Dynepo Infrequent Dosing Study - Full Text View

Sponsored by:	Shire Pharmaceutical Development
Information provided by:	Shire Pharmaceutical Development
ClinicalTrials.gov Identifier:	NCT00450333

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 III

MedlinePlus related topics: Anemia Kidney Failure

Drug Information available for: Epoetin alfa Erythropoietin Epoetin delta

U.S. FDA Resources

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

Further study details as provided by Shire Pharmaceutical Development:

Primary Outcome Measures:

Primary endpoint is mean haemoglobin (Hb) concentration [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Number (%) of patients who achieve Hb of >= 11 g/dL [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
Number (%) of patients who achieve the haematocrit (Hct) target range of 33%-36% [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
Number (%) of patients who achieve both Hb of >= 11 g/dL and the Hct target range of 33%-36% [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
Patients' average weekly dose/kg [ Time Frame: Weeks 24 ] [ Designated as safety issue: No ]
Mean Hb concentration [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
Mean Hct concentration [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
Number (%) of patients with a positive antibody response to Dynepo [ Time Frame: Week 24 ] [ Designated as safety issue: Yes ]
Number (%) of patients shown to have neutralising antibodies [ Time Frame: Week 24 ] [ Designated as safety issue: Yes ]
Blood pressure changes from Baseline [ Time Frame: Week 24 ] [ Designated as safety issue: Yes ]
Changes in left ventricular ejection fraction from the Screening visit [ Time Frame: Week 24 ] [ Designated as safety issue: Yes ]
Renal function using the estimated glomerular filtration rate [ Time Frame: Week 24 ] [ Designated as safety issue: Yes ]
Retinopathy in diabetic patients [ Time Frame: Week 24 ] [ Designated as safety issue: Yes ]

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	Drug: Dynepo subcutaneous, QW for 24 weeks
4: Active Comparator 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

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

Show 53 Study Locations

Sponsors and Collaborators

Shire Pharmaceutical Development

Investigators

Principal Investigator:

Iain C Macdougall, MD

Kings College Hospital, London

More Information

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

Keywords provided by Shire Pharmaceutical Development:

Chronic

Study placed in the following topic categories:

Epoetin Alfa
Renal Insufficiency
Urologic Diseases
Hematologic Diseases
Renal Insufficiency, Chronic

Anemia
Kidney Failure, Chronic
Kidney Diseases
Kidney Failure

ClinicalTrials.gov processed this record on January 14, 2009