Zemplar (Paricalcitol) - Summary

ZEMPLAR SUMMARY

ZEMPLAR®
(paricalcitol) Injection
Fliptop Vial

Zemplar^® (paricalcitol injection) is a synthetically manufactured vitamin D analog. It is available as a sterile, clear, colorless, aqueous solution for intravenous injection. Each mL contains paricalcitol, 5 mcg; propylene glycol, 30% (v/v); and alcohol, 20% (v/v).

Zemplar^® is indicated for the prevention and treatment of secondary hyperparathyroidism associated with chronic renal failure. Studies in patients with chronic renal failure show that Zemplar^® suppresses PTH levels with no significant difference in the incidence of hypercalcemia or hyperphosphatemia when compared to placebo. However, the serum phosphorus, calcium and calcium × phosphorus product (Ca × P) may increase when Zemplar^® is administered.

ZEMPLAR NEWS HIGHLIGHTS

Published Studies Related to Zemplar (Paricalcitol)

Paricalcitol reduces albuminuria and inflammation in chronic kidney disease: a randomized double-blind pilot trial. [2008.08]

Calcium balance during calcitriol and paricalcitol administration in healthy humans. [2008.03]

Oral paricalcitol for the treatment of secondary hyperparathyroidism in patients on hemodialysis or peritoneal dialysis. [2008]

Intravenous paricalcitol for treatment of secondary hyperparathyroidism in children on hemodialysis. [2007.06]

Effect of omeprazole on the pharmacokinetics of paricalcitol in healthy subjects. [2007.03]

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Clinical Trials Related to Zemplar (Paricalcitol)

Paricalcitol Injection Phase II Trial [Completed]

A Phase 4 Study to Determine Dosing of Hectorol® Capsules When Converting From Zemplar® Injection [Completed]

A Phase 4 Pharmacokinetic Study of Hectorol Injection and Zemplar Injection in CKD Subjects on Hemodialysis [Completed]

A Study of Paricalcitol Capsules on Reducing Albuminuria in Type 2 Diabetic Nephropathy Being Treated With Renin-Angiotensin System Inhibitors [Recruiting]

Oral Paricalcitol in Kidney Transplant Recipients [Recruiting]

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