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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Watson Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00534144
First received: September 20, 2007
Last updated: September 22, 2011
Last verified: September 2011
History of Changes
  Purpose

This 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: iron sucrose injection, USP
Drug: sodium ferric gluconate complex in sucrose injection
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Watson Pharmaceuticals:

Primary Outcome Measures:
  • Change in urine protein [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 74
Study Start Date: September 2007
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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.
  More Information

Publications:

Responsible Party: Watson Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00534144     History of Changes
Other Study ID Numbers: FER0701
Study First Received: September 20, 2007
Last Updated: September 22, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 16, 2013