Document Detail


Lanthanum carbonate reduces phosphorus burden in patients with CKD stages 3 and 4: a randomized trial.
MedLine Citation:
PMID:  19056618     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND AND OBJECTIVES: Lanthanum carbonate (FOSRENOL, Shire Pharmaceuticals) is an effective noncalcium, nonresin phosphate binder for the control of hyperphosphatemia in chronic kidney disease (CKD) stage 5 patients undergoing dialysis.
DESIGN, SETTING, PARTICIPANTS AND MEASUREMENTS: A Phase 2, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of lanthanum carbonate in CKD stage 3 and 4 patients. Of 281 patients screened, 121 were randomized (2:1) to lanthanum carbonate or placebo (80 versus 41). The modified intent-to-treat population included 90 patients (56 versus 34); 71 (43 versus 28) completed the study. After run-in, when any current phosphate binders were discontinued and dietary counseling reinforced, patients with serum phosphorus >4.6 mg/dl received lanthanum carbonate (titrated up to 3000 mg/d) or matching placebo for 8 wk.
RESULTS: At the end of treatment, 25 (44.6%) versus nine (26.5%) patients had serum phosphorus < or =4.6 mg/dl (difference 18.1%, P = 0.12) in the lanthanum carbonate and placebo groups, respectively. Statistically significant differences were observed between groups in change from baseline to end of treatment for serum phosphorus (P = 0.02), intact parathyroid hormone (P = 0.02), and urinary phosphorus excretion (P = 0.04). The safety profile and tolerability of lanthanum carbonate were similar to that of placebo.
CONCLUSIONS: Because <1% of phosphorus is in the extracellular fluid, serum measurements may not accurately reflect total body burden in patients with CKD stages 3 and 4. However, lanthanum carbonate is an effective phosphate binder in this patient population, with a safety profile and tolerability similar to that of placebo.
Authors:
Stuart M Sprague; Hanna Abboud; Ping Qiu; Matthew Dauphin; Pinggao Zhang; William Finn
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Publication Detail:
Type:  Clinical Trial, Phase II; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2008-12-03
Journal Detail:
Title:  Clinical journal of the American Society of Nephrology : CJASN     Volume:  4     ISSN:  1555-905X     ISO Abbreviation:  Clin J Am Soc Nephrol     Publication Date:  2009 Jan 
Date Detail:
Created Date:  2009-01-14     Completed Date:  2009-04-10     Revised Date:  2012-09-10    
Medline Journal Info:
Nlm Unique ID:  101271570     Medline TA:  Clin J Am Soc Nephrol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  178-85     Citation Subset:  IM    
Affiliation:
Northwestern University Feinberg School of Medicine, Evanston Northwestern Healthcare, Evanston, IL 60201, USA. ssprague@northwestern.edu
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00234702
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MeSH Terms
Descriptor/Qualifier:
Adult
Aged
Aged, 80 and over
Chronic Disease
Double-Blind Method
Female
Humans
Hyperphosphatemia / blood,  drug therapy*,  etiology
Kidney Diseases / complications,  therapy*
Lanthanum / adverse effects,  therapeutic use*
Male
Middle Aged
Parathyroid Hormone / blood
Phosphorus / blood*,  urine
Renal Dialysis*
Severity of Illness Index
Time Factors
Treatment Outcome
Chemical
Reg. No./Substance:
0/Parathyroid Hormone; 0/lanthanum carbonate; 7439-91-0/Lanthanum; 7723-14-0/Phosphorus
Comments/Corrections

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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