Efficacy and Safety of Encaleret Compared to Standard of Care in Participants With ADH1
NCT ID: NCT05680818
Last Updated: 2025-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
67 participants
INTERVENTIONAL
2023-01-06
2029-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Encaleret
Participants will receive encaleret at a dose as needed based on calcium levels.
Encaleret
Administered as film-coated tablet for oral use
Standard of Care (SoC)
Participants will continue receiving calcium supplements and/or active Vitamin D (calcitriol, alfacalcidol, falecalcitriol, etc.)
Standard of Care
Calcium supplements and/or active Vitamin D (calcitriol, alfacalcidol, falecalcitriol, etc.)
Interventions
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Encaleret
Administered as film-coated tablet for oral use
Standard of Care
Calcium supplements and/or active Vitamin D (calcitriol, alfacalcidol, falecalcitriol, etc.)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Participants must have a documented history of symptoms or signs of ADH1.
3. Participants 16 to \<18 years old must have closed growth plates on hand radiograph.
4. Participants treated with thiazide diuretics must discontinue thiazides for at least 14 days prior to SoC Optimization Visit 1 through Week 24 (Period 3). When the thiazide is being used as an antihypertensive, alternative therapy will be prescribed by the Investigator as needed.
5. Participants treated with phosphate binders (other than calcium salts) must discontinue the phosphate binders at least one day prior to the SoC Optimization Visit 1.
6. Participants treated with magnesium or potassium supplements must be willing to discontinue such treatment prior to the first dose of encaleret.
7. Participants treated with potassium-sparing diuretics must be willing to discontinue such treatment prior to the first dose of encaleret.
8. Participants must meet SoC Optimization criteria as defined in the protocol.
Exclusion Criteria
2. History of thyroid or parathyroid surgery.
3. History of renal transplantation.
4. Pregnant or nursing (lactating) women, where pregnancy is confirmed by a positive beta-human chorionic gonadotropin (β-hCG) laboratory test.
5. History of treatment with parathyroid hormone (PTH) 1-84 or 1-34 within the 2 months preceding Screening and requiring SoC doses exceeding \>1.2× their pre-PTH treatment total daily doses or bone turnover markers, Collagen cross-linked C-telopeptide (CTx )and Procollagen type 1 N-propeptide (P1NP), \> upper limit of normal for sex, age (men only) and menopausal status (women only).
6. Blood 25-OH Vitamin D level \<25 nanograms (ng)/milliliter (mL).
7. Estimated glomerular filtration rate (eGFR) \<30 mL/minute/1.73 m\^2 using chronic kidney disease-EPI creatinine equation refit without the race variable (chronic kidney disease-EPI creatinine equation refit without the race variable \[CKD-EPIcr\_R\]) (for participants \<18 years old the Bedside Schwartz equation should be used).
8. Participants with positive Hepatitis B surface antigen (HBsAg), Hepatitis A immunoglobulin M (IgM), or human immunodeficiency virus (HIV) viral serology test at the Screening Visit. Participants who are in complete remission from Hepatitis C virus (HCV) as evidenced by sensitive assay ≥12 weeks after completion of HCV therapy may participate in the study.
16 Years
ALL
No
Sponsors
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Calcilytix Therapeutics, Inc., a BridgeBio company
INDUSTRY
Responsible Party
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Principal Investigators
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Calcilytix Medical Director
Role: STUDY_DIRECTOR
Calcilytix Therapeutics, Inc., a BridgeBio company
Locations
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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
Countries
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Other Identifiers
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CLTX-305-302
Identifier Type: -
Identifier Source: org_study_id
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