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Effect 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:
NCT00354692
First received: July 18, 2006
Last updated: August 10, 2012
Last verified: August 2012
History of Changes
  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: 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:

U.S. FDA Resources

Further study details as provided by Watson Pharmaceuticals:

Primary Outcome Measures:
  • Change in urine protein [ Time Frame: 180 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in various urine chemicals [ Time Frame: 180 minutes ] [ Designated as safety issue: No ]

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

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
  • 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:

Responsible Party: Watson Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00354692     History of Changes
Other Study ID Numbers: FER0601
Study First Received: July 18, 2006
Last Updated: August 10, 2012
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 19, 2013