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Encaleret for Hypocalcemia (CALIBRATE Trial)
CALIBRATE Trial Summary
This trial will test how well a new medication works to treat a rare calcium imbalance condition compared to current treatment.
CALIBRATE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowCALIBRATE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.CALIBRATE Trial Design
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Who is running the clinical trial?
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- I am 16-17 years old and my growth plates are closed.I have had surgery on my thyroid or parathyroid.I have shown symptoms or signs of ADH1.My kidney function is low, with an eGFR below 30 mL/min/1.73 m^2.I have had a seizure caused by low calcium in the last 3 months.I have had a kidney transplant.I've used parathyroid hormone treatments recently and need higher doses or have high bone turnover markers.I am willing to stop taking magnesium or potassium supplements before starting encaleret.I am willing to stop taking potassium-sparing diuretics before starting encaleret.I have Hepatitis B, A, or HIV, or I am cured of Hepatitis C.I have stopped taking thiazide diuretics for at least 14 days.I have a genetic variant in the CASR gene linked to low parathyroid hormone levels.I will stop taking phosphate binders one day before my first optimization visit.
- Group 1: Standard of Care (SoC)
- Group 2: Encaleret
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
What degree of risk do patients take when using Encaleret?
"Our team at Power have confidently rated the security of Encaleret a 3, as it is currently in its third phase - thereby implying that evidence for both efficacy and safety has been collected."
Are there any slots available in this investigation currently?
"Affirmative. According to the clinicaltrials.gov database, this medical trial is actively looking for recruits and was first posted on 6th January 2023 with a most recent update being made 9th January 2023. 45 people are sought after at one particular site."
How many participants are presently enrolled in this clinical experiment?
"Yes, clinicaltrials.gov confirms that the medical study is actively recruiting participants and has been since January 6th, 2023. The trial was last updated on January 9th of the same year and requires 45 patients from one site to take part."
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