Dynepo Long-Term Safety Study

Shire

Status and phase: Terminated; Phase 4

Conditions: Anemia; Kidney Failure, Chronic

Treatments: Drug: Dynepo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00514813

2007-000054-31 (EudraCT Number)

SPD490-402

Details and patient eligibility

About

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

Enrollment: 152 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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152 participants in 1 patient group

Dynepo (Epoetin delta)

Experimental group

Description:

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

Treatment:

Drug: Dynepo