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

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

This study is ongoing, but not recruiting participants.

First Received: February 29, 2008 Last Updated: August 31, 2009 History of Changes

Sponsors and Collaborators:	Novartis Hexal AG
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00632125

Purpose

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 CKD subjects receiving HX575 epoetin alfa i.v.

Condition	Intervention	Phase
Chronic Kidney Disease	Drug: HX575 recombinant human erythropoietin alfa	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official 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.

Resource links provided by NLM:

Drug Information available for: Erythropoietin Epoetin alfa

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Determination of relevant drug-related adverse events and EPO-related lack of efficacy incidence among CKD subjects receiving HX575 epoetin alfa i.v. [ Time Frame: ongoing ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	1500
Study Start Date:	July 2008
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: HX575 recombinant human erythropoietin alfa HX575 epoetin alfa i.v. will be administered according to the SmPC

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00632125

Show 114 Study Locations

Sponsors and Collaborators

Novartis

Hexal AG

Investigators

Study Chair:

Karsten Roth, Dr

Hexal AG

More Information

No publications provided

Responsible Party:	Sandoz Biopharmaceuticals Development ( Hexal AG )
Study ID Numbers:	2006-66-INJ-14
Study First Received:	February 29, 2008
Last Updated:	August 31, 2009
ClinicalTrials.gov Identifier:	NCT00632125 History of Changes
Health Authority:	Austria: Federal Office for Safety in Health Care; Germany: Ministry of Health; Italy: The Italian Medicines Agency; Bulgaria: Bulgarian Drug Agency; United Kingdom: National Health Service; France: Afssaps - French Health Products Safety Agency; Macedonia: Ministry of Health; Poland: Ministry of Health; Romania: National Medicines Agency; Russia: Ministry of Health and Social Development of the Russian Federation; Ukraine: Ministry of Health

Keywords provided by Novartis:

CKD subjects with or without dialysis treatment

Study placed in the following topic categories:

Epoetin Alfa
Renal Insufficiency
Urologic Diseases
Hematinics

Renal Insufficiency, Chronic
Kidney Failure, Chronic
Kidney Diseases
Kidney Failure

Additional relevant MeSH terms:

Epoetin Alfa
Renal Insufficiency
Urologic Diseases
Hematinics
Renal Insufficiency, Chronic
Therapeutic Uses

Hematologic Agents
Kidney Failure, Chronic
Kidney Diseases
Pharmacologic Actions
Kidney Failure

ClinicalTrials.gov processed this record on September 10, 2009