Post-authorization Safety Study in CKD Subjects Receiving HX575 i.v. (EPO-PASS)

Sandoz

Status and phase: Completed; Phase 4

Conditions: Chronic Kidney Disease

Treatments: Drug: HX575 recombinant human erythropoietin alfa

Study type: Interventional

Funder types: Industry

Identifiers

NCT00632125

2006-66-INJ-14

Details and patient eligibility

About

Cumulative follow-up with HX575 epoetin alfa to prospectively monitor the incidence of relevant drug-related adverse events and EPO-related lack of efficacy among Chronic Kidney Disease (CKD) subjects receiving HX575 epoetin alfa i.v.

Full description

This study was a multi-center, multinational, prospective, single-arm clinical study with a 6-month treatment period. The primary objective was to extend the safety database of patients with CKD who receive i.v. HX575 epoetin alfa treatment and to monitor the adverse event (AE) profile under post-approval conditions.

Enrollment: 1,695 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• CKD subjects with or without dialysis treatment
• Age over 18 years
• Subjects requiring i.v. ESA treatment
• Subjects likely to remain on i.v. ESA treatment for 6 months
• Provision of informed consent -

Exclusion criteria

• Systemic immunosuppressive medication or any other drugs known to adversely affect the hemoglobin level
• Known primary lack of efficacy (LOE), unexplained loss of effect to a recombinant erythropoietin product
• History of PRCA or aplastic anemia
• History of anti-erythropoietin antibodies
• Uncontrolled hypertension
• Pregnant woman or nursing mother
• Women of childbearing potential do not agree to maintain effective birth control during the study treatment period.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

1,695 participants in 1 patient group

HX575 epoetin alfa i.v.

Experimental group

Description:

This post-authorization safety study was designed as a multi-center, multinational, prospective, single-arm clinical study with a 6-month HX575 (recombinant human) erythropoietin alfa treatment period. It was planned to include approximately 1,500 patients.

Treatment:

Drug: HX575 recombinant human erythropoietin alfa