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Calcium-sensing receptor antagonist

Encaleret for Hypocalcemia (CALIBRATE Trial)

Phase 3
Recruiting
Research Sponsored by Calcilytix Therapeutics, Inc., a BridgeBio company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants 16 to <18 years old must have closed growth plates on hand radiograph
Participants must have a documented history of symptoms or signs of ADH1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 24
Awards & highlights

CALIBRATE Trial Summary

This trial will test how well a new medication works to treat a rare calcium imbalance condition compared to current treatment.

Who is the study for?
This trial is for people with a genetic variant causing hypoparathyroidism (ADH1), aged 16-18 with closed growth plates, not on certain diuretics or supplements, and meeting specific treatment criteria. Excluded are those recently on PTH treatments, had seizures or thyroid surgery, pregnant/nursing women, low Vitamin D levels, certain viral infections, or severely reduced kidney function.Check my eligibility
What is being tested?
The study aims to compare the effectiveness and safety of encaleret against standard care in treating ADH1. Participants will receive either encaleret or the usual treatment without knowing which one they're getting to measure differences in health outcomes.See study design
What are the potential side effects?
While the side effects of encaleret aren't detailed here, common reactions to new medications may include nausea, headaches, allergic reactions or skin rashes. The trial will monitor participants closely for any adverse effects that arise during the study.

CALIBRATE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 16-17 years old and my growth plates are closed.
Select...
I have shown symptoms or signs of ADH1.
Select...
I have a genetic variant in the CASR gene linked to low parathyroid hormone levels.
Select...
I will stop taking phosphate binders one day before my first optimization visit.
Select...
I am willing to stop taking magnesium or potassium supplements before starting encaleret.
Select...
I am willing to stop taking potassium-sparing diuretics before starting encaleret.

CALIBRATE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Responders who Achieve Both Albumin-Corrected Blood Calcium (cCa) and 24-hour Urinary Calcium (UCa) Within the Target Range
Secondary outcome measures
Change From Baseline in 24-hour UCa
Change From Baseline in Blood 1,25-(OH)2 Vitamin D
Change From Baseline in Blood Phosphate and Blood Magnesium
+10 more

CALIBRATE Trial Design

2Treatment groups
Experimental Treatment
Group I: Standard of Care (SoC)Experimental Treatment1 Intervention
Participants will continue receiving calcium supplements and/or active Vitamin D (calcitriol, alfacalcidol, falecalcitriol, etc.)
Group II: EncaleretExperimental Treatment1 Intervention
Participants will receive encaleret at a dose as needed based on calcium levels.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Standard of Care
2017
Completed Phase 4
~4420
Encaleret
2020
Completed Phase 2
~20

Find a Location

Who is running the clinical trial?

Calcilytix Therapeutics, Inc., a BridgeBio companyLead Sponsor
2 Previous Clinical Trials
113 Total Patients Enrolled
2 Trials studying Hypocalcemia
113 Patients Enrolled for Hypocalcemia
Calcilytix Medical DirectorStudy DirectorCalcilytix Therapeutics, Inc., a BridgeBio company
2 Previous Clinical Trials
113 Total Patients Enrolled
2 Trials studying Hypocalcemia
113 Patients Enrolled for Hypocalcemia

Media Library

Encaleret (Calcium-sensing receptor antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT05680818 — Phase 3
Hypocalcemia Research Study Groups: Standard of Care (SoC), Encaleret
Hypocalcemia Clinical Trial 2023: Encaleret Highlights & Side Effects. Trial Name: NCT05680818 — Phase 3
Encaleret (Calcium-sensing receptor antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05680818 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~7 spots leftby Jun 2024