Dynepo Infrequent Dosing Study

• Status: Terminated
• Trial end date: 2008-07-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to demonstrate non-inferiority of efficacy between twice weekly and once weekly dose schedule of Dynepo in previously erythropoietin (EPO)-naive patients, as measured by haemoglobin at week 24 and secondly to demonstrate the non-inferiority of efficacy between once weekly and once every two weeks dose schedules of Dynepo in patients previously stable on EPO, as measured by Hb over Weeks 16 to 24.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shire
• Treatments: Epoetin Alfa

Criteria

Inclusion Criteria:

• Aged at least 18 years with chronic kidney disease (Kidney Disease Outcomes Quality Initiative [KDOQI] stage III-V).

• Stable on and taking doses <= 10,000 IU/week of subcutaneous (sc) EPO or requiring initiation of EPO.

• Transferrin saturation >= 20% and ferritin >= 100 ng/mL.

Exclusion Criteria:

• Uncontrolled hypertension.

• Requiring doses of EPO > 10,000 IU/week.

• Two or more doses of prescribed EPO treatment missed ot withheld by physician order in the 14 days immediately prior tp randomisation in the study.

• Active bleeding disorder (diathesis) (for example, Gastrointestinal or Genitourinary tract bleeding).

• Treatment with immunosuppressive drugs (other than corticosteroids for a chronic condition) in the 30 days immediately prior to randomisation in the study.

• Androgen therapy in the 30 days immediately prior to randomisation in the study.

• Known Human Immunodeficiency Virus(HIV)infection.

• History of hypersensitivity to EPO therapy or to any of the excipients of Dynepo.