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

Watson Pharmaceuticals74 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Kidney Failure, Chronic Anemia, Iron-Deficiency

Interventions

iron sucrose injection, USPDRUG

iron sucrose injection, USP, 100 mg intravenously (IV) per week, for 5 weeks

sodium ferric gluconate complex in sucrose injectionDRUG

sodium ferric gluconate complex in sucrose injection, 100 mg intravenously (IV) per week, for 5 weeks

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Unnamed facility

Phoenix, Arizona, United States

Unnamed facility

Alhambra, California, United States

Unnamed facility

Bell Gardens, California, United States

Unnamed facility

Outcomes

Primary Outcomes

Change in urine protein

Time frame: 6 weeks

Data from ClinicalTrials.gov

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