| Product: | Calcitriol injection |
| Indication: | Treatment for secondary hyperthyroidism in patients with late-stage chronic kidney disease (Rx) |
| Status: | Phase III |
PUMC Pharmaceutical’s calcitriol injection enables sustained release of active Vitamin D, suppressing PTH in CKD patients.
Secondary hyperthyroidism in CKD Patients
As chronic kidney disease (CKD) progresses, the kidneys fail to convert sufficient quantities of natural vitamin D (25(OH)D) into active 1,25-dihydroxyvitamin D3 (1,25 D), a hormone regulating absorption of calcium from the gastrointestinal tract. As serum calcium falls, the parathyroid gland responds by increasing the production and secretion of parathyroid hormone (PTH), which signals the bones to release calcium into the bloodstream.
Persistent elevation of PTH, or secondary hyperparathyroidism (SHPT), is highly prevalent in CKD patients Stage 3 and higher. As the bones are leached of their calcium, CKD patients increase their risk for bone loss and calcification in the heart, lungs and/or other soft tissue.
| Stage 3 | Stage 4 | Stage 5 | |
|---|---|---|---|
| Patients with elevated PTH | 30% | 60% | 85% |
Calcitriol
Calcitriol is a vitamin D prohormone that replaces the 1,25D the kidneys fail to produce. Inactive upon administration via intravenous injection, calcitriol bypasses the diseased kidneys, and is activated in the liver to become 1,25D. Sustained release of active vitamin D results in normal serum calcium, and therefore suppression of PTH.
