Dynepo Long-Term Safety Study

Anemia Clinical Trial

Official title:

An Open-Label, Phase IV, Multi-Centre Study to Investigate the Long-Term Safety and Efficacy of Subcutaneous Dynepo in Adult Patients With Anaemia Associated With Chronic Kidney Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00514813
• Other study ID #: SPD490-402
• Secondary ID: 2007-000054-31
• Status: Terminated
• Phase: Phase 4
• Start date: June 6, 2007
• Est. completion date: July 31, 2008

Study information

• Verified date: June 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 152
• Est. completion date: July 31, 2008
• Est. primary completion date: July 31, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anemia
• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

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

Locations

Country	Name	City	State
Belgium	Heilig Hartziekenhuis Department of Nephrology	Lier

Sponsors (1)

Lead Sponsor	Collaborator
Shire

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Emergence of Treatment Emergent Adverse Events (TEAEs)		Over the course of 2 Years
Secondary	Change From Baseline in Hemoglobin (Hb) Concentrations at 2 Years		Baseline and 2 years
Secondary	Change From Baseline in Hematocrits at 2 Years		Baseline and 2 years