Dynepo Long-Term Safety Study

This study has been 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)
Sponsor:
Information provided by:
Shire
ClinicalTrials.gov Identifier:
NCT00514813
First received: August 9, 2007
Last updated: June 6, 2014
Last verified: November 2009
  Purpose

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


Condition Intervention Phase
Anemia
Kidney Failure, Chronic
Drug: Dynepo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Shire:

Primary Outcome Measures:
  • Rate of Emergence of Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Over the course of 2 Years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change From Baseline in Hemoglobin (Hb) Concentrations at 2 Years [ Time Frame: Baseline and 2 years ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Hematocrits at 2 Years [ Time Frame: Baseline and 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 152
Study Start Date: June 2007
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  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: 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
  More Information

No publications provided

Responsible Party: Timothy Whitaker, M.D., Shire
ClinicalTrials.gov Identifier: NCT00514813     History of Changes
Other Study ID Numbers: SPD490-402, 2007-000054-31
Study First Received: August 9, 2007
Results First Received: August 18, 2009
Last Updated: June 6, 2014
Health Authority: Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment

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

ClinicalTrials.gov processed this record on July 10, 2014