Document Detail


Oral paricalcitol in the treatment of patients with CKD and proteinuria: a randomized trial.
MedLine Citation:
PMID:  19596163     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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. STUDY DESIGN: Double-blind randomized study. SETTING & PARTICIPANTS: 61 patients with estimated glomerular filtration rate of 15 to 90 mL/min/1.73 m(2) and protein excretion greater than 400 mg/24 h. INTERVENTION: Randomization to 6 months of treatment with paricalcitol, 1 mug/d, or placebo. OUTCOMES & MEASUREMENTS: The predefined primary end point was to compare change in mean spot urinary protein-creatinine ratio between the baseline measurement and the last study evaluation (6 months in study completers) between the 2 groups. Every 4 weeks, there was measurement of serum intact parathyroid hormone, serum calcium, serum phosphorus, serum creatinine, and urine spot protein and creatinine. RESULTS: At baseline, mean urinary protein-creatinine ratios were 2.6 and 2.8 g/g in the placebo and paricalcitol groups, respectively. At final evaluation, mean ratios were 2.7 and 2.3, respectively. Changes in protein excretion from baseline to last evaluation were +2.9% for controls and -17.6% for the paricalcitol group (P = 0.04). A 10% decrease in proteinuria occurred in controls (7 of 27; 25.9%) and the paricalcitol group (16 of 28; 57.1%; P = 0.03). LIMITATIONS: The relatively small sample size limits the extent to which results should be generalized. CONCLUSIONS: Paricalcitol resulted in a significant reduction in protein excretion in patients with proteinuric renal disease.
Authors:
Steven Fishbane; Harini Chittineni; Michal Packman; Paula Dutka; Nicole Ali; Nicole Durie
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Publication Detail:
Type:  Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2009-07-12
Journal Detail:
Title:  American journal of kidney diseases : the official journal of the National Kidney Foundation     Volume:  54     ISSN:  1523-6838     ISO Abbreviation:  Am. J. Kidney Dis.     Publication Date:  2009 Oct 
Date Detail:
Created Date:  2009-09-28     Completed Date:  2009-10-02     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8110075     Medline TA:  Am J Kidney Dis     Country:  United States    
Other Details:
Languages:  eng     Pagination:  647-52     Citation Subset:  IM    
Affiliation:
Winthrop-University Hospital, Mineola, NY, USA. sfishbane@metrorenal.com
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00469625
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MeSH Terms
Descriptor/Qualifier:
Administration, Oral
Adult
Aged
Biological Markers / blood
Bone Density Conservation Agents / administration & dosage,  therapeutic use*
Calcium / blood
Creatinine / blood,  urine
Double-Blind Method
Ergocalciferols / administration & dosage,  therapeutic use*
Female
Glomerular Filtration Rate / drug effects
Humans
Male
Middle Aged
Parathyroid Hormone / blood
Phosphorus / blood
Proteinuria / blood,  drug therapy*,  etiology,  physiopathology
Renal Insufficiency, Chronic / blood,  complications*,  drug therapy*,  physiopathology
Sample Size
Treatment Outcome
Vitamin D Deficiency / blood,  complications*,  drug therapy*,  physiopathology
Chemical
Reg. No./Substance:
0/Biological Markers; 0/Bone Density Conservation Agents; 0/Ergocalciferols; 0/Parathyroid Hormone; 131918-61-1/paricalcitol; 60-27-5/Creatinine; 7440-70-2/Calcium; 7723-14-0/Phosphorus

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


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