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Terminated/Withdrawn
Sponsor ID
20050122

STIMULATE Study: Anemia Correction and Health-related Quality of Life (HRQoL) Outcomes in Elderly Chronic Kidney Disease (CKD) patients

Sponsor ID
20050122
Clinicaltrials.gov ID
NCT00364845
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

Treatment of anemia associated with chronic kidney disease (CKD) during 36 weeks with safety follow up phase of 52 weeks

Additional Study Details

Phase
Phase 3
Product
darbepoetin alfa
Type
Interventional
Masking
Single (Participant)
Enrollment
51
Additional Study Details

Protocol Summary

Primary Outcome Measures

SF-36 Vitality Subscale Score

Timeframe: Week 24

Secondary Outcome Measures

Proportion of Participants With Hemoglobin (Hb) ≥ 110 grams per litre (g/L)

Timeframe: Evaluation Period (Weeks 22-36)

Mean Hb

Timeframe: Evaluation Period (Weeks 22-36)

EQ-5D Utility Score

Timeframe: Week 24

Study Documents

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

Locations

No locations found.
Study Info
Age
70+ years
Condition
  • Anemia
  • Kidney Disease
    • Sex
    All
    Trial Dates
    Sep 2006 - Dec 2008
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - Stage 3-5 CKD not on dialysis - Patients ≥ 70 years of age - Haemoglobin < 110g/L at screening - Transferrin saturation ≥ 15% at screening
    Exclusion Criteria:
    - Clinical history of type 2 diabetes mellitus - Anticipating or scheduled to go on renal replacement therapy in the next year, including renal transplant - Uncontrolled hypertension on two separate measurements during screening - Use of any erythropoietic protein within 12 weeks of screening