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

Chronic Kidney Disease Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01576341
• Other study ID #: HX575-308
• Secondary ID: 2011-002871-40
• Status: Completed
• Phase: Phase 3
• First received: April 5, 2012
• Last updated: November 11, 2015
• Start date: April 2012
• Est. completion date: June 2015

Study information

• Verified date: November 2015
• Source: Sandoz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 417
• Est. completion date: June 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Germany	Sandoz Investigative Site	Duesseldorf
Germany	Sandoz Investigative Site	Homberg
Germany	Sandoz Investigative Site	Nettetal
Italy	Sandoz Investigative Site	Bari
Poland	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
Romania	Sandoz Investigative Site	Bucuresti
Romania	Sandoz Investigative Site	Constanta
Romania	Sandoz Investigative Site	Lasi
Romania	Sandoz Investigative Site	Oradea
Romania	Sandoz Investigative Site	Timisoara
Russian Federation	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
Turkey	Sandoz Investigative Site	Adana
Turkey	Sandoz Investigative Site	Ankara
Turkey	Sandoz Investigative Site	Istanbul
Ukraine	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

Sponsors (1)

Lead Sponsor	Collaborator
Sandoz

Countries where clinical trial is conducted

Germany,  Italy,  Poland,  Romania,  Russian Federation,  Turkey,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of antibody formation against epoetin	The incidence of antibody formation against epoetin will be tabulated with absolute and relative frequencies.	52 weeks	No
Secondary	Hemoglobin levels over time and change from baseline	Mean Hb levels as well as mean changes in Hb levels will be presented by visit.	52 weeks	No
Secondary	Weekly epoetin dosage (IU and IU/kg) over time and change from baseline	The weekly epoetin dose (in total IU epoetin and in IU/kg BW) will be presented as mean time courses as well as absolute changes compared to study week 1.	52 weeks	No
Secondary	Incidence and severity of AEs, and of drug related AEs	Incidences of treatment-emergent AEs and related AEs, treatment-emergent SAEs, and related SAEs will be summarized by MedDRA primary system organ class (SOC) and preferred term overall.	52 weeks	Yes