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Calcitriol

Product: Calcitriol injection
Indication:

Treatment for secondary hyperthyroidism in patients with late-stage chronic kidney disease

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

In China, the prevalence of chronic kidney disease (CKD) is approximately 9.3%*. From 2001 to 2006, patients undergoing hemodialysis, peritoneal dialysis and renal transplantation increased at a rate of 11% per year.

As 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 Injection

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.