Evaluating the Safety and Efficacy of AMOR-1 as a Treatment for Hypocalcemia Associated With Hypo… (NCT06547151) | Clinical Trial Compass
RecruitingPhase 2
Evaluating the Safety and Efficacy of AMOR-1 as a Treatment for Hypocalcemia Associated With Hypoparathyroidism in Adults
Israel81 participantsStarted 2024-12-15
Plain-language summary
This clinical trial aims to evaluate the efficacy and safety of AMOR-1, consisting of Amorphous Calcium Carbonate (ACC) as the active drug substance, in treating hypocalcemia in adults with hypoparathyroidism.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. An understanding, ability, and willingness to fully comply with study procedures and restrictions.
✓. Ability to voluntarily provide written, signed, and dated informed consent as applicable to participants in the study.
✓. Adult males or females 18 or older (prior to screening). Those \< 25 years old will be examined radiologically (Bone age X-ray of non-dominant wrist and hand) to ensure epiphyseal closure prior to enrollment into the study.
✓. Hypoparathyroidism patients, from any etiology, who are on currently available Standard of Care (SoC) e.g., calcium supplement and active vitamin D metabolite/analog.
✓. Oral calcium ≥ 1000 mg QD above the normal dietary calcium intake
✓. Albumin-adjusted total serum calcium concentration level between 7.5 mg/dL and 10.5 mg/dL, or if outside of this range, considered not clinically significant by the Investigator.
✓. Vitamin D metabolite/analog therapy with calcitriol ≥0.25μg QD or alfacalcidol ≥0.50 μg QD.
✓. Serum 25-hydroxyvitamin D (25OHD) ≥50 nmol/l (20 ng/ml), or if below, considered not clinically significant by the Investigator.
Exclusion criteria
✕. Any disease that might affect calcium metabolism or calcium-phosphate homeostasis other than hypoparathyroidism, such as active hyperthyroidism, Paget's disease of bone, Type 1 or poorly controlled Type 2 diabetes mellitus (HbA1c \> 9%), acromegaly, multiple endocrine neoplasia types I and II, Cushing's syndrome or disease, acute pancreatitis, malnutrition, recent prolonged immobility.
What they're measuring
1
Percentage of Subjects Who Achieved the Primary Composite Endpoint at Week 14
✕. Severe liver disease (Child-Pugh score \>9) (US FDA, 2003) or hepatic transaminases (ALT and AST) \> 3 times the upper limit.
✕. Severe renal insufficiency defined as estimated glomerular filtration rate (eGFR) \< 30 ml/min/1.73 m2.
✕. Clinical history of symptomatic renal stones within the past 3 months. Subjects with asymptomatic renal stones are permitted.
✕. Poorly controlled short bowel syndrome, bowel resection, tropical sprue, celiac disease, ulcerative colitis, and Crohn's disease.
✕. Chronic or severe cardiac disease within the past 6 months including but not limited to heart failure classified as NYHA Class II-IV (Dolgin and NYHA, 1994), uncontrolled arrhythmias, bradycardia (resting heart rate \< 48 beats/minute), QTc \>450msec (males) or \>470 msec (females) on ECG.
✕. History of active or untreated malignancy (excluding thyroid cancer or basal cell skin cancer) within the past 2 years. For thyroid cancers, low-risk well-differentiated thyroid cancer that is stable does not require a disease-free period. High-risk thyroid cancer or uncontrolled cases must be disease-free for at least 1 year prior to Screening.
✕. Seizure disorder/epilepsy with a history of a seizure within the previous 6 months prior to screening.