Clinical Trials List
2023-08-01 - 2024-10-30
Phase III
Recruiting1
ICD-10Q92.0
Whole chromosome trisomy, nonmosaicism (meiotic nondisjunction)
ICD-10Q92.1
Whole chromosome trisomy, mosaicism (mitotic nondisjunction)
ICD-10Q92.2
Partial trisomy
ICD-10Q92.5
Duplications with other complex rearrangements
ICD-10Q92.61
Marker chromosomes in normal individual
ICD-10Q92.62
Marker chromosomes in abnormal individual
ICD-10Q92.7
Triploidy and polyploidy
ICD-10Q92.8
Other specified trisomies and partial trisomies of autosomes
ICD-10Q92.9
Trisomy and partial trisomy of autosomes, unspecified
ICD-10Q93.0
Whole chromosome monosomy, nonmosaicism (meiotic nondisjunction)
ICD-10Q93.1
Whole chromosome monosomy, mosaicism (mitotic nondisjunction)
ICD-10Q93.2
Chromosome replaced with ring, dicentric or isochromosome
ICD-10Q95.2
Balanced autosomal rearrangement in abnormal individual
ICD-10Q95.3
Balanced sex/autosomal rearrangement in abnormal individual
ICD-9758.5
Other conditions due to autosomal anomalies
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)
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Trial Applicant
MEDPACE TAIWAN LIMITED
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
● cCa in the range 8.3-10.7 mg/dL
● 24-hour UCa within reference range (men ＜ 300 mg/day, women ＜ 250 mg/day)
Inclution Criteria
Participants must have a documented pathogenic or likely pathogenic activating variant, or variant of uncertain significance, of the calcium sensing receptor (CASR) gene associated with biochemical findings of hypoparathyroidism.
Participants must have a documented history of symptoms or signs of ADH1.
Participants 16 to <18 years old must have closed growth plates on hand radiograph.
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.
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.
Participants treated with magnesium or potassium supplements must be willing to discontinue such treatment prior to the first dose of encaleret.
Participants treated with potassium-sparing diuretics must be willing to discontinue such treatment prior to the first dose of encaleret.
Participants must meet SoC Optimization criteria as defined in the protocol.
Exclusion Criteria
History of hypocalcemic seizure within the past 3 months preceding Screening.
History of thyroid or parathyroid surgery.
History of renal transplantation.
Pregnant or nursing (lactating) women, where pregnancy is confirmed by a positive beta-human chorionic gonadotropin (β-hCG) laboratory test.
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).
Blood 25-OH Vitamin D level <25 nanograms (ng)/milliliter (mL).
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).
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.
The Estimated Number of Participants
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Taiwan
5 participants
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Global
60 participants
