How Vitamin D Analogues Affect Endothelial Cells in Patients on Dialysis

NCT00528788 | Completed Phase 4 Results DMC

• 1 other identifier: Pro00001559
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with chronic kidney disease and end stage renal disease have greater cardiovascular risk than the general population. Vitamin D analogues have been shown in observational studies to have mortality benefit for these patients. This study is designed to investigate doxercalciferol's effect on the vasculature (i.e. endothelial cell function) as a possible mechanism to explain the mortality benefit.

Conditions

Hyperparathyroidism, Secondary; Kidney Failure, Chronic

Outcome Measures

Primary Outcomes (1)

• Change in Endothelial Cell Function

  Endothelial cell function was assessed by performing flow mediated vasodilatation testing in a vascular laboratory prior to receiving doxercalciferol (either 2 mcg or 4 mcg 3 times per week at hemodialysis) and then after receiving the drug for 30 days.

  1 month

Study Arms (1)

Pre and post doxicalciferol

EXPERIMENTAL

ESRD: all patients with secondary hyperparathyroidism who are vitamin D naive will receive doxercalciferol 2 mcg or 4 mcg 3 times per week fopr 30 days (1 month). Blood work and vascular laboratory studies will be performed pre and post treatment.

Drug: doxercalciferol

Interventions

doxercalciferol DRUG

Pre and post doxicalciferol

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stage 5 Chronic Kidney Disease
• Hyperparathyroidism (PTH\>300) requiring vitamin D therapy
• Age 18-80 years old
• Ability to provide informed consent

You may not qualify if:

• Subjects with neovascularization present, such as neoplasm, active wounds or significant retinopathy
• Subjects with contraindications or allergy to vitamin D
• Subjects currently on vitamin D therapy or a history of vitamin D therapy in the previous 60 days
• Serum phosphorus \> 6
• Serum calcium \> 10.5
• contraindications to nitroglycerin (such as being on sildenafil)

Sponsors & Collaborators

• Duke University: lead
• Genzyme, a Sanofi Company: collaborator

Study Sites (1)

Duke University Medical Center Dialysis Unit

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Hyperparathyroidism, Secondary; Kidney Failure, Chronic

Interventions

1 alpha-hydroxyergocalciferol

Condition Hierarchy (Ancestors)

Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases; 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

Results Point of Contact

• Title: Jula Inrig, MD
• Organization: Duke University Medical Center

Jula.Inrig@duke.edu

919-660-6882

Study Officials

• Jula Inrig, MD, MHS

  University Texas-Southwestern

  PRINCIPAL INVESTIGATOR

• Lynda Szczech, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2007
• First Posted: September 12, 2007
• Study Start: September 1, 2007
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: January 22, 2016
• Results First Posted: April 14, 2014

Record last verified: 2012-08

Locations

US (1)