NCT00450333

Dynepo Infrequent Dosing Study

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 407 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anemia
• Kidney Failure

Interventions

Type	Name	Description
DRUG	Dynepo (Epoetin delta)	subcutaneous, BIW for 24 weeks
DRUG	Dynepo	subcutaneous, QW for 24 weeks
DRUG	Dynepo	subcutaneous, QW for 24 weeks
DRUG	Dynepo	subcutaneous, Q2W for 24 weeks

Timeline

• Start date: 2006-10-30
• Primary completion: 2008-07-31
• Completion: 2008-07-31
• First posted: 2007-03-22
• Last updated: 2021-06-14
• Results posted: 2009-11-10

Locations

53 sites across 7 countries: Austria, Belgium, France, Germany, Italy, Spain, United Kingdom