Effect of Two Iron Preparations on Protein in the Urine - Full Text View

Sponsored by:	Watson Pharmaceuticals
Information provided by:	Watson Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00354692

Purpose

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

Condition	Intervention	Phase
Kidney Failure, Chronic Anemia, Iron-Deficiency	Drug: Sodium Ferric Gluconate and Iron sucrose	Phase IV

MedlinePlus related topics: Anemia Dietary Sodium Kidney Failure Urine and Urination

Drug Information available for: Sucrose Sodium ferric gluconate complex D-Gluconic acid, monosodium salt Gluconic acid Manganese gluconate Ferric oxide, saccharated

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Open Label, Active Control, Crossover Assignment
Official 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

Further study details as provided by Watson Pharmaceuticals:

Primary Outcome Measures:

Change in urine protein

Secondary Outcome Measures:

Change in various urine chemicals

Estimated Enrollment:	12
Study Start Date:	June 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00354692

Locations

United States, California

Glendale, California, United States
United States, Louisiana

Shreveport, Louisiana, United States

Sponsors and Collaborators

Watson Pharmaceuticals

Investigators

Study Director:

Adel R. Rizkala, Pharm.D., MS

Watson Laboratories, Inc.

More Information

Publications of Results:

Agarwal R, Rizkala AR, Kaskas MO, Minasian R, Trout JR. Iron sucrose causes greater proteinuria than ferric gluconate in non-dialysis chronic kidney disease. Kidney Int. 2007 Sep;72(5):638-42. Epub 2007 Jul 11.

Study ID Numbers:	FER0601
Study First Received:	July 18, 2006
Last Updated:	September 10, 2007
ClinicalTrials.gov Identifier:	NCT00354692
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Renal Insufficiency
Metabolic Diseases
Hematologic Diseases
Kidney Failure, Chronic
Anemia
Iron Metabolism Disorders
Anemia, Iron-Deficiency
Ferric oxide, saccharated

Proteinuria
Urologic Diseases
Renal Insufficiency, Chronic
Ferric gluconate
Kidney Diseases
Metabolic disorder
Iron
Kidney Failure

Additional relevant MeSH terms:

Hematinics
Therapeutic Uses
Hematologic Agents
Anemia, Hypochromic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009