz Investigative Site

Lasi, , Romania

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Sandoz Investigative Site

Oradea, , Romania

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Sandoz Investigative Site

Timișoara, , Romania

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Sandoz Investigative Site

Chelyabinsk, , Russia

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Sandoz Investigative Site

Kemerovo, , Russia

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Sandoz Investigative Site

Kolomna, , Russia

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Sandoz Investigative Site

Moscow, , Russia

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Sandoz Investigative Site

Mytischi, , Russia

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Sandoz Investigative Site

Nizhny Novgorod, , Russia

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Sandoz Investigative Site

Novosibirsk, , Russia

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Sandoz Investigative Site

Orenburg, , Russia

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Sandoz Investigative Site

Petrozavodsk, , Russia

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Sandoz Investigative Site

Podolsk, , Russia

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Sandoz Investigative Site

Pyatigorsk, , Russia

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Sandoz Investigative Site

Ryazan, , Russia

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Sandoz Investigative Site

Saint Petersburg, , Russia

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Sandoz Investigative Site

Saratov, , Russia

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Sandoz Investigative Site

Smolensk, , Russia

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Sandoz Investigative Site

Yaroslavl, , Russia

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Sandoz Investigative Site

Yekaterinburg, , Russia

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Sandoz Investigative Site

Adana, , Turkey (Türkiye)

Site Status

Sandoz Investigative Site

Ankara, , Turkey (Türkiye)

Site Status

Sandoz Investigative Site

Istanbul, , Turkey (Türkiye)

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Sandoz Investigative Site

Chernivtsi, , Ukraine

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Sandoz Investigative Site

Dnipropetrovsk, , Ukraine

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Sandoz Investigative Site

Donetsk, , Ukraine

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Sandoz Investigative Site

Ivano-Frankivsk, , Ukraine

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Sandoz Investigative Site

Kharkiv, , Ukraine

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Sandoz Investigative Site

Kyiv, , Ukraine

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Sandoz Investigative Site

Luhansk, , Ukraine

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Sandoz Investigative Site

Mykolayiv, , Ukraine

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Sandoz Investigative Site

Poltava, , Ukraine

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Sandoz Investigative Site

Ternopil, , Ukraine

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Sandoz Investigative Site

Uzhhorod, , Ukraine

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Sandoz Investigative Site

Zaporizhya, , Ukraine

Site Status

Sandoz Investigative Site

Zhitomyr, , Ukraine

Site Status

Countries

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Germany Italy Poland Romania Russia Turkey (Türkiye) Ukraine

Other Identifiers

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2011-002871-40

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

HX575-308

Identifier Type: -

Identifier Source: org_study_id

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