Study of the PTH-independent Effects of Encaleret on Mineral Homeostasis in Subjects With Postsurgical Hypoparathyroidism (PSH)

• Status: Recruiting
• Trial end date: 2025-03-01

Summary

Background:

Parathyroid glands in the neck make a hormone that keeps blood calcium levels stable. Sometimes these glands are damaged or removed during neck surgery. This can lead to a condition called postsurgical hypoparathyroidism (PSH). People with PSH have low levels of calcium in their blood. Calcium and vitamin D pills can help them keep their blood calcium levels steady. But this can increase calcium in the urine and result in kidney problems. New treatments for PSH are needed.

Objective:

To test a drug (encaleret) in people with PSH.

Eligibility:

People aged 18 years and older who have PSH.

Design:

Participants will be in the study for 6 months. They will have a screening visit and a treatment visit.

Screening will take up to 2 days. Participants will have a physical exam. They will have blood and urine tests and tests of their heart function. They will have an ultrasound of their kidneys; they will lie on a table for 15 to 30 minutes while a wand is moved over their back.

Treatment will require participants to stay in the clinic for 7 days and 6 nights. They will take the study drug (encaleret) by mouth twice a day for 5 days. They will have a small, flexible tube inserted into a vein; this will remain in place during the visit. Blood samples will be taken through the tube 4 to 9 times each day. Participants urine will be collected.

Participants will have follow-up blood tests 1 week after leaving the clinic. They will have 3 follow-up phone calls.

• Phase: Phase 2

Details

• Lead Sponsor: National Institute of Dental and Craniofacial Research (NIDCR)