Dynepo Long-Term Safety Study

Phase 4TerminatedNCT00514813

Shire152 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

152

Conditions

Anemia Kidney Failure, Chronic

Interventions

DynepoDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Heilig Hartziekenhuis Department of Nephrology

Lier, Belgium

Outcomes

Primary Outcomes

Rate of Emergence of Treatment Emergent Adverse Events (TEAEs)

Time frame: Over the course of 2 Years

Secondary Outcomes

Change From Baseline in Hemoglobin (Hb) Concentrations at 2 Years

Time frame: Baseline and 2 years

Change From Baseline in Hematocrits at 2 Years

Time frame: Baseline and 2 years

Data from ClinicalTrials.gov

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