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Effects of Ergocalciferol on Erythropoetin Stimulating Agent Dose (EASY)

This study has been terminated.
(Strong enrollment efforts resulted in few eligible subjects and high screen failures due to CKD patients with higher vitamin D levels than anticipated.)
Information provided by (Responsible Party):
Kaiser Permanente Identifier:
First received: December 16, 2010
Last updated: March 10, 2015
Last verified: March 2015
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.

Condition Intervention
Chronic Kidney Disease Stages 3-5 Drug: Ergocalciferol supplementation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Ergocalciferol on Erythropoetin Stimulating Agent Dose

Resource links provided by NLM:

Further study details as provided by Kaiser Permanente:

Primary Outcome Measures:
  • Evaluate if Ergocalciferol Supplementation to Achieve 25-hydroxy Vitamin D Levels > 40ng/ml Will Decrease Erythropoietin Requirements [ Time Frame: 24 Weeks ]

Secondary Outcome Measures:
  • Change in Inflammatory Markers [ Time Frame: 24 Weeks ]
  • Change in Calcium, Phosphorous,Calcium x Phosphorous Product, and Parathyroid Hormone Levels [ Time Frame: 24 Weeks ]
  • Change in Iron Supplementation [ Time Frame: 24 Weeks ]
  • Change in Erythropoietin Adjusted for Change in Inflammatory Markers, Vitamin D Levels and Clinical and Demographic Confounders [ Time Frame: 24 Weeks ]

Enrollment: 6
Study Start Date: August 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ergocalciferol supplementation 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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)
  Contacts and Locations
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Please refer to this study by its identifier: NCT01263028

United States, California
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States, 90027
Sponsors and Collaborators
Kaiser Permanente
Principal Investigator: John J Sim, MD Kaiser Permanente
  More Information

Responsible Party: Kaiser Permanente Identifier: NCT01263028     History of Changes
Other Study ID Numbers: SIM2010001
Study First Received: December 16, 2010
Results First Received: August 21, 2012
Last Updated: March 10, 2015

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Vitamin D
Epoetin Alfa
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Hematinics processed this record on July 25, 2017