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

This 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 1

Primary location

San Juan, Puerto Rico

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, 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

Treatment and study plan

iron sucrose injection, USP

Drug

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

sodium ferric gluconate complex in sucrose injection

Drug

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

Primary outcomes

Change in urine protein

Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Watson Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start: 2007
Primary completion: 2008
Study completion: 2008
First posted: Sep 24, 2007
Registry last updated: Sep 23, 2011

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