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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Renal Insufficiency
Urologic Diseases
Epoetin alfa
Hematinics
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014