Dynepo Long-Term Safety Study

Phase 4

Terminated

• Conditions: Anemia; Kidney Failure, Chronic
• Interventions: Drug: Dynepo

• Registration Number: NCT00514813
• Lead Sponsor: Shire

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06-06
• Study First Submitted: 2007-08-09
• Study First Submitted QC: 2007-08-09
• Study First Posted: 2007-08-10
• Primary Completion: 2008-07-31
• Study Completion: 2008-07-31
• Results First Submitted: 2009-08-18
• Results First Submitted QC: 2009-09-29
• Results First Posted: 2009-11-09
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-21
• Last Update Posted: 2021-07-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 152

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dynepo (Epoetin delta)	Dynepo	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

Primary Outcome Measures

Name	Time	Method
Rate of Emergence of Treatment Emergent Adverse Events (TEAEs)	Over the course of 2 Years

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Hemoglobin (Hb) Concentrations at 2 Years	Baseline and 2 years
Change From Baseline in Hematocrits at 2 Years	Baseline and 2 years

Trial Locations

Locations (1)

Heilig Hartziekenhuis Department of Nephrology; 🇧🇪 Lier, Belgium