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

  • Patients who complete Dynepo study SPD490-301.
  • 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

  • Withdrawal, before Week 24, from study SPD490-301.
  • Pregnant or lactating women.
  • Uncontrolled hypertension.
  • Thrombocytopenia (platelet count <75,000/mm3).
  • Active bleeding disorder (diathesis) (for example, gastrointestinal bleeding or genitourinary tract bleeding).
  • Treatment with immunosuppressive drugs (other than corticosteroids for a chronic condition) in the 30 days immediately prior to enrolment in this study.
  • Androgen therapy in the 30 days immediately prior to enrolment in this study.
  • Known Human Immunodeficiency Virus (HIV) infection.
  • History of hypersensitivity to Dynepo.
  • 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

0

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Data sourced from clinicaltrials.gov

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