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Study Complete
Sponsor ID
20060163

Evaluation of Monthly Darbepoetin Alfa Dosing for Correction of Anemia in non-dialysis Chronic Kidney Disease

Sponsor ID
20060163
Clinicaltrials.gov ID
NCT00925587
EUCTIS ID
N/A
EudraCT ID
2006-003173-27
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Study Details

The purpose of this study is to determine whether once monthly (QM) dosing of darbepoetin alfa is non-inferior to that of once every 2 week (Q2W) dosing of darbepoetin alfa for the correction of anemia in patients with Chronic Kidney Disease who are not receiving dialysis.

Additional Study Details

Phase
Phase 3
Product
darbepoetin alfa
Type
Interventional
Masking
Double (Participant, Investigator)
Enrollment
358
Additional Study Details

Protocol Summary

Primary Outcome Measures

Hb change between baseline and the evaluation period (weeks 29-33)

Timeframe: Baseline to Week 33 (end of study)

Secondary Outcome Measures

Achievement of both a Hb >= 10.0 g/dL and a >= 1.0 g/dL increase from baseline at any time point following de novo darbepoetin alfa administration.

Timeframe: Baseline to Week 33 (end of study)

Darbepoetin alfa doses over duration of study

Timeframe: Baseline to Week 33 (end of study)

Safety profiles of darbepoetin alfa administered de novo QM and Q2W

Timeframe: Baseline to Week 33 (end of study)

Hb at each scheduled time point during the study

Timeframe: Baseline to week 33 (end of study)

Ratio of darbepoetin alfa doses over the duration of the study and during the evaluation period (Weeks 29-33) to the darbepoetin alfa dose at baseline

Timeframe: Baseline to Week 33 (end of study)

Dose at first Hb >= 10.0 g/dL and a >= 1.0 g/dL increase from baseline

Timeframe: Baseline to Week 33 (end of study)

Time to first Hb >= 10.0 g/dL and a >= 1.0 g/dL increase from baseline

Timeframe: Baseline to Week 33 (end of study)

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

Location
Status
Contact Us
Location
Research Site
New Lambton, NSW, Australia, 2305
Status
Recruiting
Location
Research Site
Gosford, NSW, Australia, 2250
Status
Recruiting
Location
Research Site
Parkville, VIC, Australia, 3050
Status
Completed
Location
Research Site
Reservoir, VIC, Australia, 3073
Status
Recruiting
Location
Research Site
Box Hill, VIC, Australia, 3128
Status
Recruiting
Location
Research Site
Randwick, NSW, Australia, 2031
Status
Recruiting
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Study Info
Age
18+ years
Condition
  • Anemia
  • Kidney Disease
    • Sex
    All
    Trial Dates
    Jun 2009 - Apr 2012
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - ≥ 18 years of age - Diagnosis of chronic kidney disease with eGFR of 15-59 mL/min/1.73 m2 (MDRD equation) - Two consecutive screening Hb values taken at least 7 days apart must each be <10.0 g/dL - TSAT ≥ 15%
    Exclusion Criteria:
    - Upper or lower GI bleeding within 6 months before enrolment - ESA use within 12 weeks before enrolment - Uncontrolled hypertension - Systemic haematologic disorders - Prior history within 12 weeks before enrollment of events including: Acute myocardial ischemia, unstable angina, myocardial infarction, hospitalization for congestive heart failure, stroke or transient ischaemic attack, limb ischaemia, deep vein thrombosis, thromboembolism. - Grand mal seizure within 6 months prior to enrolment - Evidence of, or received chemotherapy or radiation therapy for, a malignancy within 5 years prior to enrolment. - Red blood cell transfusion within 12 weeks prior to enrolment - Androgen therapy within 8 weeks prior to enrolment - Pregnancy or breast feeding, or inadequate contraception - Currently receiving immunosuppressive therapy