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NCT00354692 Clinical Trial

Effect of Two Iron Preparations on Protein in the Urine

Kidney Failure, Chronic Clinical Trial

Official title:
A Randomized Cross-over Pilot Study of the Effect of Sodium Ferric Gluconate Complex vs. Iron Sucrose on Proteinuria in Non-dialysis Chronic Kidney Disease Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00354692
Other study ID # FER0601
Secondary ID
Status Completed
Phase Phase 4
First received July 18, 2006
Last updated August 10, 2012
Start date June 2006

Study information
Verified date August 2012
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 pilot 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 12
Est. completion date
Est. primary completion date November 2006
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

- Age = 18 or greater and able to give informed consent

Exclusion Criteria:

- Receiving dialysis

- Known sensitivity to Sodium Ferric Gluconate Complex in Sucrose Injection, Iron sucrose USP, or any of their components

- Clinically unstable

- Indication of iron sufficiency

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Sodium Ferric Gluconate and Iron sucrose

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Watson Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & Publications (1)

Agarwal R, Rizkala AR, Kaskas MO, Minasian R, Trout JR. Iron sucrose causes greater proteinuria than ferric gluconate in non-dialysis chronic kidney disease. Kidney Int. 2007 Sep;72(5):638-42. Epub 2007 Jul 11. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Change in urine protein 180 minutes No
Secondary Change in various urine chemicals 180 minutes No
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