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Study of Zemplar iv in Patients With End Stage Chronic Kidney Disease, Undergoing Haemodialysis

2014-08-27 03:15:18 | BioPortfolio

Summary

This is the post-marketing study conducted in two countries: Croatia and Serbia. In both countries Zemplar is the first injectable form of any Vitamin D Receptor (VDR) activator available for patients on hemodialysis. The evaluation of outcomes of VDR activator treatments in clinical practice is a major challenge in the management of this patient population. The aim of this post-marketing observational study is to obtain further data on the outcomes of Zemplar Injection administration during routine clinical use.

Description

This study is a non-interventional, observational study in which Zemplar® Injection is prescribed in the usual manner in accordance with the terms of the local marketing authorization with regards to dose, population and indication. The study population consists of subjects receiving hemodialysis in whom the diagnosis of secondary hyperparathyroidism has been established, and who are not adequately controlled with the oral VDR activator (calcitriol or alfacalcidol). Subjects will be included via consecutive sampling. To be included, subjects should have a clinical indication to initiate treatment with Zemplar® Injection due to: (1) a diagnosis of secondary hyperparathyroidism and (2) because they require a change in treatment for secondary hyperparathyroidism (e.g. due to a lack of effectiveness of the previous treatment). Each patient will be observed during his/her Zemplar® Injection treatment regimen for a maximum period of 12 months.

Study Design

Time Perspective: Prospective

Conditions

Secondary Hyperparathyroidism

Intervention

paricalcitol iv (Zemplar iv)

Location

Site Reference ID/Investigator# 27525
Dubrovnik
Croatia
20000

Status

Completed

Source

Abbott

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:18-0400

Clinical Trials [177 Associated Clinical Trials listed on BioPortfolio]

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

Protocol HECT00306 aims to determine clinically appropriate doses of Hectorol (doxercalciferol capsules) when converting from Zemplar (paricalcitol injection) for the treatment of secondar...

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

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® (pari...

Safety and Effectiveness of Zemplar Injection in Decreasing iPTH Levels in Pediatric ESRD Subjects on Hemodialysis

The purpose of this study is to see if Zemplar, a vitamin D medication, safely and effectively decreases parathyroid hormone in children ages 2-20 with End Stage Renal Disease.

Long-Term Therapy Outcomes When Treating Chronic Kidney Disease (CKD) Patients With Zemplar (Paricalcitol) in German Clinical Practice

The purpose of this study is to obtain data on the safety and effectiveness of Zemplar® injection and Zemplar® capsules in real-life clinical practice. In this study, Zemplar® will be p...

Initial Dosing of Paricalcitol in Secondary Hyperparathyroidism

The purpose of this study was to compare two different initial dosing schemes for the administration of paricalcitol in hemodialysis patients with secondary hyperparathyroidism: the alread...

PubMed Articles [3652 Associated PubMed Articles listed on BioPortfolio]

Severe secondary hyperparathyroidism in patients on haemodialysis is associated with a high initial serum parathyroid hormone and beta-CrossLaps level: Results from an incident cohort.

Secondary hyperparathyroidism (SHPT) is a frequent complication of renal disease and most commonly occurs in patients on haemodialysis (HD) with metabolic, vascular, endocrine, and bone complications....

Therapeutic experience of severe and recurrent secondary hyperparathyroidism in a patient on hemodialysis for 18 years: A case report.

For patients with refractory secondary hyperparathyroidism (SHPT), parathyroidectomy (PTX) has received increasing attention. However, evidence-based medicine shows that there is still controversy reg...

Analysis of the role of thyroidectomy and thymectomy in the surgical treatment of secondary hyperparathyroidism.

Parathyroidectomy can be subtotal or total with an autograft for the treatment of renal hyperparathyroidism. In both cases, it may be extended with bilateral thymectomy and total or partial thyroidect...

Ischemic Stroke in the Setting of Secondary Hyperparathyroidism Due to Vitamin D Deficiency: Running Title: Ischemic Stroke and Hyperparathyroidism.

Phase 2b study of evocalcet (KHK7580), a novel calcimimetic, in Japanese patients with secondary hyperparathyroidism undergoing hemodialysis: A randomized, double-blind, placebo-controlled, dose-finding study.

Evocalcet has been developed as a new calcimimetic agent for hemodialysis (HD) patients with secondary hyperparathyroidism (HDSHPT), eliciting fewer gastrointestinal symptoms and drug interactions. We...

Medical and Biotech [MESH] Definitions

A condition of abnormally elevated output of PARATHYROID HORMONE (or PTH) triggering responses that increase blood CALCIUM. It is characterized by HYPERCALCEMIA and BONE RESORPTION, eventually leading to bone diseases. PRIMARY HYPERPARATHYROIDISM is caused by parathyroid HYPERPLASIA or PARATHYROID NEOPLASMS. SECONDARY HYPERPARATHYROIDISM is increased PTH secretion in response to HYPOCALCEMIA, usually caused by chronic KIDNEY DISEASES.

Abnormally elevated PARATHYROID HORMONE secretion as a response to HYPOCALCEMIA. It is caused by chronic KIDNEY FAILURE or other abnormalities in the controls of bone and mineral metabolism, leading to various BONE DISEASES, such as RENAL OSTEODYSTROPHY.

Decalcification of bone or abnormal bone development due to chronic KIDNEY DISEASES, in which 1,25-DIHYDROXYVITAMIN D3 synthesis by the kidneys is impaired, leading to reduced negative feedback on PARATHYROID HORMONE. The resulting SECONDARY HYPERPARATHYROIDISM eventually leads to bone disorders.

Decalcification of bone or abnormal bone development due to chronic KIDNEY DISEASES, in which 1,25-DIHYDROXYVITAMIN D3 synthesis by the kidneys is impaired, leading to reduced negative feedback on PARATHYROID HORMONE. The resulting SECONDARY HYPERPARATHYROIDISM eventually leads to bone disorders.

A fibrous degeneration, cyst formation, and the presence of fibrous nodules in bone, usually due to HYPERPARATHYROIDISM.

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