DePTH: De-emphasize PTH

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).

Conditions

Kidney Failure, Chronic, Chronic Kidney Disease-Mineral and Bone Disorder

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Study Overview

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Study Details

Study overview

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).

DePTH: De-emphasize Parathyroid Hormone

DePTH: De-emphasize PTH

Condition
Kidney Failure, Chronic
Intervention / Treatment

-

Contacts and Locations

Seattle

University of Washington, Seattle, Washington, United States, 98104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Washington,

Simon Hsu, MD, MS, PRINCIPAL_INVESTIGATOR, University of Washington

Study Record Dates

2027-02-28