CompletedPhase 2

PTH-independent Effects of Encaleret

United States13 participantsStarted 2023-09-01

Plain-language 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 or 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 one (1) week after leaving the clinic. They will have three (3) follow-up phone calls.

Who can participate

Age range18 Years – 100 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Be able to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures.
✓. Age \>= 18 years
✓. Postmenopausal women are allowed to participate in this study:
✓. Body mass index (BMI) \>= 18.5 to \< 39 kg/m\^2
✓. Have a diagnosis of PSH, either permanent PSH (Cohort 1, surgery \>= 12 months ago) or recent PSH (Cohort 2, surgery \< 12 months ago).
✓. Participants must have achieved an albumin-corrected blood calcium level of 7.8-10.2 mg/dL on conventional therapy without significant symptoms of hypocalcemia or hypercalcemia.
✓. Participants being treated with thiazide diuretics may be enrolled if they are willing and able to discontinue thiazides for at least 5 half-lives prior to initiation of encaleret and remain off during the study treatment period. (5 half-lives of hydrochlorothiazide = 75 hours; chlorothiazide = 10 hours; chlorthalidone = 12.5 days). If the thiazide is being used as an antihypertensive, as opposed to use as a urine calcium-lowering drug, alternative therapy will be offered.
✓. Participants being treated with strong CYP3A4 inhibitors (including clarithromycin, telithromycin, nefazodone, itraconazole, ketoconazole, atazanavir, darunavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir, tipranavir) may be enrolled if they are willing and able to discontinue these medications for at least 5 half-lives prior to initiation of encaleret and remain off during the study treatment period.

What they're measuring

Percent Change in Fractional Excretion of Calcium (FECa)

Timeframe: Last measurement (12 hours after last dose of encaleret), baseline (24 hours before first dose of encaleret)

Trial details

NCT IDNCT05735015

SponsorNational Institute of Dental and Craniofacial Research (NIDCR)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2025-05-21

Results submitted2026-02-24

View on ClinicalTrials.gov More Post-Surgical Hypoparathyroidism trials

Plain-language summary

Who can participate

Age range18 Years – 100 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Be able to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures.
✓. Age \>= 18 years
✓. Postmenopausal women are allowed to participate in this study:
✓. Body mass index (BMI) \>= 18.5 to \< 39 kg/m\^2
✓. Have a diagnosis of PSH, either permanent PSH (Cohort 1, surgery \>= 12 months ago) or recent PSH (Cohort 2, surgery \< 12 months ago).
✓. Participants must have achieved an albumin-corrected blood calcium level of 7.8-10.2 mg/dL on conventional therapy without significant symptoms of hypocalcemia or hypercalcemia.
✓. Participants being treated with thiazide diuretics may be enrolled if they are willing and able to discontinue thiazides for at least 5 half-lives prior to initiation of encaleret and remain off during the study treatment period. (5 half-lives of hydrochlorothiazide = 75 hours; chlorothiazide = 10 hours; chlorthalidone = 12.5 days). If the thiazide is being used as an antihypertensive, as opposed to use as a urine calcium-lowering drug, alternative therapy will be offered.
✓. Participants being treated with strong CYP3A4 inhibitors (including clarithromycin, telithromycin, nefazodone, itraconazole, ketoconazole, atazanavir, darunavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir, tipranavir) may be enrolled if they are willing and able to discontinue these medications for at least 5 half-lives prior to initiation of encaleret and remain off during the study treatment period.

PTH-independent Effects of Encaleret

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

PTH-independent Effects of Encaleret

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Exclusion criteria