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Effects of Ergocalciferol on Erythropoetin Stimulating Agent Dose

Information source: Kaiser Permanente
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Kidney Disease Stages 3-5

Intervention: Ergocalciferol supplementation (Drug)

Phase: N/A

Status: Terminated

Sponsored by: Kaiser Permanente

Official(s) and/or principal investigator(s):
John J Sim, MD, Principal Investigator, Affiliation: Kaiser Permanente

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.

Clinical Details

Official title: Effects of Ergocalciferol on Erythropoetin Stimulating Agent Dose

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Secondary outcome:

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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)

Locations and Contacts

Kaiser Permanente Los Angeles Medical Center, Los Angeles, California 90027, United States
Additional Information

Starting date: August 2010
Last updated: March 10, 2015

Page last updated: August 23, 2015

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