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Dynepo Long-Term Safety Study

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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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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