Effects of Ergocalciferol on Erythropoetin Stimulating Agent Dose

NCT01263028 | Terminated Results

• 1 other identifier: SIM2010001
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease Stages 3-5

Outcome Measures

Primary Outcomes (1)

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

  24 Weeks

Secondary Outcomes (4)

• Change in Inflammatory Markers

  24 Weeks

• Change in Calcium, Phosphorous,Calcium x Phosphorous Product, and Parathyroid Hormone Levels

  24 Weeks

• Change in Iron Supplementation

  24 Weeks

• Change in Erythropoietin Adjusted for Change in Inflammatory Markers, Vitamin D Levels and Clinical and Demographic Confounders

  24 Weeks

Study Arms (1)

Ergocalciferol supplementation

EXPERIMENTAL

Drug: Ergocalciferol supplementation

Interventions

Ergocalciferol supplementation DRUG

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.

Ergocalciferol supplementation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Kaiser Permanente: lead

Study Sites (1)

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, 90027, United States

Location

Limitations and Caveats

Study terminated due to insufficient enrollment numbers.

Results Point of Contact

• Title: John J. Sim, MD
• Organization: Kaiser Permanente

john.j.sim@kp.org

Study Officials

• John J Sim, MD

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2010
• First Posted: December 20, 2010
• Study Start: August 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: March 30, 2015
• Results First Posted: September 20, 2012

Record last verified: 2015-03

Locations

US (1)