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. - Dynepo long-term safety study
- Conditions
- Anaemia in Chronic Kidney Disease (CKD)
- Registration Number
- EUCTR2007-000054-31-GB
- Lead Sponsor
- Shire
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 416
Patients who complete Dynepo study SPD490-301.
Patients who continue to require epoetin (EPO) treatment and have had a Hb level of >=10g/dL at Week 20 of study SPD490-301.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Withdrawal, before Week 24, from 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method