Status:
TERMINATED
Effects of Ergocalciferol on Erythropoetin Stimulating Agent Dose
Lead Sponsor:
Kaiser Permanente
Conditions:
Chronic Kidney Disease Stages 3-5
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Hypothesis: The supplementation of Ergocalciferol (Vitamin D2) to those with Vitamin D deficiency in the Chronic Kidney Disease population requiring recombinant human erythropoietin for the treatment ...
Eligibility Criteria
Inclusion
- Chronic kidney disease
- Age: \>18yo
- Stable Hemoglobin (Hgb) for 1 month on stable dose of erythropoietin for 1 month (defined as erythropoietin dose within 15% of previous months erythropoietin dose)
- Unchanged maintenance oral or intravenous (IV) iron therapy for 1 month
- Serum 25-hydroxy Vitamin D levels \< 30 ng/mL
- History of 25-hydroxy Vitamin D levels \< 30 ng/mL currently on ergocalciferol replacement
Exclusion
- On hemodialysis
- Chronic kidney disease 5
- Hypercalcemic (Calcium level \> 11mg/dL)
- Pregnant female
- Iron deficient (iron saturation \< 20%, Ferritin \< 100ng/mL)
- Presence of active malignancy
- Presence of active infections
- Presence of active inflammatory properties
- Presence of blood dyscrasias
- Active bleeding or bleeding within the past 3 months (other than menses)
- B12 deficiency
- Folate deficiency
- Blood transfusion during participation
- Parathyroid levels exceeding the expected levels allowed for the stage of a subjects Chronic kidney disease (Target Parathyroid in: Chronic kidney disease 3 35-70 pg/mL, Chronic kidney disease 4 70-110 pg/mL)
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01263028
Start Date
August 1 2010
End Date
September 1 2011
Last Update
March 30 2015
Active Locations (1)
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1
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States, 90027