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Effect of Two Iron Preparations on Protein in the Urine

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00354692
Enrollment
12
Registered
2006-07-20
Start date
2006-06-30
Completion date
Unknown
Last updated
2012-08-14

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

Conditions

Anemia, Iron-Deficiency, Kidney Failure, Chronic

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

Interventions

DRUGSodium Ferric Gluconate and Iron sucrose

Sponsors

Watson Pharmaceuticals
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Change in urine protein180 minutes

Secondary

MeasureTime frame
Change in various urine chemicals180 minutes

Countries

United States

Outcome results

None listed

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