Chronic Kidney Disease Stages 3-5
Conditions
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.
Interventions
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.
Sponsors
Kaiser Permanente
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate if Ergocalciferol Supplementation to Achieve 25-hydroxy Vitamin D Levels > 40ng/ml Will Decrease Erythropoietin Requirements | 24 Weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Participant flow
Recruitment details
Recruitment began in February 2011 at Kaiser Permanente Los Angeles Medical Center. Despite strong enrollment efforts only 6 particiants were enrolled out of 10 screened.
Pre-assignment details
Participants were assessed for study inclusion based on chronic kidney disease (CKD) stage, age, current vitamin D levels \<30 ng/ml as well as history of vitamin D levels \< 30, and stable dose of erythropoietin and iron.
Participants by arm
| Arm | Count |
|---|---|
| Ergocalciferol Supplementation | 6 |
| Total | 6 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Study terminated due to low enrollment. | 4 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Ergocalciferol Supplementation |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 5 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Region of Enrollment United States | 6 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 6 |
| serious Total, serious adverse events | 0 / 6 |
Outcome results
Primary
Evaluate if Ergocalciferol Supplementation to Achieve 25-hydroxy Vitamin D Levels > 40ng/ml Will Decrease Erythropoietin Requirements
Time frame: 24 Weeks
Secondary
Change in Calcium, Phosphorous,Calcium x Phosphorous Product, and Parathyroid Hormone Levels
Time frame: 24 Weeks
Secondary
Change in Erythropoietin Adjusted for Change in Inflammatory Markers, Vitamin D Levels and Clinical and Demographic Confounders
Time frame: 24 Weeks
Secondary
Change in Inflammatory Markers
Time frame: 24 Weeks
Secondary
Change in Iron Supplementation
Time frame: 24 Weeks