Back to resultsEffect of Two Iron Preparations on Protein in the Urine
Primary Purpose
Kidney Failure, Chronic, Anemia, Iron-Deficiency
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Sodium Ferric Gluconate and Iron sucrose
Sponsored by
About this trial
This is an interventional treatment trial for Kidney Failure, Chronic
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental
Arm Description
Outcomes
Primary Outcome Measures
Change in urine protein
Secondary Outcome Measures
Change in various urine chemicals
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00354692
Brief Title
Effect of Two Iron Preparations on Protein in the Urine
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 Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Watson Pharmaceuticals
4. Oversight
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure, Chronic, Anemia, Iron-Deficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Sodium Ferric Gluconate and Iron sucrose
Primary Outcome Measure Information:
Title
Change in urine protein
Time Frame
180 minutes
Secondary Outcome Measure Information:
Title
Change in various urine chemicals
Time Frame
180 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adel R. Rizkala, Pharm.D., MS
Organizational Affiliation
Watson Laboratories, Inc.
Official's Role
Study Director
Facility Information:
City
Glendale
State/Province
California
Country
United States
City
Shreveport
State/Province
Louisiana
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
17622274
Citation
Agarwal R, Rizkala AR, Kaskas MO, Minasian R, Trout JR. Iron sucrose causes greater proteinuria than ferric gluconate in non-dialysis chronic kidney disease. Kidney Int. 2007 Sep;72(5):638-42. doi: 10.1038/sj.ki.5002422. Epub 2007 Jul 11.
Results Reference
result
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Effect of Two Iron Preparations on Protein in the Urine
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