Comparison Between Effects of Two Iron Preparations on Protein in the Urine
NCT ID: NCT00534144
Last Updated: 2011-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
74 participants
INTERVENTIONAL
2007-09-30
2008-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Iron Sucrose
iron sucrose injection, USP
iron sucrose injection, USP, 100 mg intravenously (IV) per week, for 5 weeks
Ferric Gluconate
sodium ferric gluconate complex in sucrose injection
sodium ferric gluconate complex in sucrose injection, 100 mg intravenously (IV) per week, for 5 weeks
Interventions
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iron sucrose injection, USP
iron sucrose injection, USP, 100 mg intravenously (IV) per week, for 5 weeks
sodium ferric gluconate complex in sucrose injection
sodium ferric gluconate complex in sucrose injection, 100 mg intravenously (IV) per week, for 5 weeks
Eligibility Criteria
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Inclusion Criteria
* Iron deficiency
* Moderate to severe chronic kidney disease, not receiving dialysis
* Age ≥ 18 or greater and able to give informed consent
Exclusion Criteria
* Clinically unstable
* Indication of iron sufficiency
* Bladder obstruction conditions that would not allow for good urine output
18 Years
ALL
No
Sponsors
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Watson Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Naomi V. Dahl, Pharm.D.
Role: STUDY_DIRECTOR
Watson Laboratories, Inc.
Locations
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Phoenix, Arizona, United States
Alhambra, California, United States
Bell Gardens, California, United States
Exeter, California, United States
Glendale, California, United States
Visalia, California, United States
Fort Lauderdale, Florida, United States
Hines, Illinois, United States
Shreveport, Louisiana, United States
Boston, Massachusetts, United States
Houston, Texas, United States
Fairfax, Virginia, United States
San Juan, , Puerto Rico
Countries
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References
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Agarwal R, Leehey DJ, Olsen SM, Dahl NV. Proteinuria induced by parenteral iron in chronic kidney disease--a comparative randomized controlled trial. Clin J Am Soc Nephrol. 2011 Jan;6(1):114-21. doi: 10.2215/CJN.06020710. Epub 2010 Sep 28.
Other Identifiers
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FER0701
Identifier Type: -
Identifier Source: org_study_id