DePTH: De-emphasize PTH

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

March 11, 2024

Primary Completion Date

February 28, 2027

Study Completion Date

February 28, 2027

Conditions
Kidney Failure, ChronicChronic Kidney Disease-Mineral and Bone Disorder
Interventions
DRUG

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.

DRUG

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.

Trial Locations (1)

98104

University of Washington, Seattle

All Listed Sponsors
collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

lead

University of Washington

OTHER

NCT06288451 - DePTH: De-emphasize PTH | Biotech Hunter | Biotech Hunter