Clinical trial NCT01395823: Safety and Effects of Supplementation With Ergocalciferol on Erythropoietin Dosing in Hemodialysis Patients
Official title: Safety and Effects of Supplementation With Ergocalciferol on Erythropoietin Dosing in Hemodialysis Patients: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: End Stage Renal Disease
Lead sponsor: Dialysis Clinic, Inc.
Sponsor class: INDUSTRY
First posted: 2011-07-18
Enrollment: 470
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A few studies have reported erythropoiesis-stimulating agent (ESA) doses before and after 25D supplementation, but only one of these is a prospective clinical trial, and it is a small, single center study lacking a control arm. The investigators propose to conduct a double blind, randomized, placebo controlled clinical trial of ergocalciferol supplementation to confirm safety and determine effects on Erythropoietin (EPO) dosing, active D dosing, and mineral metabolic parameters in hemodialysis patients.


Eligibility criteria: Inclusion Criteria:

1. Patients treated with thrice weekly in-center hemodialysis (HD) for more than 90 days.
2. Treated with EPO for at least 90 days. The mode of administration, intravenous (IV) or subcutaneous (SC), must remain the same for 90 days prior to enrollment.
3. The method by which EPO is prescribed (per DCI Corporate or local protocol or per physician on an individualized basis) must remain the same for at least 90 days prior to enrollment with respect to the ceiling for the total EPO dose administered per week, if a ceiling is used, and the level of hemoglobin (Hgb) at which EPO is discontinued (Hgb cutoff), if a Hgb cutoff is used.
4. The method by which IV Iron is prescribed (per DCI Corporate or local protocol or per physician on an individualized basis) must remain the same for at least 90 days prior to enrollment with respect to the serum ferritin and transferrin saturation (TSAT) targeted, if specific ferritin and TSAT targets are used

Exclusion Criteria:

1. Patients with a serum calcium ≥10.5 mg/dL on at least one occasion in the past 30 days.
2. Patients with a serum phosphorus \>8.0 mg/dL on at least one occasion in the past 30 days.
3. Active infection defined by the use of IV antibiotic use within the past 30 days.
4. Current use of immunosuppressant medications other than low dose corticosteroids (prednisone \<10 mg per day or equivalent)
5. History of a hematological malignancy (e.g. multiple myeloma, leukemia).
6. Sickle cell disease (sickle cell trait is not an exclusion).
7. Myelodysplasia requiring 1 or more blood transfusions in the past 3 months.
8. Transfusion for any reason within the past 30 days.
9. Medical conditions that cause a reduction in the absorption of oral vitamin D including Crohn's disease, celiac sprue, cystic fibrosis and surgical removal of part or all of the stomach or intestine.
10. Medications that cause a reduction in the absorption of oral vitamin D including cholestyramine (Questran, others), colestipol (Colestid, others) and orlistat (Xenical, Alli).
11. Known allergy/adverse reaction to ergocalciferol.
12. Treated with ergocalciferol and/or cholecalciferol (except if part of a multi-vitamin) within the last 3 months.
13. Average Kt/V \< 1.3 on past three monthly labs. There must be at least 2 monthly Kt/V values in the past three months.
14. Skipped more than 3 dialysis treatments (excluding planned missed treatments) within the past 3 months for reasons other than hospitalization.
15. Life expectancy less than 6 months.
16. Kidney transplantation planned in the next 6 months.
17. Switch to peritoneal dialysis planned in the next 6 months.
18. Pregnant or planning to become pregnant within the next 6 months. A pre-menopausal woman must agree to use contraception for the duration of the study. If a woman has not had menses in over 12 months, consider this patient to be menopausal.
19. Unable or unwilling to give informed consent.

Primary outcomes:
measure: EPO Dose
timeFrame: Baseline, 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Redding
country: United States
facility: DCI - Redding
state: California
city: Albany
country: United States
facility: DCI - Albany
state: Georgia
city: Shreveport
country: United States
facility: DCI - Shreveport
state: Louisiana
city: Boston
country: United States
facility: DCI - Boston
state: Massachusetts
city: Columbia
country: United States
facility: DCI- Columbia
state: Missouri
city: Kansas City
country: United States
facility: DCI - Kansas City
state: Missouri
city: Omaha
country: United States
facility: DCI- Omaha
state: Nebraska
city: New Brunswick
country: United States
facility: DCI - New Brunswick
state: New Jersey
city: North Brunswick
country: United States
facility: DCI - North Brunswick
state: New Jersey
city: Philadelphia
country: United States
facility: DCI - Philadelphia
state: Pennsylvania
city: Knoxville
country: United States
facility: DCI - Knoxville
state: Tennessee
city: Maryville
country: United States
facility: DCI - Maryville
state: Tennessee
Study officials:
affiliation: DCI
name: Dana Miskulin, MD
role: PRINCIPAL_INVESTIGATOR
References: