drugset / Trial / NCT06288451
DePTH: De-emphasize PTH
Phase 2
Active not recruiting
90 enrolled
University of Washington
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · collab
RandomizedParallel-groupSingle-blindTreatment
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).
Timeline
- Start
- 2024-03-11
- Primary completion
- 2027-02-28
- Completion
- 2027-02-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Calcitriol | Small molecule | 0.5 ug | — |
| Background | Cinacalcet | Other / unclassified | 30 mg | — |