DePTH: De-emphasize Parathyroid Hormone

Description

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).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 reas

Trial Eligibility

Inclusion Criteria: 1. Age \>=18 years 2. Kidney failure treated with in-center hemodialysis 3. PTH \>=150 pg/mL x 2 consecutive measures at least 1 month apart or active IV activated vitamin D treatment using the NKC protocol Exclusion Criteria: 1. History of parathyroidectomy or calciphylaxis 2. 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) 3. Calcium \>9.8 mg/dL 4. Phosphate \>9 mg/dL 5. Cholestyramine, phenytoin/phenobarbital, or ketoconazole use 6. Breast-feeding mothers 7. Inability to provide informed consent and no legally authorized representative

Study Info

Interventions

Locations Recruiting

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