Active — Not RecruitingPhase 2

DePTH: De-emphasize PTH

United States90 participantsStarted 2024-03-11

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. History of parathyroidectomy or calciphylaxis
✕. 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)
✕. Calcium \>9.8 mg/dL
✕. Phosphate \>9 mg/dL
✕. Cholestyramine, phenytoin/phenobarbital, or ketoconazole use
✕. Breast-feeding mothers
✕. Inability to provide informed consent and no legally authorized representative

What they're measuring

Change in fibroblast growth factor-23

Timeframe: 12 months

Trial details

NCT IDNCT06288451

SponsorUniversity of Washington

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-02-28

View on ClinicalTrials.gov More Kidney Failure, Chronic trials