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Calcimimetic
Encaleret for Hypocalcemia
Phase 2
Waitlist Available
Research Sponsored by Calcilytix Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial is testing a new medication for a rare genetic condition that causes low calcium levels.
Eligible Conditions
- Autosomal Dominant Hypocalcemia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change From Baseline in Albumin-Corrected Blood Calcium Concentrations (cCa)
Number of Participants with Adverse Events (AEs)
Rate of Urinary Calcium Excretion
Secondary outcome measures
Area Under the Concentration-Time Curve Etrapolated to infinity (AUC0-inf)
Bone Formation Markers as Assessed by Blood Procollagen Type 1 N-Propeptide (P1NP)
Bone Resorption Markers as Assessed by Collagen Cross-Linked C-Telopeptide (CTx)
+10 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Cohort 2: Steady-State DoseExperimental Treatment1 Intervention
Participants will directly be enrolled into Period 2, and receive encaleret twice daily at a dose based on data and responses from Cohort 1 Period 1.
Period 2: Participants will receive encaleret twice daily for 5 days.
Period 3: After completion of Period 2, participants will be eligible to receive encaleret for an additional 24 weeks.
LTE: At the end of the study, participants will also have an option to receive encaleret for up to an additional 2 years.
Group II: Cohort 1: Ascending + Steady-State DoseExperimental Treatment1 Intervention
Period 1: Participants will receive an ascending dose of encaleret once daily for the first 3 days. Participants will then receive an individualized dose of encaleret twice daily for 2 days.
Period 2: Participants will receive encaleret twice daily for 5 days at a single dose level based on responses from Period 1.
Period 3: After completion of Period 2, participants will be eligible to receive encaleret for an additional 24 weeks.
Long-Term Extension (LTE): At the end of the study, participants will also have an option to receive encaleret for up to an additional 2 years.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Encaleret
2020
Completed Phase 2
~20
Find a Location
Who is running the clinical trial?
Calcilytix Therapeutics, Inc.Lead Sponsor
Calcilytix Therapeutics, Inc., a BridgeBio companyLead Sponsor
2 Previous Clinical Trials
160 Total Patients Enrolled
2 Trials studying Hypocalcemia
160 Patients Enrolled for Hypocalcemia
Calcilytix Medical DirectorStudy DirectorCalcilytix Therapeutics, Inc., a BridgeBio company
2 Previous Clinical Trials
160 Total Patients Enrolled
2 Trials studying Hypocalcemia
160 Patients Enrolled for Hypocalcemia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have received treatment with PTH 1-84 or 1-34 in the last 3 months.You have had a seizure caused by low calcium levels in the past 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1: Ascending + Steady-State Dose
- Group 2: Cohort 2: Steady-State Dose
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 new recruits still being welcomed for this trial?
"The clinicaltrials.gov website reports that this trial is no longer accepting participants; it was originally posted on September 15th 2020 and last modified on July 20th 2022. Luckily, there are still 19 different studies recruiting patients at the present time."
Answered by AI
To what extent does CLTX-305 pose a risk to participants?
"Our team at Power gave CLTX-305 a rating of 2, as there is some evidence attesting to its safety but no proof yet that it works."
Answered by AI
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