ACTIVE_NOT_RECRUITING

DePTH: De-emphasize PTH

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

DePTH: De-emphasize Parathyroid Hormone

Quick Facts

Study Start:2024-03-11

Study Completion:2027-02-28

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06288451

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Principal Investigator

Simon Hsu, MD, MS

PRINCIPAL_INVESTIGATOR

University of Washington

Study Locations (Sites)

University of Washington

Seattle, Washington, 98104

United States

Collaborators and Investigators

Sponsor: University of Washington

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-11

Study Completion Date2027-02-28

Study Record Updates

Study Start Date2024-03-11

Study Completion Date2027-02-28

Terms related to this study

Additional Relevant MeSH Terms

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