Post-authorization Safety Study in CKD Subjects Receiving HX575 i.v.

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.

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Key information

Conditions

Chronic Kidney Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Dialysepraxis Dres. Huspek/Schmid, Bad Ischl, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HX575 recombinant human erythropoietin alfa

Drug

HX575 epoetin alfa i.v. will be administered according to the SmPC

Other names: HX575 epoetin alfa

Primary outcomes

Drug-related Adverse Events Consisting of Epoetin Alfa-induced Immunogenicity and Resulting Clinical Effects

Time frame: 6 months

The incidence of relevant drug-related adverse events consisting of Epoetin alfa-induced immunogenicity and resulting blockade in erythroid maturation (e.g. pure red cell aplasia) and lack of efficacy

Sponsors and collaborators

Lead sponsor

Sandoz

Industry

Collaborators

Hexal AG

Registry information

Official study title

Post-authorization Safety Study to Prospectively Monitor the Incidence of Relevant Drug-related Adverse Events and EPO-related Lack of Efficacy Among CKD Subjects Receiving HX575 Recombinant Human Erythropoietin Alfa i.v.

Acronym: EPO-PASS

Important dates

Study start: 2008
Primary completion: 2010
Study completion: 2010
First posted: Mar 10, 2008
Registry last updated: Jul 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed