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Effects of Ergocalciferol on Erythropoetin Stimulating Agent Dose (EASY)

Primary Purpose

Chronic Kidney Disease Stages 3-5

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ergocalciferol supplementation
Sponsored by
Kaiser Permanente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease Stages 3-5

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Kaiser Permanente Los Angeles Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ergocalciferol supplementation

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
December 16, 2010
Last Updated
March 10, 2015
Sponsor
Kaiser Permanente
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1. Study Identification

Unique Protocol Identification Number
NCT01263028
Brief Title
Effects of Ergocalciferol on Erythropoetin Stimulating Agent Dose
Acronym
EASY
Official Title
Effects of Ergocalciferol on Erythropoetin Stimulating Agent Dose
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Terminated
Why Stopped
Strong enrollment efforts resulted in few eligible subjects and high screen failures due to CKD patients with higher vitamin D levels than anticipated.
Study Start Date
August 2010 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease Stages 3-5

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ergocalciferol supplementation
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Ergocalciferol supplementation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evaluate if Ergocalciferol Supplementation to Achieve 25-hydroxy Vitamin D Levels > 40ng/ml Will Decrease Erythropoietin Requirements
Time Frame
24 Weeks
Secondary Outcome Measure Information:
Title
Change in Inflammatory Markers
Time Frame
24 Weeks
Title
Change in Calcium, Phosphorous,Calcium x Phosphorous Product, and Parathyroid Hormone Levels
Time Frame
24 Weeks
Title
Change in Iron Supplementation
Time Frame
24 Weeks
Title
Change in Erythropoietin Adjusted for Change in Inflammatory Markers, Vitamin D Levels and Clinical and Demographic Confounders
Time Frame
24 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John J Sim, MD
Organizational Affiliation
Kaiser Permanente
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaiser Permanente Los Angeles Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States

12. IPD Sharing Statement

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Effects of Ergocalciferol on Erythropoetin Stimulating Agent Dose

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