Comparison Between Effects of Two Iron Preparations on Protein in the Urine
A Randomized Controlled Trial of the Effect of IV Iron on Proteinuria in Non-Dialysis Chronic Kidney Disease Patients
1 other identifier
interventional
74
2 countries
13
Brief Summary
This study will compare the effects of sodium ferric gluconate complex and iron sucrose on urine concentrations of various chemicals including protein
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Sep 2007
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
September 20, 2007
CompletedFirst Posted
Study publicly available on registry
September 24, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2008
CompletedSeptember 23, 2011
September 1, 2011
1.2 years
September 20, 2007
September 22, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Change in urine protein
6 weeks
Study Arms (2)
Iron Sucrose
ACTIVE COMPARATORFerric Gluconate
ACTIVE COMPARATORInterventions
iron sucrose injection, USP, 100 mg intravenously (IV) per week, for 5 weeks
sodium ferric gluconate complex in sucrose injection, 100 mg intravenously (IV) per week, for 5 weeks
Eligibility Criteria
You may qualify if:
- Moderate to severe anemia
- Iron deficiency
- Moderate to severe chronic kidney disease, not receiving dialysis
- Age ≥ 18 or greater and able to give informed consent
You may not qualify if:
- Known sensitivity to Sodium Ferric Gluconate Complex in Sucrose Injection, Iron sucrose USP, or any of their components
- Clinically unstable
- Indication of iron sufficiency
- Bladder obstruction conditions that would not allow for good urine output
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Unknown Facility
Phoenix, Arizona, United States
Unknown Facility
Alhambra, California, United States
Unknown Facility
Bell Gardens, California, United States
Unknown Facility
Exeter, California, United States
Unknown Facility
Glendale, California, United States
Unknown Facility
Visalia, California, United States
Unknown Facility
Fort Lauderdale, Florida, United States
Unknown Facility
Hines, Illinois, United States
Unknown Facility
Shreveport, Louisiana, United States
Unknown Facility
Boston, Massachusetts, United States
Unknown Facility
Houston, Texas, United States
Unknown Facility
Fairfax, Virginia, United States
Unknown Facility
San Juan, Puerto Rico
Related Publications (1)
Agarwal R, Leehey DJ, Olsen SM, Dahl NV. Proteinuria induced by parenteral iron in chronic kidney disease--a comparative randomized controlled trial. Clin J Am Soc Nephrol. 2011 Jan;6(1):114-21. doi: 10.2215/CJN.06020710. Epub 2010 Sep 28.
PMID: 20876669RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Naomi V. Dahl, Pharm.D.
Watson Laboratories, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 20, 2007
First Posted
September 24, 2007
Study Start
September 1, 2007
Primary Completion
November 1, 2008
Study Completion
November 1, 2008
Last Updated
September 23, 2011
Record last verified: 2011-09