Effects of Ergocalciferol on Erythropoetin Stimulating Agent Dose

Chronic Kidney Disease Stages 3-5 Clinical Trial

— EASY  

Official title:

Effects of Ergocalciferol on Erythropoetin Stimulating Agent Dose

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01263028
• Other study ID #: SIM2010001
• Status: Terminated
• Phase: N/A
• First received: December 16, 2010
• Last updated: March 10, 2015
• Start date: August 2010
• Est. completion date: September 2011

Study information

• Verified date: March 2015
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease Stages 3-5
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Ergocalciferol supplementation
Vitamin D in the form of ergocalciferol will be the drug utilized in the study. This medication is a Vitamin D analog and is normally used in the current study population to help augment those who are deficient in Vitamin D.

Locations

Country	Name	City	State
United States	Kaiser Permanente Los Angeles Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Kaiser Permanente

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate if Ergocalciferol Supplementation to Achieve 25-hydroxy Vitamin D Levels > 40ng/ml Will Decrease Erythropoietin Requirements		24 Weeks	No
Secondary	Change in Inflammatory Markers		24 Weeks	No
Secondary	Change in Calcium, Phosphorous,Calcium x Phosphorous Product, and Parathyroid Hormone Levels		24 Weeks	No
Secondary	Change in Iron Supplementation		24 Weeks	No
Secondary	Change in Erythropoietin Adjusted for Change in Inflammatory Markers, Vitamin D Levels and Clinical and Demographic Confounders		24 Weeks	No