Pharmacodynamic Study of Two Lanthanum Carbonate Formulations in Healthy Adults
Summary
This study is being conducted to assess any potential differences in the absorption and excretion between two lanthanum carbonate formulations. This study is also being done to assess the safety and tolerability of the two lanthanum carbonate formulations.
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label
Conditions
End Stage Renal Disease
Intervention
Lanthanum carbonate Granule Formulation, Lanthanum carbonate Chewable Tablets (Fosrenol)
Location
West Coast Clinical Trials, LLC
Cypress
California
United States
90630
Status
Completed
Source
Shire Pharmaceutical Development
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00880750
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Lanthanum
Lanthanum. The prototypical element in the rare earth family of metals. It has the atomic symbol La, atomic number 57, and atomic weight 138.91. Lanthanide ion is used in experimental biology as a calcium antagonist; lanthanum oxide improves the optical properties of glass.
Chemistry, Inorganic
A field of chemistry which pertains to chemical compounds or ions that do not contain the element carbon (with the exception of carbon dioxide and compounds containing a carbonate radical, e.g., calcium carbonate).
Lanthanoid Series Elements
Elements of the lanthanoid series including atomic number 57 (LANTHANUM) through atomic number 71 (LUTETIUM).
Calcium Carbonate
Carbonic acid calcium salt (CaCO3). An odorless, tasteless powder or crystal that occurs in nature. It is used therapeutically as a phosphate buffer in hemodialysis patients and as a calcium supplement.
Lithium Carbonate
A lithium salt, classified as a mood-stabilizing agent. Lithium ion alters the metabolism of BIOGENIC MONOAMINES in the CENTRAL NERVOUS SYSTEM, and affects multiple neurotransmission systems.
Clinical Trials
The purpose of this study is to assess the safety of lanthanum carbonate in patients undergoing dialysis who have received lanthanum carbonate in the previous studies and wish to continue...
Chewed vs. Crushed Lanthanum Carbonate in Hemodialysis Patients
Patients with end-stage renal disease (ESRD) commonly develop hyperphosphatemia due to the loss of excretory function of the kidney. This in turn may lead to the development of secondary h...
The purpose of this study is to demonstrate decrease in cardiovascular mortality and morbidity in Japanese hemodialysis patients treated with Lanthanum carbonate compared with those with C...
The purpose of this study is to assess phosphate reduction and control in patients with End Stage Renal Disease treated with lanthanum carbonate
The purpose of this study is to assess phosphate reduction and control in patients with End Stage Renal Disease treated with either lanthanum carbonate or sevelamer hydrochloride
PubMed Articles
In vitro bioequivalence approach for a locally acting gastrointestinal drug: lanthanum carbonate.
A conventional human pharmacokinetic (PK) in vivo study is often considered as the "gold standard" to determine bioequivalence (BE) of drug products. However, this BE approach is not always applicable...
Background: Recent publications show that elevation of FGF23 is independently associated with progression or renal disease, left ventricular hypertrophy and cardiovascular mortality. Dietary restricti...
Signal intensity of lanthanum carbonate on magnetic resonance images: phantom study.
Lanthanum carbonate (LC) is used to treat hyperphosphatemia. The purpose of this study was to investigate the signal intensity (SI) of LC on magnetic resonance imaging (MRI) scans of phantoms.
Radio-opaque fecal impaction and pseudo-occlusion in a dialyzed patient taking lanthanum carbonate.
Lanthanum therapy is an efficient therapy of hyperphosphoremia by chelating phosphore in the digestive tract. Lanthanum is a silvery white metallic element that belongs to group 3 of the periodic tabl...
Background/Aims: Dual energy X-ray absorptiometry (DEXA) scanning is used to assess bone mineral content and diagnose osteoporosis. We had noted anecdotal cases of patients attending for DEXA scanning...
