Effect of Two Iron Preparations on Protein in the Urine

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

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Key information

Conditions

Kidney Failure, Chronic Anemia Anemia, Hypochromic Anemia, Iron-Deficiency Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hematologic Diseases Hemic and Lymphatic Diseases Iron Deficiencies Iron Metabolism Disorders Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Glendale, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sodium Ferric Gluconate and Iron sucrose

Drug

Primary outcomes

Change in urine protein

Time frame: 180 minutes

Secondary outcomes

Change in various urine chemicals

Time frame: 180 minutes

Sponsors and collaborators

Lead sponsor

Watson Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start: 2006
Primary completion: 2006
First posted: Jul 20, 2006
Registry last updated: Aug 14, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed