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Effect of Two Iron Preparations on Protein in the Urine

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00354692
First Posted: July 20, 2006
Last Update Posted: August 14, 2012
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.
Information provided by (Responsible Party):
Watson Pharmaceuticals
  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 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Watson Pharmaceuticals:

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

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

Enrollment: 12
Study Start Date: June 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental Drug: Sodium Ferric Gluconate and Iron sucrose

  Eligibility

Information from the National Library of Medicine

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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
  • 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
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
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:
Responsible Party: Watson Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00354692     History of Changes
Other Study ID Numbers: FER0601
First Submitted: July 18, 2006
First Posted: July 20, 2006
Last Update Posted: August 14, 2012
Last Verified: August 2012

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