Dynepo Infrequent Dosing Study

Study Overview
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Brief Summary
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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.

Official Title
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An Open-Label, Phase IIIb, Multi-Centre, Randomised, Parallel-Group Study to Investigate the Efficacy and Safety of Three Dosing Schedules of Subcutaneous Dynepo in Adult Patients With Anaemia Associated With Chronic Kidney Disease Who Are Pre-Dialysis or Require Peritoneal Dialysis or Haemodialysis

Conditions
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Anemia, Kidney Failure

Intervention / Treatment
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* Drug: Dynepo (Epoetin delta)
* Drug: Dynepo
* Drug: Dynepo
* Drug: Dynepo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Erythropoietin(EPO)-naive BIW | Drug: Dynepo (Epoetin delta)<br>* subcutaneous, BIW for 24 weeks<br>|
| Active Comparator: 2<br>EPO-naive QW | Drug: Dynepo<br>* subcutaneous, QW for 24 weeks<br>|
| Active Comparator: 3<br>EPO QW | Drug: Dynepo<br>* subcutaneous, QW for 24 weeks<br>|
| Active Comparator: 4<br>EPO Q2W | Drug: Dynepo<br>* subcutaneous, Q2W for 24 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Hemoglobin (Hb) Concentration at 24 Weeks | This study terminated early due to a decision by Shire Pharmaceuticals to permanently cease marketing Dynepo due to commercial reasons, it was not the result of any safety signal. Not enough subjects completed the study to do any efficacy analyses. | Baseline and 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients Who Achieve Hb Levels of > or Equal to 11 g/dL | This study terminated early due to a decision by Shire Pharmaceuticals to permanently cease marketing Dynepo due to commercial reasons, it was not the result of any safety signal. Not enough subjects completed the study to do any efficacy analyses. | week 16 and 24 | 
| Change From Baseline in Hematocrits at 16 and 24 Weeks | This study terminated early due to a decision by Shire Pharmaceuticals to permanently cease marketing Dynepo due to commercial reasons, it was not the result of any safety signal. Not enough subjects completed the study to do any efficacy analyses. | Baseline and Weeks 16 and 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic