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Calcium per · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Calcium Acetate Oral Solution 667 mg per 5 mL |
| 2 | ACTIVE_COMPARATOR | Calcium Acetate 667 mg Gelcaps |
| 3 | OTHER | Calcium Citrate 950 mg Caplets |
| Name | Type | Description |
|---|---|---|
| Calcium Acetate Oral Solution 667 mg per 5 mL | DRUG | Drug: Calcium acetate oral solution 667 mg calcium acetate, USP per 5 mL (169 mg of elemental calcium per 5 mL); Dosage: 30 mL of calcium acetate oral solution; Dosage frequency: three times per day with meals; Duration: 3 days and the morning of day 4, in total ten doses |
| Calcium Acetate 667 mg GelCaps | DRUG | Drug: PhosLo GelCaps (calcium acetate) 667 mg (169 mg of elemental calcium per gelcap); Dosage: 6 gelcaps; Dosage frequency: three times per day with meals; Duration: 3 days and the morning of day 4, in total ten doses. |
| Calcium Citrate 950 mg Caplets | DIETARY_SUPPLEMENT | Drug: Calcium Citrate 950 mg Caplets (200 mg of elemental calcium per caplet); Dosage: 5 caplets; Dosage frequency: three times per day with meals; Duration: 3 days and the morning of day 4, in total ten doses |
Inclusion Criteria: * Signed and dated informed consent form * Ages: 18-75 years * Serum Calcium level 8.6-10.2 mg/dL * 25 vitamin D level 20-100 ng/mL * 1, 25 dihydroxy vitamin D level 6-62 pg/mL * Fasting glucose level of 65-99 mg/dL (min 8 hr fast) * iPTH level of 10-65 pg/mL * Serum phosphorous...
Calcium per is a small molecule therapy being developed by Fresenius Medical Care AG for hyperphosphatemia, a condition of elevated phosphate levels in the blood often seen in kidney disease. It is an oral solution formulation of calcium acetate, given at 667 mg per 5 mL, and is in Phase 1 clinical development.
Calcium per is being studied for the treatment of hyperphosphatemia, a nephrology condition in which phosphate accumulates in the blood. The development program focuses on an oral liquid form of calcium acetate, 667 mg per 5 mL, intended as a phosphate-binding therapy for patients with elevated phosphate levels.
Calcium per is being developed by Fresenius Medical Care AG, which trades under the ticker FMS. The company is advancing the oral calcium acetate solution as a candidate for hyperphosphatemia, with one completed Phase 1 trial conducted in the United States.
Calcium per is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. As an investigational product, it has not been approved by the FDA and remains in clinical development for hyperphosphatemia.
Calcium per has been evaluated in one completed Phase 1 trial, NCT00742820, titled a bioequivalence study comparing calcium acetate oral solution versus calcium acetate gelcaps in healthy volunteers. The trial enrolled 46 participants in the United States, used an active-controlled, randomized design, and included healthy volunteers aged 18 years and older.