Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06547151
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-07
Brief Title:
Evaluating the Safety and Efficacy of AMOR-1 as a Treatment for Hypocalcemia Associated With Hypoparathyroidism in Adults
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 2 Prospective Multinational Multicenter Double-Blind Randomized Study to Evaluate the Safety and Efficacy of AMOR-1 as a Treatment of Hypocalcemia Associated With Hypoparathyroidism by Replacement of Currently Used Calcium Supplements CS in Adults
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
AMOR-1 contains Amorphous Calcium Carbonate ACC nanoparticles which provide higher calcium absorption and bioavailability compared to the crystalline form Therefore significantly smaller doses of elemental calcium provided by ACC may be sufficient to maintain the desired serum calcium levels in people with hypoparathyroidism The lower calcium doses can potentially reduce the adverse effects associated with long-term high daily doses of calcium supplementation consumed by these patients
The main question for the study is Can replacing the current calcium supplement with AMOR-1 which contains half the amount of elemental calcium maintain blood calcium levels in people with hypoparathyroidism Patients with a history of hypoparathyroidism will be randomized in a 21 ratio to receive either AMOR-1 or Control the conventional crystalline calcium carbonate supplement respectively Their current dose of calcium supplement will be gradually replaced with AMOR-1 or the Control over 2-4 weeks At the end of the replacement phase participants in the AMOR-1 arm are anticipated to receive 50 of the elemental calcium compared to their initial intake from the crystalline calcium supplements Subjects in the Control arm will maintain their initial elemental calcium intake Following this replacement phase the participants will continue receiving their individual dose of AMOR-1 or the Control for an additional 10-12 weeks Dose Maintenance phase At the end of this phase the participants will revert to their initial calcium supplement and will be monitored for an additional month until the end of the study All participants will receive an active form of vitamin D in parallel to the study treatment Throughout the study participants will be routinely monitored for safety and efficacy including calcium levels in the blood and urine
The main question for the study is Can replacing the current calcium supplement with AMOR-1 which contains half the amount of elemental calcium maintain blood calcium levels in people with hypoparathyroidism Patients with a history of hypoparathyroidism will be randomized in a 21 ratio to receive either AMOR-1 or Control the conventional crystalline calcium carbonate supplement respectively Their current dose of calcium supplement will be gradually replaced with AMOR-1 or the Control over 2-4 weeks At the end of the replacement phase participants in the AMOR-1 arm are anticipated to receive 50 of the elemental calcium compared to their initial intake from the crystalline calcium supplements Subjects in the Control arm will maintain their initial elemental calcium intake Following this replacement phase the participants will continue receiving their individual dose of AMOR-1 or the Control for an additional 10-12 weeks Dose Maintenance phase At the end of this phase the participants will revert to their initial calcium supplement and will be monitored for an additional month until the end of the study All participants will receive an active form of vitamin D in parallel to the study treatment Throughout the study participants will be routinely monitored for safety and efficacy including calcium levels in the blood and urine
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None