ZEMPLAR SUMMARY
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.
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NEWS HIGHLIGHTS
Published Studies Related to Zemplar (Paricalcitol)
Oral paricalcitol in the treatment of patients with CKD and proteinuria: a randomized trial. [2009.10]
BACKGROUND: Vitamin D has key roles in regulating systems that could be important in the pathobiological state of proteinuria. Because of this, it could be helpful in treating patients with proteinuric renal diseases. The objective is to determine the effect of oral paricalcitol on protein excretion in patients with proteinuric chronic kidney disease... CONCLUSIONS: Paricalcitol resulted in a significant reduction in protein excretion in patients with proteinuric renal disease.
Intravenous calcitriol versus paricalcitol in haemodialysis patients with severe secondary hyperparathyroidism. [2009.08]
AIM: Secondary hyperparathyroidism (SHPT) is common among haemodialysis patients. Intensive treatment with calcitriol is often complicated by hypercalcaemia, hyperphosphataemia and elevated calcium phosphorus (Ca X PO(4)) product. Paricalcitol is a vitamin D analogue developed to overcome some of the limitations of calcitriol therapy. The study objectives were to compare the response of intact parathyroid hormone (iPTH) and the incidence of hypercalcaemia, hyperphosphataemia and elevated Ca X PO(4) product in patients with severe SHPT treated with either i.v. calcitriol or i.v. paricalcitol... CONCLUSION: Intravenous paricalcitol may be superior to i.v. calcitriol for the treatment of severe SHPT in our chronic haemodialysis population. A larger randomized controlled trial is indicated to confirm these initial findings.
Paricalcitol treatment of secondary hyperparathyroidism in hemodialysis patients on sevelamer hydrochloride: which dialysate calcium concentration to use? [2009]
BACKGROUND: Optimal dialysate calcium concentration (DCa) has not been determined under less hypercalcemic vitamin D analogues and Ca-free phosphate (P) binders... CONCLUSIONS: Under paricalcitol and sevelamer, serum parathyroid hormone decreased without Ca increase under any DCa. DCa of 2.5 mEq/l resulted in higher paricalcitol doses, increased serum P levels and more frequent high Ca x P episodes and may not be optimal with the new medications.
Paricalcitol reduces albuminuria and inflammation in chronic kidney disease: a randomized double-blind pilot trial. [2008.08]
Vitamin D receptor activation is associated with improved survival in patients with chronic kidney disease, but the mechanism of this benefit is unclear. To better understand the effects of vitamin D on endothelial function, blood pressure, albuminuria, and inflammation in patients with chronic kidney disease (2 patients stage 2, remaining stage 3), we conducted a pilot trial in 24 patients who were randomly allocated equally to 3 groups to receive 0, 1, or 2 microg of paricalcitol, a vitamin D analog, orally for 1 month...
Calcium balance during calcitriol and paricalcitol administration in healthy humans. [2008.03]
OBJECTIVE: Secondary hyperparathyroidism in hemodialysis patients requires optimal correction of vitamin D deficiency with active vitamin D and analogues. It has been postulated that new vitamin D analogues, i.e. paricalcitol, efficiently suppress parathyroid hormone serum levels (PTH), but do not increase intestinal calcium absorption as much as calcitriol. The effects of calcitriol and paricalcitol on calcium balance can best be characterized under standardized conditions in healthy individuals with normal renal function, because the urinary calcium excretion at steady state corresponds to the net calcium absorption in the gut... CONCLUSION: Using a dosing ratio of 1:3 for calcitriol:paricalcitol, i.e. the same conversion factor used previously in studies on hemodialysis patients, only calcitriol was able to reduce iPTH levels in healthy individuals. Low-dose calcitriol reduced iPTH levels without raising calcium absorption and without including any hypercalcemia.
Clinical Trials Related to Zemplar (Paricalcitol)
Paricalcitol Injection Phase II Trial [Completed]
The PK and tolerability of paricalcitol after repeated intravenous administration for 2 weeks
(total 6 doses at every HD session) are studied in subjects with 2°HPT who are receiving HD 3
times a week for stable chronic renal failure.
A Phase 4 Study to Determine Dosing of Hectorol® Capsules When Converting From Zemplar® Injection [Completed]
Protocol HECT00306 aims to determine clinically appropriate doses of Hectorol
(doxercalciferol capsules) when converting from Zemplar (paricalcitol injection) for the
treatment of secondary hyperparathyroidism in Stage 5 chronic kidney disease on
hemodialysis.
A Phase 4 Pharmacokinetic Study of Hectorol Injection and Zemplar Injection in CKD Subjects on Hemodialysis [Completed]
This study will measure serum levels of the active Vitamin D compound that circulates in
hemodialysis subjects treated with either doxercalciferol injection (Hectorol®) or Zemplar®
(paricalcitol injection).
A Study of Paricalcitol Capsules on Reducing Albuminuria in Type 2 Diabetic Nephropathy Being Treated With Renin-Angiotensin System Inhibitors [Recruiting]
The study objective is to evaluate the effect of paricalcitol capsules on albuminuria
reduction in Chronic Kidney Disease (CKD) subjects with Type 2 diabetic nephropathy receiving
optimal ACEi and/or ARB therapy
Efficacy and Safety of 6 Months Treatment With Paricalcitol Injection or Oral in Patients With Secondary Hyperparathyroidism on Dialysis [Recruiting]
Prospective, non-randomized, multi-center study to assess the efficacy and safety of
paricalcitol injection or oral administered over 6 months to patients with secondary
hyperparathyroidism on dialysis
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