Effects of Ergocalciferol on Erythropoetin Stimulating Agent Dose

• Status: Terminated
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

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 of anemia related to kidney disease will reduce the dose of erythropoietin required to maintain a nonanemic state.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kaiser Permanente
• Treatments: Epoetin Alfa; Ergocalciferols; Vitamin D

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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)