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NCT00514813 Clinical Trial

Dynepo Long-Term Safety Study

Anemia Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00514813
Other study ID # SPD490-402
Secondary ID 2007-000054-31
Status Terminated
Phase Phase 4
First received
Last updated
Start date June 6, 2007
Est. completion date July 31, 2008

Study information
Verified date June 2021
Source Takeda
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Terminated
Enrollment 152
Est. completion date July 31, 2008
Est. primary completion date July 31, 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Dynepo
Subcutaneous injection either BIW, QW, Q2W or Q4W based on what is appropriate for the subject

Locations
Country Name City State
Belgium Heilig Hartziekenhuis Department of Nephrology Lier

Sponsors (1)
Lead Sponsor Collaborator
Shire

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Rate of Emergence of Treatment Emergent Adverse Events (TEAEs) Over the course of 2 Years
Secondary Change From Baseline in Hemoglobin (Hb) Concentrations at 2 Years Baseline and 2 years
Secondary Change From Baseline in Hematocrits at 2 Years Baseline and 2 years
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