Clinical trial
DePTH: De-emphasize Parathyroid Hormone
Name
STUDY00018021
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).
Trial arms
Trial start
2024-03-11
Estimated PCD
2027-02-28
Trial end
2027-02-28
Status
Recruiting
Phase
Early phase I
Treatment
Oral calcitriol with cinacalcet rescue
Participants will receive in-center oral calcitriol at a fixed dose of 0.5 mcg three times weekly at their dialysis treatment sessions regardless of their parathyroid hormone (PTH) concentrations over the 12-month trial period. Only if their serum PTH exceeds 800 pg/mL over 2 consecutive measurements will they be started on cinacalcet at 30 mg/d in order to protect against severe unremitting hyperparathyroidism.
Arms:
Low dose oral calcitriol
IV activated vitamin D
Participants will continue to receive intravenously-administered activated vitamin D per the Northwest Kidney Center treatment protocol, dose-titrated to monthly to quarterly parathyroid hormone concentrations.
Arms:
Usual care
Size
90
Primary endpoint
Change in fibroblast growth factor-23
12 months
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 90, 'type': 'ESTIMATED'}}
Updated at
2024-03-18
1 organization
2 products
3 indications
Organization
University of WashingtonIndication
Kidney FailureIndication
ChronicProduct
Activated Vitamin D