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Dynepo Long-Term Safety Study

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.
ClinicalTrials.gov Identifier: NCT00514813
Recruitment Status : Terminated (The termination of the study is not linked to a product recall or result of any safety signal. Rather it was sponsor's commercial decision to withdraw the MA)
First Posted : August 10, 2007
Results First Posted : November 9, 2009
Last Update Posted : June 12, 2014
Sponsor:
Information provided by:
Shire

Brief Summary:
To assess the incidence rate of Treatment Emergent Adverse Events (TEAEs) over 2 years in patients treated with Dynepo.

Condition or disease Intervention/treatment Phase
Anemia Kidney Failure, Chronic Drug: Dynepo Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 152 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: An Open-Label, Phase IV, Multi-Centre Study to Investigate the Long-Term Safety and Efficacy of Subcutaneous Dynepo in Adult Patients With Anaemia Associated With Chronic Kidney Disease
Study Start Date : June 2007
Primary Completion Date : July 2008
Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Dynepo (Epoetin delta)
Subjects received Dynepo (Epoetin delta) either twice weekly (BIW), once weekly (QW), once every 2 weeks (Q2W) or once every 4 weeks (Q4W) based on what is appropriate for the subject
Drug: Dynepo
Subcutaneous injection either BIW, QW, Q2W or Q4W based on what is appropriate for the subject
Other Name: Epoetin delta



Primary Outcome Measures :
  1. Rate of Emergence of Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Over the course of 2 Years ]

Secondary Outcome Measures :
  1. Change From Baseline in Hemoglobin (Hb) Concentrations at 2 Years [ Time Frame: Baseline and 2 years ]
  2. Change From Baseline in Hematocrits at 2 Years [ Time Frame: Baseline and 2 years ]


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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:

  1. Patients who complete Dynepo study SPD490-301.
  2. Patients who continue to require epoetin (EPO) treatment and have had a Hb level of 10g/dL between Weeks 16 and 24 of study SPD490-301.

Exclusion Criteria:

  1. Withdrawal, before Week 24, from study SPD490-301.
  2. Pregnant or lactating women.
  3. Uncontrolled hypertension.
  4. Thrombocytopenia (platelet count <75,000/mm3).
  5. Active bleeding disorder (diathesis) (for example, gastrointestinal bleeding or genitourinary tract bleeding).
  6. Treatment with immunosuppressive drugs (other than corticosteroids for a chronic condition) in the 30 days immediately prior to enrolment in this study.
  7. Androgen therapy in the 30 days immediately prior to enrolment in this study.
  8. Known Human Immunodeficiency Virus (HIV) infection.
  9. History of hypersensitivity to Dynepo.
  10. Known to have Ab against EPO.

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): NCT00514813


Locations
Belgium
Department of Nephrology
Heilig Hartziekenhuis, Wilgenstraat 2, Belgium
Sponsors and Collaborators
Shire
Investigators
Principal Investigator: Iain C Macdougall, MD Kings College Hospital, London

Responsible Party: Timothy Whitaker, M.D., Shire
ClinicalTrials.gov Identifier: NCT00514813     History of Changes
Other Study ID Numbers: SPD490-402
2007-000054-31 ( EudraCT Number )
First Posted: August 10, 2007    Key Record Dates
Results First Posted: November 9, 2009
Last Update Posted: June 12, 2014
Last Verified: November 2009

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