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

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ClinicalTrials.gov Identifier: NCT00534144
Recruitment Status : Completed
First Posted : September 24, 2007
Last Update Posted : September 23, 2011
Sponsor:
Information provided by (Responsible Party):
Watson Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Kidney Failure, Chronic Anemia, Iron-Deficiency Drug: iron sucrose injection, USP Drug: sodium ferric gluconate complex in sucrose injection Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Randomized Controlled Trial of the Effect of IV Iron on Proteinuria in Non-Dialysis Chronic Kidney Disease Patients
Study Start Date : September 2007
Actual Primary Completion Date : November 2008
Actual Study Completion Date : November 2008


Arm Intervention/treatment
Active Comparator: Iron Sucrose Drug: iron sucrose injection, USP
iron sucrose injection, USP, 100 mg intravenously (IV) per week, for 5 weeks
Active Comparator: Ferric Gluconate Drug: sodium ferric gluconate complex in sucrose injection
sodium ferric gluconate complex in sucrose injection, 100 mg intravenously (IV) per week, for 5 weeks



Primary Outcome Measures :
  1. Change in urine protein [ Time Frame: 6 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00534144


Locations
United States, Arizona
Phoenix, Arizona, United States
United States, California
Alhambra, California, United States
Bell Gardens, California, United States
Exeter, California, United States
Glendale, California, United States
Visalia, California, United States
United States, Florida
Ft Lauderdale, Florida, United States
United States, Illinois
Hines, Illinois, United States
United States, Louisiana
Shreveport, Louisiana, United States
United States, Massachusetts
Boston, Massachusetts, United States
United States, Texas
Houston, Texas, United States
United States, Virginia
Fairfax, Virginia, United States
Puerto Rico
San Juan, Puerto Rico
Sponsors and Collaborators
Watson Pharmaceuticals
Investigators
Study Director: Naomi V. Dahl, Pharm.D. Watson Laboratories, Inc.

Publications of Results:
Responsible Party: Watson Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00534144     History of Changes
Other Study ID Numbers: FER0701
First Posted: September 24, 2007    Key Record Dates
Last Update Posted: September 23, 2011
Last Verified: September 2011

Additional relevant MeSH terms:
Anemia, Iron-Deficiency
Renal Insufficiency
Kidney Failure, Chronic
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Iron
Ferric oxide, saccharated
Ferric gluconate
Ferric Compounds
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Hematinics