Effects of Ergocalciferol on Erythropoetin Stimulating Agent Dose
Stopped early · Not applicable
Conditions studied: Chronic Kidney Disease Stages 3-5
In brief
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 of anemia related to kidney disease will reduce the dose of erythropoietin required to maintain a nonanemic state.
Key facts
- Study ID
- NCT01263028
- Run by
- Kaiser Permanente
- People needed
- 6
- Starts
- 2010-08-01
- Expected to finish
- 2011-09-01
- Last updated by the study team
- 2015-03-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- Kaiser Permanente Los Angeles Medical Center — Los Angeles, California, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.