Effect of Two Iron Preparations on Protein in the Urine

Phase 4

Completed

• Conditions: Kidney Failure, Chronic; Anemia, Iron-Deficiency
• Interventions: Drug: Sodium Ferric Gluconate and Iron sucrose

• Registration Number: NCT00354692
• Lead Sponsor: Watson Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2006-07-18
• Study First Submitted QC: 2006-07-18
• Study First Posted: 2006-07-20
• Primary Completion: 2006-11
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-10
• Last Update Posted: 2012-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Experimental	Sodium Ferric Gluconate and Iron sucrose	-

Primary Outcome Measures

Name	Time	Method
Change in urine protein	180 minutes

Secondary Outcome Measures

Name	Time	Method
Change in various urine chemicals	180 minutes