We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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
Information provided by (Responsible Party):

Study Description
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

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
Primary Completion Date : November 2006

Arms and Interventions

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

Outcome Measures

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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

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

Responsible Party: Watson Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00354692     History of Changes
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:
Anemia, Iron-Deficiency
Renal Insufficiency
Kidney Failure, Chronic
Anemia, Hypochromic
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Ferric oxide, saccharated
Ferric gluconate
Ferric Compounds
Trace Elements
Growth Substances
Physiological Effects of Drugs