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

This study has been completed.
Sponsor:
Collaborator:
Hexal AG
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00632125
First received: February 29, 2008
Last updated: November 15, 2010
Last verified: November 2010
  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 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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:


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 ]

Enrollment: 1706
Study Start Date: July 2008
Study Completion Date: September 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: HX575 recombinant human erythropoietin alfa
HX575 epoetin alfa i.v. will be administered according to the SmPC
Other Name: HX575 epoetin alfa

  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 by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hexal AG, Sandoz Biopharmaceuticals Development
ClinicalTrials.gov Identifier: NCT00632125     History of Changes
Other Study ID Numbers: 2006-66-INJ-14
Study First Received: February 29, 2008
Last Updated: November 15, 2010
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 - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Macedonia: Ministry of Health
Poland: Ministry of Health
Romania: National Medicines Agency
Russia: Ministry of Health of the Russian Federation
Ukraine: Ministry of Health

Keywords provided by Novartis:
CKD subjects with or without dialysis treatment

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency
Epoetin Alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 14, 2014