The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Approval Status:

Approved April 1998

Specific Treatments:

secondary hyperparathyroidism associated with chronic renal failure

Therapeutic Areas

General Information

Zemplar (paricalcitol injection) has been approved for the treatment of secondary hyperparathyroidism associated with chronic renal failure. Zemplar is the first vitamin D analog available to treat secondary hyperparathyroidism.

Clinical Results

In three placebo-controlled studies, chronic renal failure patients treated with Zemplar achieved a mean parathyroid hormone (PTH) reduction of 30% in six weeks. Additionally there was no difference in incidence of hypercalcemia or hyperphosphatemia when compared to placebo.

Side Effects

In four, placebo-controlled, double blind, multi center studies, there was no significant difference in the incidence rate for adverse events between Zemplar and placebo-treated patients. The three most frequently reported events in the Zemplar clinical studies were nausea, vomiting and edema, which are commonly seen in hemodialysis patients.