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

Phase 4

Completed

• Conditions: Chronic Kidney Disease
• Interventions: Drug: HX575 recombinant human erythropoietin alfa

• Registration Number: NCT00632125
• Lead Sponsor: Sandoz

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2008-02-29
• Study First Submitted QC: 2008-03-07
• Study First Posted: 2008-03-10
• Study Start: 2008-07
• Primary Completion: 2010-03
• Study Completion: 2010-09
• Results First Submitted: 2017-04-03
• Status Verified: 2017-07
• Results First Submitted QC: 2017-07-10
• Last Update Submitted: 2017-07-10
• Results First Posted: 2017-07-11
• Last Update Posted: 2017-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1695

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HX575 epoetin alfa i.v.	HX575 recombinant human erythropoietin alfa	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.

Primary Outcome Measures

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

Trial Locations

Locations (104)

Dialysepraxis Dres. Huspek/Schmid; 🇦🇹 Bad Ischl, Austria

Landeskrankenhaus Feldkirch; 🇦🇹 Feldkirch, Austria

Landeskrankenhaus Freistadt; 🇦🇹 Freistadt, Austria

LKH Rohrbach; 🇦🇹 Rohrbach, Austria

Universitätsklinik für Innere Medizin III; 🇦🇹 Wien, Austria

Multiprofile Hospital for Active Treatment Dr. Tota Venkova; 🇧🇬 Gabrovo, Bulgaria

Multiprofile Hospital for Active Treatment Dr. Kiro Popov; 🇧🇬 Karlovo, Bulgaria

Multiprofile Hospital for Active Treatment Pazardzhik; 🇧🇬 Pazardzhik, Bulgaria

Multiprofile Hospital for Active Treatment Rousse; 🇧🇬 Rousse, Bulgaria

Multiprofile Hospital for Active Treatment Sv. Ivan Rilski; 🇧🇬 Sofia, Bulgaria

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