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Sponsored by: |
Shire Pharmaceutical Development |
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Information provided by: | Shire Pharmaceutical Development |
ClinicalTrials.gov Identifier: | NCT00450333 |
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.
Condition | Intervention | Phase |
---|---|---|
Anemia Kidney Failure |
Drug: Dynepo (Epoetin delta) Drug: Dynepo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Enrollment: | 407 |
Study Start Date: | October 2006 |
Estimated Study Completion Date: | January 2009 |
Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
Erythropoietin(EPO)-naive BIW
|
Drug: Dynepo (Epoetin delta)
subcutaneous, BIW for 24 weeks
|
2: Active Comparator
EPO-naive QW
|
Drug: Dynepo
subcutaneous, QW for 24 weeks
|
3: Active Comparator
EPO QW
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Drug: Dynepo
subcutaneous, QW for 24 weeks
|
4: Active Comparator
EPO Q2W
|
Drug: Dynepo
subcutaneous, Q2W for 24 weeks
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Principal Investigator: | Iain C Macdougall, MD | Kings College Hospital, London |
Responsible Party: | Shire ( Timothy Whitaker, M.D. ) |
Study ID Numbers: | SPD490-301 |
Study First Received: | March 21, 2007 |
Last Updated: | November 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00450333 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Chronic |
Epoetin Alfa Renal Insufficiency Urologic Diseases Hematologic Diseases Renal Insufficiency, Chronic |
Anemia Kidney Failure, Chronic Kidney Diseases Kidney Failure |