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Dynepo Infrequent Dosing Study

NCT00450333 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 407

Last updated 2021-06-14

Study results available
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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

Interventions

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

Sponsors & Collaborators

  • Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-30
Primary Completion
2008-07-31
Completion
2008-07-31

Countries

  • Austria
  • Belgium
  • France
  • Germany
  • Italy
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00450333 on ClinicalTrials.gov