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

Information source: Sandoz
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Kidney Disease

Intervention: HX575 epoetin alfa (Sandoz) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Sandoz

Official(s) and/or principal investigator(s):
Sandoz Biopharmaceuticals, Study Chair, Affiliation: Sandoz

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)

Clinical Details

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 design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Incidence of antibody formation against epoetin

Secondary outcome:

Hemoglobin levels over time and change from baseline

Weekly epoetin dosage (IU and IU/kg) over time and change from baseline

Incidence and severity of AEs, and of drug related AEs

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Sandoz Investigative Site, Duesseldorf, Germany

Sandoz Investigative Site, Homberg, Germany

Sandoz Investigative Site, Nettetal, Germany

Sandoz Investigative Site, Bari, Italy

Sandoz Investigative Site, Czestochowa, Poland

Sandoz Investigative Site, Gdansk, Poland

Sandoz Investigative Site, Gdynia, Poland

Sandoz Investigative Site, Olkusz, Poland

Sandoz Investigative Site, Plock, Poland

Sandoz Investigative Site, Poznan, Poland

Sandoz Investigative Site, Wadowice, Poland

Sandoz Investigative Site, Warzawa, Poland

Sandoz Investigative Site, Bucuresti, Romania

Sandoz Investigative Site, Constanta, Romania

Sandoz Investigative Site, Lasi, Romania

Sandoz Investigative Site, Oradea, Romania

Sandoz Investigative Site, Timisoara, Romania

Sandoz Investigative Site, Chelyabinsk, Russian Federation

Sandoz Investigative Site, Kemerovo, Russian Federation

Sandoz Investigative Site, Kolomna, Russian Federation

Sandoz Investigative Site, Moscow, Russian Federation

Sandoz Investigative Site, Mytischi, Russian Federation

Sandoz Investigative Site, Nizhny Novgorod, Russian Federation

Sandoz Investigative Site, Novosibirsk, Russian Federation

Sandoz Investigative Site, Orenburg, Russian Federation

Sandoz Investigative Site, Petrozavodsk, Russian Federation

Sandoz Investigative Site, Podolsk, Russian Federation

Sandoz Investigative Site, Pyatigorsk, Russian Federation

Sandoz Investigative Site, Ryazan, Russian Federation

Sandoz Investigative Site, Saratov, Russian Federation

Sandoz Investigative Site, Smolensk, Russian Federation

Sandoz Investigative Site, St. Petersburg, Russian Federation

Sandoz Investigative Site, Yaroslavl, Russian Federation

Sandoz Investigative Site, Yekaterinburg, Russian Federation

Sandoz Investigative Site, Adana, Turkey

Sandoz Investigative Site, Ankara, Turkey

Sandoz Investigative Site, Istanbul, Turkey

Sandoz Investigative Site, Chernovtsy, 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, Lugansk, Ukraine

Sandoz Investigative Site, Nikolaev, Ukraine

Sandoz Investigative Site, Poltava, Ukraine

Sandoz Investigative Site, Ternopil, Ukraine

Sandoz Investigative Site, Uzhgorod, Ukraine

Sandoz Investigative Site, Zaporizhya, Ukraine

Sandoz Investigative Site, Zhitomyr, Ukraine

Additional Information

Starting date: April 2012
Last updated: June 18, 2015

Page last updated: August 23, 2015

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