Effects of Ergocalciferol on Erythropoetin Stimulating Agent Dose (EASY)

Kaiser Permanente

Status

Terminated

Conditions

Chronic Kidney Disease Stages 3-5

Treatments

Drug: Ergocalciferol supplementation

Study type

Interventional

Funder types

Other

Identifiers

NCT01263028

SIM2010001

Details and patient eligibility

About

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.

Enrollment

6 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)