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ACTIVE NOT RECRUITING
NCT05680818
PHASE3

Efficacy and Safety of Encaleret Compared to Standard of Care in Participants With ADH1

Sponsor: Calcilytix Therapeutics, Inc., a BridgeBio company

View on ClinicalTrials.gov

Summary

The primary purpose of the study is to understand the effectiveness, safety, and tolerability of encaleret when compared to standard of care (SoC) treatment in participants with Autosomal Dominant Hypocalcemia Type 1 (ADH1).

Official title: CALIBRATE: A Phase 3, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Encaleret Compared to Standard of Care in Participants With Autosomal Dominant Hypocalcemia Type 1 (ADH1)

Key Details

Gender

All

Age Range

16 Years - Any

Study Type

INTERVENTIONAL

Enrollment

67

Start Date

2023-01-06

Completion Date

2029-08

Last Updated

2025-10-31

Healthy Volunteers

No

Interventions

DRUG

Encaleret

Administered as film-coated tablet for oral use

DIETARY_SUPPLEMENT

Standard of Care

Calcium supplements and/or active Vitamin D (calcitriol, alfacalcidol, falecalcitriol, etc.)

Locations (25)

UCSF Benioff Children's Hospital, Oakland

Oakland, California, United States

Children's Hospital Colorado

Aurora, Colorado, United States

Indiana University Health University Hospital

Indianapolis, Indiana, United States

NIH

Bethesda, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Mayo Clinic - Rochester

Rochester, Minnesota, United States

Columbia University Irving Medical Center

New York, New York, United States

Physicians East

Greenville, North Carolina, United States

Ohio State University Medical Center

Columbus, Ohio, United States

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Houston Methodist Hospital

Houston, Texas, United States

Royal North Shore Hospital

Saint Leonards, New South Wales, Australia

Royal Brisbane and Women's Hospital

Herston, Queensland, Australia

Bone Research & Education Centre

Oakville, Ontario, Canada

Vseobecna fakultni nemocnice v Praze

New Town, Czechia

Aarhus University Hospital

Aarhus, Denmark

CHU Bicetre

Le Kremlin-Bicêtre, Le Kremlin-Bicêtre, France

Hôpital Edouard Herriot - HCL

Lyon, France

IRCCS Ospedale San Raffaele

Milan, Italy

University Hospital of Pisa

Pisa, Italy

Fondazione Policlinico Universitario Campus Bio-Medico

Roma, Italy

The University of Tokyo Hospital

Tokyo, Japan

Eramus MC

Rotterdam, Netherlands

Freeman Hospital

Newcastle upon Tyne, United Kingdom

Norfolk and Norwich University Hospital

Norwich, United Kingdom