Dynepo Infrequent Dosing Study

This study has been terminated.
(The termination of the study is not linked to a product recall or result of any safety signal. Rather it was sponsor's commercial decision to withdraw the MA)
Sponsor:
Information provided by:
Shire
ClinicalTrials.gov Identifier:
NCT00450333
First received: March 21, 2007
Last updated: June 6, 2014
Last verified: November 2009
  Purpose

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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Shire:

Primary Outcome Measures:
  • Change From Baseline in Hemoglobin (Hb) Concentration at 24 Weeks [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Number of Patients Who Achieve Hb Levels of > or Equal to 11 g/dL [ Time Frame: week 16 and 24 ] [ Designated as safety issue: Yes ]
    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.

  • Change From Baseline in Hematocrits at 16 and 24 Weeks [ Time Frame: Baseline and Weeks 16 and 24 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 407
Study Start Date: October 2006
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Erythropoietin(EPO)-naive BIW
Drug: Dynepo (Epoetin delta)
subcutaneous, BIW for 24 weeks
Active Comparator: 2
EPO-naive QW
Drug: Dynepo
subcutaneous, QW for 24 weeks
Active Comparator: 3
EPO QW
Drug: Dynepo
subcutaneous, QW for 24 weeks
Active Comparator: 4
EPO Q2W
Drug: Dynepo
subcutaneous, Q2W for 24 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00450333

  Show 53 Study Locations
Sponsors and Collaborators
Shire
Investigators
Principal Investigator: Iain C Macdougall, MD Kings College Hospital, London
  More Information

No publications provided

Responsible Party: Timothy Whitaker, M.D., Shire
ClinicalTrials.gov Identifier: NCT00450333     History of Changes
Other Study ID Numbers: SPD490-301, 2006-002052-15
Study First Received: March 21, 2007
Results First Received: August 18, 2009
Last Updated: June 6, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Shire:
Chronic

Additional relevant MeSH terms:
Anemia
Renal Insufficiency
Renal Insufficiency, Chronic
Hematologic Diseases
Kidney Diseases
Urologic Diseases
Epoetin Alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014