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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00632125
First Posted: March 10, 2008
Last Update Posted: July 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Hexal AG
Information provided by (Responsible Party):
Sandoz
  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 Chronic Kidney Disease (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: Intervention Model: Single Group Assignment
Masking: None (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 Sandoz:

Primary Outcome Measures:
  • 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


Enrollment: 1695
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: HX575 epoetin alfa i.v.
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.
Drug: HX575 recombinant human erythropoietin alfa
HX575 epoetin alfa i.v. will be administered according to the SmPC
Other Name: HX575 epoetin alfa

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00632125


  Show 114 Study Locations
Sponsors and Collaborators
Sandoz
Hexal AG
Investigators
Study Chair: Karsten Roth, Dr Hexal AG
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sandoz
ClinicalTrials.gov Identifier: NCT00632125     History of Changes
Other Study ID Numbers: 2006-66-INJ-14
First Submitted: February 29, 2008
First Posted: March 10, 2008
Results First Submitted: April 3, 2017
Results First Posted: July 11, 2017
Last Update Posted: July 11, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Epoetin Alfa
Hematinics