A Phase 4 interventional study of doxercalciferol in Hyperparathyroidism, Secondary and Kidney Failure, Chronic, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-01-22.
Sponsored by Duke University · Phase 4, Interventional, and Treatment
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.
1,995 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.
This study's enrollment of 24 is below the median of 43 across 1,503 interventional studies indexed under Renal Insufficiency.
Browse Renal Insufficiency studies →Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.
Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
We prospectively enrolled 24 hemodialysis patients with secondary hyperparathyroidism into an open-label 30-day observational study.
| Milestone | Pre Doxercalciferol/Post Doxercalciferol |
|---|---|
| Started | 24 |
| Completed | 20 |
| Not completed | 4 |
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.
| percent change in FMD | Pre-post Comparison |
|---|---|
| Change in Endothelial Cell Function | .23 ± 1.4 |
Non-serious events are listed at a 0.1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pre and Post Doxicalciferol | — | 1/20 (5%) | 1/20 (5%) |
| Event | Pre and Post Doxicalciferol |
|---|---|
| atypical chest painCardiac disorders | 1/20 |
| diabetic gastroparesisMetabolism and nutrition disorders | 1/20 |
| Event | Pre and Post Doxicalciferol |
|---|---|
| serum phosphorus 10.4Metabolism and nutrition disorders | 1/20 |
| Age, Categorical(Participants) | Pre-post Comparison |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 20 |
| >=65 years | 0 |
| Age, Continuous(years) | Pre-post Comparison |
|---|---|
| Mean | 50.4 ± 12.2 |
| Sex: Female, Male(Participants) | Pre-post Comparison |
|---|---|
| Female | 6 |
| Male | 14 |
| Region of Enrollment(participants) | Pre-post Comparison |
|---|---|
| United States | 20 |
This study is completed, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Duke University