ट्रायल रडार AI | ||
|---|---|---|
क्लिनिकल ट्रायल NCT05680818 (CALIBRATE) के लिए Autosomal Dominant Hypocalcemia (ADH) वर्तमान में सक्रिय, भर्ती नहीं है। सभी विवरणों के लिए क्लिनिकल ट्रायल रडार कार्ड दृश्य और AI खोज उपकरण देखें, या यहाँ कुछ भी पूछें। | ||
एक परीक्षण फ़िल्टर मानदंडों से मेल खाता है
कार्ड दृश्य
Efficacy and Safety of Encaleret Compared to Standard of Care in Participants With ADH1 (CALIBRATE)
चिकित्सा परीक्षण का विवरण मुख्य रूप से अंग्रेजी में उपलब्ध है। हालाँकि, ट्रायल रडार AI मदद कर सकता है! बस 'परीक्षण समझाएं' पर क्लिक करें और अपनी चुनी हुई भाषा में परीक्षण की जानकारी देखें और चर्चा करें।
क्लिनिकल परीक्षण NCT05680818 (CALIBRATE) का मुख्य उद्देश्य उपचार का अध्ययन करना है। यह चिकित्सकीय अध्ययन Autosomal Dominant Hypocalcemia (ADH) से जुड़ा हुआ है और यह एक चरण III हस्तक्रियात्मक परीक्षण है। परीक्षण वर्तमान में सक्रिय, भर्ती नहीं चल रहा है। इसकी शुरुआत 6 जनवरी 2023 को हुई थी, और इसमें कुल 67 प्रतिभागियों के नामांकन की योजना है। Calcilytix Therapeutics, Inc., a BridgeBio company इस परीक्षण का नेतृत्व कर रहे हैं और इसके 1 अगस्त 2029 तक पूरा होने की उम्मीद है। ClinicalTrials.gov वेबसाइट पर यह जानकारी 31 अक्तूबर 2025 को अंतिम बार अपडेट की गई थी।
संक्षिप्त सारांश
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).
आधिकारिक शीर्षक
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)
चिकित्सीय स्थितियाँ
Autosomal Dominant Hypocalcemia (ADH)अन्य अध्ययन आईडी
- CALIBRATE
- CLTX-305-302
NCT नंबर
अध्ययन प्रारंभ तिथि (वास्तविक)
2023-01-06
अंतिम अद्यतन प्रकाशित
2025-10-31
अध्ययन की समाप्ति तिथि (अनुमानित)
2029-08
नामांकन (अनुमानित)
67
अध्ययन प्रकार
हस्तक्रियात्मक
चरण
चरण III
स्थिति
सक्रिय, भर्ती नहीं
प्रमुख शब्द
Autosomal Dominant Hypocalcemia Type 1 (ADH1)
Hypocalcemia
Musculoskeletal Diseases
Muscular Diseases
Musculoskeletal Abnormalities
Calcium Metabolism Disorders
Metabolic Diseases
Hypoparathyroidism
Hypocalcemic Seizures
Hypercalciuria
Nephrocalcinosis
Nephrolithiasis
Calcium Sensing Receptor
Encaleret
Hypopara
Hypocalcemia
Musculoskeletal Diseases
Muscular Diseases
Musculoskeletal Abnormalities
Calcium Metabolism Disorders
Metabolic Diseases
Hypoparathyroidism
Hypocalcemic Seizures
Hypercalciuria
Nephrocalcinosis
Nephrolithiasis
Calcium Sensing Receptor
Encaleret
Hypopara
प्राथमिक उद्देश्य
उपचार
डिज़ाइन आवंटन
यादृच्छिक
हस्तक्षेप मॉडल
अनुक्रमिक
अंधकरण
कोई नहीं (खुलें लेबल)
समूह/हस्तक्षेप
| प्रतिभागी समूह/हाथ | हस्तक्षेप/इलाज |
|---|---|
प्रयोगात्मकEncaleret Participants will receive encaleret at a dose as needed based on calcium levels. | Encaleret Administered as film-coated tablet for oral use |
अन्यStandard of Care (SoC) Participants will continue receiving calcium supplements and/or active Vitamin D (calcitriol, alfacalcidol, falecalcitriol, etc.) | देखभाल का मानक Calcium supplements and/or active Vitamin D (calcitriol, alfacalcidol, falecalcitriol, etc.) |
प्राथमिक परिणाम माप
द्वितीयक परिणाम माप
| परिणाम माप | माप विवरण | समय सीमा |
|---|---|---|
Number of Responders who Achieve Both Albumin-Corrected Blood Calcium (cCa) and 24-hour Urinary Calcium (UCa) Within the Target Range | * cCa within 8.3-10.7 mg/dL (2.08-2.68 millimoles per liter \[mmol/L\])
* 24-hr UCa within the reference range (\< 300 mg/day for men \[7.5 mmol/day\], \< 250 mg/day for women \[6.25 mmol/day\]) | Up to Week 24 |
| परिणाम माप | माप विवरण | समय सीमा |
|---|---|---|
Number of Participants With Intact Parathyroid Hormone (iPTH) Within or Greater than the Reference Range | Up to Week 24 | |
Number of Participants who Achieve Blood Magnesium Within the Reference Range | Up to Week 24 | |
Number of Participants who Achieve Blood Phosphate Within the Reference Range | Up to Week 24 | |
Change From Baseline in Blood 1,25-(OH)2 Vitamin D | Baseline to Week 24 | |
Change From Baseline in cCa | Baseline to Week 24 | |
Change From Baseline in 24-hour UCa | Baseline to Week 24 | |
Change From Baseline in iPTH | Baseline to Week 24 | |
Change From Baseline in Blood Phosphate and Blood Magnesium | Baseline to Week 24 | |
Change From Baseline in Urine Magnesium, Phosphate, Sodium, and Citrate Handling | Baseline to Week 24 | |
Change From Baseline in QT Interval Corrected for Changes in the Heart Rate With Fridericia Formula (QTcF) as Assessed by Electrocardiogram (ECG) | Baseline to Week 24 | |
Change from Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Score and Mental Component Score and Each of the Sub-Domains | Baseline to Week 24 | |
Number of Participants in the Encaleret Arm Receiving Calcium and/or Vitamin D Supplements | Up to Week 24 | |
Steady State Encaleret Trough Concentration (Ctrough) | Up to Week 24 |
पात्रता मानदंड
अध्ययन के लिए पात्र आयु
बच्चा, वयस्क, वृद्ध वयस्क
अध्ययन के लिए न्यूनतम आयु
16 Years
अध्ययन के लिए पात्र लिंग
सभी
- 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.
- 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.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Calcilytix Therapeutics, Inc., a BridgeBio companyकोई संपर्क डेटा नहीं।
25 10 देशों में अध्ययन स्थल
California
UCSF Benioff Children's Hospital, Oakland, Oakland, California, 94609, United States
Colorado
Children's Hospital Colorado, Aurora, Colorado, 80045, United States
Indiana
Indiana University Health University Hospital, Indianapolis, Indiana, 46202, United States
Maryland
NIH, Bethesda, Maryland, 20892, United States
Massachusetts
Massachusetts General Hospital, Boston, Massachusetts, 02114, United States
Minnesota
Mayo Clinic - Rochester, Rochester, Minnesota, 55905, United States
New York
Columbia University Irving Medical Center, New York, New York, 10032, United States
North Carolina
Physicians East, Greenville, North Carolina, 27834, United States
Ohio
Ohio State University Medical Center, Columbus, Ohio, 43203, United States
Pennsylvania
The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, 19104, United States
Texas
Houston Methodist Hospital, Houston, Texas, 77030, United States
New South Wales
Royal North Shore Hospital, Saint Leonards, New South Wales, 2065, Australia
Queensland
Royal Brisbane and Women's Hospital, Herston, Queensland, 4029, Australia
Ontario
Bone Research & Education Centre, Oakville, Ontario, L6M 1M1, Canada
Vseobecna fakultni nemocnice v Praze, New Town, 128 08, Czechia
Aarhus University Hospital, Aarhus, 8200, Denmark
Le Kremlin-Bicêtre
CHU Bicetre, Le Kremlin-Bicêtre, Le Kremlin-Bicêtre, 94270, France
Hôpital Edouard Herriot - HCL, Lyon, 69003, France
IRCCS Ospedale San Raffaele, Milan, 20132, Italy
University Hospital of Pisa, Pisa, 56124, Italy
Fondazione Policlinico Universitario Campus Bio-Medico, Roma, 00128, Italy
The University of Tokyo Hospital, Tokyo, 113-8655, Japan
Eramus MC, Rotterdam, 3015 AA, Netherlands
Freeman Hospital, Newcastle upon Tyne, NE7 7DN, United Kingdom
Norfolk and Norwich University Hospital, Norwich, NR4 7UY, United Kingdom