An Open-Label, Phase IV, Multi-Centre Study to Investigate theLong-Term Safety and Efficacy of Subcutaneous Dynepo in AdultPatients with Anaemia Associated with Chronic Kidney Disease. - SPD490-402

Conditions: Anemia in Chronic Kidney Disease (CKD)
MedDRA version: 6.1Level: PTClassification code 10002073

Registration Number: EUCTR2007-000054-31-IT

Lead Sponsor: Shire

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 416

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.
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) no
F.1.3.1 Number of subjects for this age range

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 clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the incidence rate of Treatment Emergent Adverse Events (TEAEs) over 2 years in patients treated<br><br>with Dynepo.;Primary end point(s): Rate of emergence of TEAEs over the course of the study.;Secondary Objective: 1. To assess long-term safety, as measured by safety parameters other than reported Adverse Events (AEs),<br><br>but including antibody (Ab) responses to Dynepo.<br><br>2. To assess maintenance of efficacy in long-term usage of Dynepo.<br><br>3. To summarise differences in dose requirements according to dialysis status.<br><br>4. To compare dose requirements between dose schedules.<br><br>5. To summarise efficacy and safety in patients with diabetes mellitus (DM).<br><br>6. To evaluate changes in diabetic retinopathy.

Secondary Outcome Measures