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

Phase 1

Completed

• Conditions: Kidney Failure, Chronic; Anemia, Iron-Deficiency
• Interventions: Drug: iron sucrose injection, USP; Drug: sodium ferric gluconate complex in sucrose injection

• Registration Number: NCT00534144
• Lead Sponsor: Watson Pharmaceuticals

Brief Summary

This 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: 2007-09
• Study First Submitted: 2007-09-20
• Study First Submitted QC: 2007-09-20
• Study First Posted: 2007-09-24
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-22
• Last Update Posted: 2011-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Iron Sucrose	iron sucrose injection, USP	-
Ferric Gluconate	sodium ferric gluconate complex in sucrose injection	-

Primary Outcome Measures

Name	Time	Method
Change in urine protein	6 weeks