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Effect of Two Iron Preparations on Protein in the Urine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00354692
Recruitment Status : Completed
First Posted : July 20, 2006
Last Update Posted : August 14, 2012
Sponsor:
Information provided by (Responsible Party):
Watson Pharmaceuticals

Study Description
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Brief Summary:
This pilot 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: Sodium Ferric Gluconate and Iron sucrose Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : June 2006
Actual Primary Completion Date : November 2006

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental Drug: Sodium Ferric Gluconate and Iron sucrose


Outcome Measures
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Primary Outcome Measures :
  1. Change in urine protein [ Time Frame: 180 minutes ]

Secondary Outcome Measures :
  1. Change in various urine chemicals [ Time Frame: 180 minutes ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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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): NCT00354692


Locations
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United States, California
Glendale, California, United States
United States, Louisiana
Shreveport, Louisiana, United States
Sponsors and Collaborators
Watson Pharmaceuticals
Investigators
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Study Director: Adel R. Rizkala, Pharm.D., MS Watson Laboratories, Inc.
More Information
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Publications of Results:

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Responsible Party: Watson Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00354692    
Other Study ID Numbers: FER0601
First Posted: July 20, 2006    Key Record Dates
Last Update Posted: August 14, 2012
Last Verified: August 2012
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Failure, Chronic
Anemia, Iron-Deficiency
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
 Metabolic Diseases
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Ferric Oxide, Saccharated
Ferric gluconate
Hematinics