Status:
TERMINATED
STIMULATE Study: Anemia Correction and Health-related Quality of Life (HRQoL) Outcomes in Elderly Chronic Kidney Disease (CKD) Patients
Lead Sponsor:
Amgen
Conditions:
Anemia
Chronic Kidney Disease
Eligibility:
All Genders
70+ years
Phase:
PHASE3
Brief Summary
Treatment of anemia associated with chronic kidney disease (CKD) during 36 weeks with safety follow up phase of 52 weeks
Detailed Description
This is a multicentre, randomised, single-blind, placebo-controlled, two-arm parallel group study assessing the effect of anaemia correction and Hb maintenance with darbepoetin alfa in elderly CKD pat...
Eligibility Criteria
Inclusion
- Stage 3-5 CKD not on dialysis
- Patients ≥ 70 years of age
- Haemoglobin \< 110g/L at screening
- Transferrin saturation ≥ 15% at screening
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT00364845
Start Date
September 1 2006
End Date
February 1 2009
Last Update
May 21 2014
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