Status:
TERMINATED
Dynepo Infrequent Dosing Study
Lead Sponsor:
Shire
Conditions:
Anemia
Kidney Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 h...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 30 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2008
Estimated Enrollment :
407 Patients enrolled
Trial Details
Trial ID
NCT00450333
Start Date
October 30 2006
End Date
July 31 2008
Last Update
June 14 2021
Active Locations (53)
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1
Med.Univ-Klinik/Klin. Abt.f.Nephrologie u. Hamodialyse
Graz, Steiemark, Austria, A-8036
2
Univ.-Klinik für Innere Medizin/Klin. Abt. für Nephrologie
Innsbruck, Austria, A-6020
3
Hopital UCL, Service de Nephrologie
Brussels, Belgium, B-1200
4
UZ Gasthuisberg, Leuve, Dept of Nephrology
Leuven, Belgium, B-3000