Dynepo Long-Term Safety Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

152 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-06

Study Completion Date

2008-07-31

Brief Summary

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

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Detailed Description

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Conditions

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Anemia Kidney Failure, Chronic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Dynepo

Intervention Type DRUG

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

Interventions

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Dynepo

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

Intervention Type DRUG

Other Intervention Names

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Epoetin delta

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No