NCT06288451Active, not recruitingPhase 2
DePTH: De-emphasize PTH
DePTH: De-emphasize Parathyroid Hormone
Source: ClinicalTrials.gov · Last updated 2 Jun 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 23 Feb 2024
- Start date
- 11 Mar 2024
- Primary completion date
- 28 Feb 2027
- Lead sponsor
- University of Washington
- Diseases
- Chronic kidney disease
- NCT number
- NCT06288451
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 90
- From 11 Mar 2024 to the primary completion date, 28 Feb 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of parathyroidectomy or calciphylaxis
Lab values
- Calcium \>9.8 mg/dL
- Phosphate \>9 mg/dL
Other
- Severe secondary hyperparathyroidism (PTH \>=600 pg/mL x 2 consecutive measures at least 1 month apart despite paricalcitol \>=10 mcg 3x/week or doxercalciferol \>=5 mcg 3x/week or cinacalcet \>30 mg/d)
- Cholestyramine, phenytoin/phenobarbital, or ketoconazole use
- Breast-feeding mothers
- Inability to provide informed consent and no legally authorized representative
Who the study is looking for
- Age \>=18 years
- Kidney failure treated with in-center hemodialysis
- PTH \>=150 pg/mL x 2 consecutive measures at least 1 month apart or active IV activated vitamin D treatment using the NKC protocol
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Washington Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.