Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06288451
Status:
RECRUITING
Last Update Posted:
2024-06-14
First Post:
2024-02-23
Brief Title:
DePTH De-emphasize PTH
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
DePTH De-emphasize Parathyroid Hormone
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The De-emphasize Parathyroid Hormone DePTH Study is a 12-month pragmatic randomized parallel-group active comparator open-label blinded end-point study of 90 patients with incident or prevalent secondary hyperparathyroidism and kidney failure treated with in-center hemodialysis It tests the hypothesis that low fixed-dose oral calcitriol intervention will have more favorable effects on a comprehensive panel of biomarkers that assesses mineral metabolism bone turnover and serum calcification propensity compared with variably-dosed intravenous activated vitamin D titrated to PTH targets usual care
Detailed Description:
Because of the kidneys major role in vitamin D metabolism most patients with kidney failure on dialysis have biochemical abnormalities that include vitamin D deficiency and high levels of phosphate fibroblast growth factor-23 FGF-23 and parathyroid hormone PTH All of these abnormalities are associated with cardiovascular disease bone disease and death and are major reasons why nephrologists have treated patients on dialysis with activated vitamin D agents for over 30 years Current guidelines however encourage nephrologists to use high doses of vitamin D in order to lower PTH levels to pre-specified treatment targets This approach to treatment has not been proven to improve health and survival and may be associated with several harms including further increasing levels of FGF-23 a major cardiovascular risk factor increasing calcium levels which may promote vascular calcification low turnover bone disease and interruptions in vitamin D treatments
Administering a low stable dose of vitamin D may be safer and more effective than the current standard of care The De-emphasize PTH DePTH Study is a pragmatic randomized clinical trial of 90 patients on hemodialysis in Seattle WA USA that tests whether a low fixed-dose of oral calcitriol the active form of vitamin D study intervention is more safe effective and feasible compared with the current usual care Participants will be recruited at their hemodialysis treatment centers and randomized in a 11 ratio to one of these two treatment strategies and followed over 12 months Participants randomized to the study intervention will receive a fixed dose of calcitriol 05 mcg three times a week at their dialysis treatment sessions regardless of PTH level over the ensuing 12 months Participants randomized to usual care will maintain the existing approach to treating abnormal mineral metabolism using vitamin D doses titrated to monthly to quarterly measurements of PTH The outcomes for this trial are a panel of blood-based measurements of bone and vascular health that will be drawn at the same time as the blood work done monthly as part of routine dialysis care
Administering a low stable dose of vitamin D may be safer and more effective than the current standard of care The De-emphasize PTH DePTH Study is a pragmatic randomized clinical trial of 90 patients on hemodialysis in Seattle WA USA that tests whether a low fixed-dose of oral calcitriol the active form of vitamin D study intervention is more safe effective and feasible compared with the current usual care Participants will be recruited at their hemodialysis treatment centers and randomized in a 11 ratio to one of these two treatment strategies and followed over 12 months Participants randomized to the study intervention will receive a fixed dose of calcitriol 05 mcg three times a week at their dialysis treatment sessions regardless of PTH level over the ensuing 12 months Participants randomized to usual care will maintain the existing approach to treating abnormal mineral metabolism using vitamin D doses titrated to monthly to quarterly measurements of PTH The outcomes for this trial are a panel of blood-based measurements of bone and vascular health that will be drawn at the same time as the blood work done monthly as part of routine dialysis care
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1K23DK136930-01 | NIH | None | httpsreporternihgovquickSearch1K23DK136930-01 |