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.)
Sponsor:
Information provided by (Responsible Party):
John Sim, MD, Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT01263028
First received: December 16, 2010
Last updated: August 21, 2012
Last verified: August 2012
  Purpose

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: Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Inflammatory Markers [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
  • Change in Calcium, Phosphorous,Calcium x Phosphorous Product, and Parathyroid Hormone Levels [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
  • Change in Iron Supplementation [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
  • Change in Erythropoietin Adjusted for Change in Inflammatory Markers, Vitamin D Levels and Clinical and Demographic Confounders [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: John Sim, MD, Physician, Kaiser Permanente
ClinicalTrials.gov Identifier: NCT01263028     History of Changes
Other Study ID Numbers: SIM2010001
Study First Received: December 16, 2010
Results First Received: August 21, 2012
Last Updated: August 21, 2012
Health Authority: United States: Institutional Review Board

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
Pharmacologic Actions
Bone Density Conservation Agents
Hematinics
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014