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Zemplar (Paricalcitol) - Summary

 
 



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)

Paricalcitol Versus Ergocalciferol for Secondary Hyperparathyroidism in CKD Stages 3 and 4: A Randomized Controlled Trial. [2011.08.30]
BACKGROUND: The efficacy of 25-hydroxyvitamin D (25[OH]D) supplementation versus vitamin D receptor activators for the treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) stages 3 or 4 and vitamin D deficiency is unclear... CONCLUSIONS: Paricalcitol is more effective than ergocalciferol at decreasing PTH levels in patients with CKD stages 3 or 4 with vitamin D deficiency and SHPT. Published by Elsevier Inc.

Selective vitamin D receptor activation with paricalcitol for reduction of albuminuria in patients with type 2 diabetes (VITAL study): a randomised controlled trial. [2010.11.06]
BACKGROUND: Despite treatment with renin-angiotensin-aldosterone system (RAAS) inhibitors, patients with diabetes have increased risk of progressive renal failure that correlates with albuminuria. We aimed to assess whether paricalcitol could be used to reduce albuminuria in patients with diabetic nephropathy... INTERPRETATION: Addition of 2 mug/day paricalcitol to RAAS inhibition safely lowers residual albuminuria in patients with diabetic nephropathy, and could be a novel approach to lower residual renal risk in diabetes. FUNDING: Abbott.

Effect of paricalcitol on the urinary peptidome of kidney transplant patients. [2010.10]
BACKGROUND AND OBJECTIVE: Disorders in bone mineral metabolism are common after kidney transplantation, covering, among other pathologic conditions, secondary hyperparathyroidism. Paricalcitol, a selective vitamin D receptor activator, is indicated in the prevention and treatment of secondary hyperparathyroidism. Recent evidence suggests that paricalcitol is also associated, by mechanisms not yet clarified, with improved patient survival. To clarify these unknown mechanisms, the aim of this study was to determine whether 3 months of treatment with paricalcitol modified the urinary peptidome of kidney transplant patients... CONCLUSIONS: With this preliminary study, we obtained a profile of urinary peptides in which changes occurred due to treatment with paricalcitol. The identification of proteins to which these peptides belong may improve our knowledge about the possible pleiotropic effects of paricalcitol. Copyright (c) 2010 Elsevier Inc. All rights reserved.

Differential effects of paricalcitol and calcitriol on intestinal calcium absorption in hemodialysis patients. [2010]
BACKGROUND/AIMS: Increased parathyroid activity associated with chronic kidney disease is often managed with calcitriol, which can elevate serum calcium (Ca) by increasing bone resorption and intestinal absorption, whereas paricalcitol promotes less bone resorption. This study compared intestinal Ca absorption in hemodialysis patients treated with calcitriol versus paricalcitol (dose ratio 1:3)... CONCLUSION: Overall, paricalcitol-treated patients absorbed approximately 14% less Ca compared with calcitriol-treated patients with similar effects on PTH. In hemodialysis patients, paricalcitol may provide a benefit by lowering the Ca available for removal by dialysis and/or for deposit in bone or soft tissues. Copyright (c) 2009 S. Karger AG, Basel.

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.

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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 HectorolŽ Capsules When Converting From ZemplarŽ 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.

The Effect of Paricalcitol on Creatinine Filtration, Secretion and Glomerular Filtration Rate [Recruiting]
The purpose of this study is to study the effects of Paricalcitol (Zemplar) on kidney functioning. The investigators hypothesize that the increase in serum creatinine observed in recent paricalcitol trials is a function of reduced creatinine secretion and not an actual reduction in kidney function. 16 patients will have kidney function measured via iothalamate clearance at baseline, after 7 days of paricalcitol treatment and after 7 days of being washed off the paricalcitol.

Long-Term Therapy Outcomes When Treating Chronic Kidney Disease Patients With Paricalcitol in German and Austrian Clinical Practice [Recruiting]
The purpose of this study is to obtain data on the safety and effectiveness of ZemplarŽ injection and ZemplarŽ capsules in real-life clinical practice. In this study, ZemplarŽ will be prescribed on an on-label basis in an everyday setting. A period of 12 months has been consciously chosen in order to also obtain experience on the maintenance dose and treatment optimization with ZemplarŽ injection and ZemplarŽ capsules in long-term use.

Oral Paricalcitol in Kidney Transplant Recipients [Recruiting]
This study is being done to find out whether patients who receive a kidney transplant can benefit from taking the medication paricalcitol (trade name ZemplarŽ) compared to kidney transplant recipients not taking this medication. The main possible benefits that are being studied are:

- Lower risk for overactive parathyroid glands after kidney transplantation.

- Lower risk of low bone density in the spine and hip after kidney transplantation. By

dividing patients in the study into a group receiving ZemplarŽ and a group not receiving ZemplarŽ, it will be possible to understand the good and bad effects of ZemplarŽ during the first year after a kidney transplant.

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Reports of Suspected Zemplar (Paricalcitol) Side Effects

Dyspnoea (26)Death (17)Cardiac Failure (16)Diarrhoea (16)Renal Failure Chronic (15)Fatigue (14)Dizziness (14)Myocardial Infarction (14)Nausea (13)Cardiac Arrest (13)more >>


Page last updated: 2011-12-09

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