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NCT00534144 Clinical Trial

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

Kidney Failure, Chronic Clinical Trial

Official title:
A Randomized Controlled Trial of the Effect of IV Iron on Proteinuria in Non-Dialysis Chronic Kidney Disease Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00534144
Other study ID # FER0701
Secondary ID
Status Completed
Phase Phase 1
First received September 20, 2007
Last updated September 22, 2011
Start date September 2007
Est. completion date November 2008

Study information
Verified date September 2011
Source Watson Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 74
Est. completion date November 2008
Est. primary completion date November 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

Drug:
• 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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Watson Pharmaceuticals

Countries where clinical trial is conducted

United States,  Puerto Rico, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Change in urine protein 6 weeks No
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