Effects of Ergocalciferol on Erythropoetin Stimulating Agent Dose

Not Applicable

Terminated

• Conditions: Chronic Kidney Disease Stages 3-5
• Interventions: Drug: Ergocalciferol supplementation

• Registration Number: NCT01263028
• Lead Sponsor: Kaiser Permanente

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-12-16
• Study First Submitted QC: 2010-12-16
• Study First Posted: 2010-12-20
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Results First Submitted: 2012-08-21
• Results First Submitted QC: 2012-08-21
• Results First Posted: 2012-09-20
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-10
• Last Update Posted: 2015-03-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ergocalciferol supplementation	Ergocalciferol supplementation	-

Primary Outcome Measures

Name	Time	Method
Evaluate if Ergocalciferol Supplementation to Achieve 25-hydroxy Vitamin D Levels > 40ng/ml Will Decrease Erythropoietin Requirements	24 Weeks

Secondary Outcome Measures

Name	Time	Method
Change in Inflammatory Markers	24 Weeks
Change in Calcium, Phosphorous,Calcium x Phosphorous Product, and Parathyroid Hormone Levels	24 Weeks
Change in Iron Supplementation	24 Weeks
Change in Erythropoietin Adjusted for Change in Inflammatory Markers, Vitamin D Levels and Clinical and Demographic Confounders	24 Weeks

Trial Locations

Locations (1)

Kaiser Permanente Los Angeles Medical Center; 🇺🇸 Los Angeles, California, United States