Safety and Effects of Supplementation With Ergocalciferol on Erythropoietin Dosing in Hemodialysis Patients

NCT01395823 | Completed Phase 4 Results

• 1 other identifier: DCI-0002
• Study Type: interventional
• Target: 470
• Locations: 1 country
• Sites: 12

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.

Conditions

End Stage Renal Disease

Outcome Measures

Primary Outcomes (1)

• EPO Dose

  The primary outcome is the change in the median EPO dose from baseline to 6 months after ergocalciferol supplementation.

  Baseline, 6 months

Study Arms (2)

ergocalciferol supplementation

OTHER

Dietary Supplement: ergocalciferol supplementation

placebo

PLACEBO COMPARATOR

Other: placebo

Interventions

ergocalciferol supplementation DIETARY_SUPPLEMENT

50,000 IU given either weekly; weekly for 3 months then monthly for 3 months; monthly

Also known as: vitamin D, D2

ergocalciferol supplementation

placebo OTHER

placebo pill given weekly, weekly for 3 months then monthly for 3 months; monthly

Also known as: sugar pill

placebo

Eligibility Criteria

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

You may qualify if:

• Patients treated with thrice weekly in-center hemodialysis (HD) for more than 90 days.
• 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.
• 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.
• 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

You may not qualify if:

• Patients with a serum calcium ≥10.5 mg/dL on at least one occasion in the past 30 days.
• Patients with a serum phosphorus \>8.0 mg/dL on at least one occasion in the past 30 days.
• Active infection defined by the use of IV antibiotic use within the past 30 days.
• Current use of immunosuppressant medications other than low dose corticosteroids (prednisone \<10 mg per day or equivalent)
• History of a hematological malignancy (e.g. multiple myeloma, leukemia).
• Myelodysplasia requiring 1 or more blood transfusions in the past 3 months.
• Transfusion for any reason within the past 30 days.
• 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.
• Medications that cause a reduction in the absorption of oral vitamin D including cholestyramine (Questran, others), colestipol (Colestid, others) and orlistat (Xenical, Alli).
• Known allergy/adverse reaction to ergocalciferol.
• Treated with ergocalciferol and/or cholecalciferol (except if part of a multi-vitamin) within the last 3 months.
• 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.
• Skipped more than 3 dialysis treatments (excluding planned missed treatments) within the past 3 months for reasons other than hospitalization.
• Life expectancy less than 6 months.
• Kidney transplantation planned in the next 6 months.

Sponsors & Collaborators

• Dialysis Clinic, Inc.: lead

Study Sites (12)

DCI - Redding

Redding, California, 96003, United States

Location

DCI - Albany

Albany, Georgia, 31701, United States

Location

DCI - Shreveport

Shreveport, Louisiana, 71103, United States

Location

DCI - Boston

Boston, Massachusetts, 02111, United States

Location

DCI- Columbia

Columbia, Missouri, 65201, United States

Location

DCI - Kansas City

Kansas City, Missouri, 64131, United States

Location

DCI- Omaha

Omaha, Nebraska, 68131, United States

Location

DCI - New Brunswick

New Brunswick, New Jersey, 08903, United States

Location

DCI - North Brunswick

North Brunswick, New Jersey, 08902, United States

Location

DCI - Philadelphia

Philadelphia, Pennsylvania, 19129, United States

Location

DCI - Knoxville

Knoxville, Tennessee, 37924, United States

Location

DCI - Maryville

Maryville, Tennessee, 37804, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Vitamin D; Sugars

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Carbohydrates

Results Point of Contact

• Title: Karen Majchrzak
• Organization: Dialysis Clinic Inc

karen.majchrzak@dciinc.org

615-342-0483

Study Officials

• Dana Miskulin, MD

  DCI

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2011
• First Posted: July 18, 2011
• Study Start: June 1, 2011
• Primary Completion: April 1, 2014
• Study Completion: June 1, 2015
• Last Updated: March 14, 2016
• Results First Posted: March 14, 2016

Record last verified: 2016-02

Locations

US (12)