| Trial ID: | L0705 |
| Source ID: | NCT06288451
|
| Associated Drug: |
Oral Calcitriol With Cinacalcet Rescue
|
| Title: |
DePTH: De-emphasize PTH
|
| Acronym: |
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Kidney Failure, Chronic|Chronic Kidney Disease-Mineral and Bone Disorder
|
| Interventions: |
DRUG: Oral calcitriol with cinacalcet rescue|DRUG: IV activated vitamin D
|
| Outcome Measures: |
Primary: Change in fibroblast growth factor-23, Change in fibroblast growth factor-23, 12 months | Secondary: Change in serum calcium, Change in serum calcium, 12 months|Change in serum phosphate, Change in serum phosphate, 12 months|Change in serum bone-specific alkaline phosphatase, Change in serum bone-specific alkaline phosphatase, 12 months|Change in serum parathyroid hormone, Change in serum parathyroid hormone, 12 months|Change in T50 test of serum calcification propensity, Change in T50 test of serum calcification propensity, 12 months | Other: Patient acceptability, Study acceptability to patients rated from 1 to 5 with 1 being the lowest acceptability and 5 being the highest, 6 months|Patient acceptability, Study acceptability to patients rated from 1 to 5 with 1 being the lowest acceptability and 5 being the highest, 12 months
|
| Sponsor/Collaborators: |
Sponsor: University of Washington | Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
90
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2024-03-11
|
| Completion Date: |
2027-02-28
|
| Results First Posted: |
|
| Last Update Posted: |
2024-06-14
|
| Locations: |
University of Washington, Seattle, Washington, 98104, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT06288451
|
