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Effects of Ergocalciferol on Erythropoetin Stimulating Agent Dose (EASY)

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ClinicalTrials.gov Identifier: NCT01263028
Recruitment Status : Terminated (Strong enrollment efforts resulted in few eligible subjects and high screen failures due to CKD patients with higher vitamin D levels than anticipated.)
First Posted : December 20, 2010
Results First Posted : September 20, 2012
Last Update Posted : March 30, 2015
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Chronic Kidney Disease Stages 3-5 Drug: Ergocalciferol supplementation

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Ergocalciferol on Erythropoetin Stimulating Agent Dose
Study Start Date : August 2010
Primary Completion Date : September 2011
Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.



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

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


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01263028


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

Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT01263028     History of Changes
Other Study ID Numbers: SIM2010001
First Posted: December 20, 2010    Key Record Dates
Results First Posted: September 20, 2012
Last Update Posted: March 30, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Ergocalciferols
Vitamin D
Epoetin Alfa
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Hematinics