Comparison Between Effects of Two Iron Preparations on Protein in the Urine

NCT00534144 — Phase 1, Completed, 74 participants, Watson Pharmaceuticals
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A Randomized Controlled Trial of the Effect of IV Iron on Proteinuria in Non-Dialysis Chronic Kidney Disease Patients

RegistryNCT00534144
StatusCompleted
PhasePhase 1
Study typeInterventional; randomized, parallel, masking: none, basic science
Enrollment74 (Actual)
SponsorWatson Pharmaceuticals (Industry)
ConditionsKidney Failure, Chronic, Anemia, Iron-Deficiency
Interventionsiron sucrose injection, USP, sodium ferric gluconate complex in sucrose injection (Drug)
Datesstart 2007-09-01, primary completion 2008-11-01, completion 2008-11-01, first posted 2007-09-24, last updated 2011-09-23
Locations13 sites in United States, Puerto Rico

Related Papers Related Patents Related Grants Related Experts
All trials for Kidney Failure, Chronic All trials for Anemia, Iron-Deficiency All trials of iron sucrose injection, USP All trials of sodium ferric gluconate complex in sucrose injection

-Summary

This study will compare the effects of sodium ferric gluconate complex and iron sucrose on urine concentrations of various chemicals including protein

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+Arms and interventions

ArmTypeInterventionsDescription
Iron SucroseActive comparatorDrug: iron sucrose injection, USP
Ferric GluconateActive comparatorDrug: sodium ferric gluconate complex in sucrose injection
  • iron sucrose injection, USP (Drug): iron sucrose injection, USP, 100 mg intravenously (IV) per week, for 5 weeks
  • sodium ferric gluconate complex in sucrose injection (Drug): sodium ferric gluconate complex in sucrose injection, 100 mg intravenously (IV) per week, for 5 weeks

+Outcome measures

Primary outcomes

  • Change in urine protein [6 weeks]

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Moderate to severe anemia
* Iron deficiency
* Moderate to severe chronic kidney disease, not receiving dialysis
* Age ≥ 18 or greater and able to give informed consent

Exclusion Criteria:

* Known sensitivity to Sodium Ferric Gluconate Complex in Sucrose Injection, Iron sucrose USP, or any of their components
* Clinically unstable
* Indication of iron sufficiency
* Bladder obstruction conditions that would not allow for good urine output

+Locations (13)

FacilityCityCountryStatus
Phoenix, ArizonaUnited States
Alhambra, CaliforniaUnited States
Bell Gardens, CaliforniaUnited States
Exeter, CaliforniaUnited States
Glendale, CaliforniaUnited States
Visalia, CaliforniaUnited States
Fort Lauderdale, FloridaUnited States
Hines, IllinoisUnited States
Shreveport, LouisianaUnited States
Boston, MassachusettsUnited States
Houston, TexasUnited States
Fairfax, VirginiaUnited States
San JuanPuerto Rico

+Publications

  • Results publication: 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. PMID 20876669

+Investigators