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

Sandoz

Status and phase: Completed; Phase 3

Conditions: Chronic Kidney Disease

Treatments: Drug: HX575 epoetin alfa (Sandoz)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01576341

HX575-308

2011-002871-40 (EudraCT Number)

Details and patient eligibility

About

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)

Enrollment: 417 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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417 participants in 1 patient group

HX575 epoetin alfa (Sandoz)

Experimental group

Description:

Single arm

Treatment:

Drug: HX575 epoetin alfa (Sandoz)