Hyperparathyroidism, Secondary, Kidney Failure, Chronic
Conditions
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.
Interventions
DRUGdoxercalciferol
Sponsors
Genzyme, a Sanofi Company
Duke University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Stage 5 Chronic Kidney Disease * Hyperparathyroidism (PTH\>300) requiring vitamin D therapy * Age 18-80 years old * Ability to provide informed consent
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Endothelial Cell Function | 1 month | 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. |
Countries
United States
Participant flow
Recruitment details
We prospectively enrolled 24 hemodialysis patients with secondary hyperparathyroidism into an open-label 30-day observational study.
Pre-assignment details
Participants underwent review of history and meds. Hemodialysis (HD) blood was drawn. seen in vascular laboratory for testing of endothelial cell function and arterial stiffness. Doxercalciferol was initiated at dose of 2 mcg IV 3x/wk or 4 mcg IV 3x/wk. After 30 days of medication, repeat blood drawn and repeat testing in vascular laboratory.
Participants by arm
| Arm | Count |
|---|---|
| Pre-post Comparison ESRD: all patients with secondary hyperparathyroidism who are vitamin D naive
doxercalciferol : 2 or 4 mcg | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Pre-post Comparison |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants |
| Age, Continuous | 50.4 years STANDARD_DEVIATION 12.2 |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 20 |
| serious Total, serious adverse events | 1 / 20 |
Outcome results
Primary
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.
Time frame: 1 month
Population: prospective open-label 30-day observational study testing the effects of doxercalciferol on mediated vasodilation (FMD) among 20 dialysis pts with secondary hyperparathyroidism
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pre-post Comparison | Change in Endothelial Cell Function | .23 percent change in FMD | Standard Deviation 1.4 |