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Calcium-Sensing Receptor Antagonist
Encaleret for Hypoparathyroidism
Phase 2
Recruiting
Led By Michael T Collins, M.D.
Research Sponsored by National Institute of Dental and Craniofacial Research (NIDCR)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 days
Awards & highlights
Study Summary
This trial is testing a drug to help keep stable blood calcium levels in people with postsurgical hypoparathyroidism. Participants will have exams, tests, and take the study drug.
Who is the study for?
Adults with postsurgical hypoparathyroidism (PSH) can join this study. They must have stable blood calcium levels on current treatments, a BMI between 18.5 and <39 kg/m2, and normal or managed thyroid function. Pregnant women, those at childbearing age not using contraception, people with recent substance dependency, certain heart conditions, liver issues or severe kidney problems cannot participate.Check my eligibility
What is being tested?
The trial is testing encaleret for PSH patients to manage their blood calcium without causing kidney issues. Participants will take encaleret orally twice daily for five days during a week-long clinic stay where they'll undergo frequent blood tests and urine collection followed by follow-up checks.See study design
What are the potential side effects?
While specific side effects of encaleret are not listed here, common side effects in trials may include digestive discomfort, potential allergic reactions to the drug's components, changes in mineral levels that could affect bone health or organ function.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Effect of encaleret on Fractional Excretion of Calcium
Secondary outcome measures
Effect of encaleret on achieving concomitant normal fasting blood calcium and a normal 24-hour urinary calcium level
Trial Design
1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment1 Intervention
All participants given 5 days of encaleret twice daily
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Who is running the clinical trial?
National Institute of Dental and Craniofacial Research (NIDCR)Lead Sponsor
300 Previous Clinical Trials
848,314 Total Patients Enrolled
2 Trials studying Hypoparathyroidism
66 Patients Enrolled for Hypoparathyroidism
Michael T Collins, M.D.Principal InvestigatorNational Institute of Dental and Craniofacial Research (NIDCR)
2 Previous Clinical Trials
81 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My liver isn't working well.I have had a seizure caused by low calcium in the last 3 months.I have a serious heart condition.I have been treated with encaleret before.I can stop taking strong CYP3A4 inhibitors before starting the study treatment.I have been diagnosed with PSH and had surgery either more or less than a year ago.I am 18 years old or older.My hemoglobin level is below the normal range for my gender.I am using specific birth control methods as a sexually active male.My corrected calcium levels are stable with my current treatment.I am a postmenopausal woman meeting specific criteria.I haven't taken PTH analogs in the last 3 months.I will stop taking magnesium or potassium citrate supplements two days before the trial starts.I am willing to stop taking my water pills before starting the study treatment.I am willing to stop taking my mineral metabolism medication before starting the study treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are geriatric patients able to enroll in this research project?
"The age parameters for this trial are 18 as the lower limit and 100 as the upper threshold."
Answered by AI
Did the Food and Drug Administration grant consent for this medication?
"The safety of this intervention was gauged to be a 2 on the 1-3 scale due to it being in Phase 2 and having evidence stemming from its security, though none for efficacy."
Answered by AI
What is the highest quantity of participants that can be included in this clinical investigation?
"Affirmative. According to the information on clinicaltrials.gov, this medical study is actively recruiting participants. The trial was first posted in July 1st 2023 and subsequently updated 16th June 2023 and it seeks to enlist a total of 20 individuals from one location."
Answered by AI
Are there still opportunities to participate in this research experiment?
"Indeed, the information hosted on clinicaltrials.gov reveals that this trial is open to recruitment. The study was first published in July 1st 2023 and has been updated for the last time on June 16th of the same year. This medical experiment needs a total of 20 volunteers who can be found at one site."
Answered by AI
What are the eligibility requirements for participants of this research?
"People aged 18 and up who suffer from hypoparathyroidism qualify for this trial, which is currently accepting 20 patients."
Answered by AI
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