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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00534144

Enrollment

Registered

2007-09-24

Start date

2007-09-30

Completion date

2008-11-30

Last updated

2011-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Failure, Chronic, Anemia, Iron-Deficiency

Brief summary

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

Interventions

DRUGiron sucrose injection, USP

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

DRUGsodium ferric gluconate complex in sucrose injection

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change in urine protein	6 weeks

Countries

Puerto Rico, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026