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Comparison Between Effects of Two Iron Preparations on Protein in the Urine

Primary Purpose

Kidney Failure, Chronic, Anemia, Iron-Deficiency

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
iron sucrose injection, USP
sodium ferric gluconate complex in sucrose injection
Sponsored by
Watson Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Kidney Failure, Chronic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Iron Sucrose

Ferric Gluconate

Arm Description

Outcomes

Primary Outcome Measures

Change in urine protein

Secondary Outcome Measures

Full Information

First Posted
September 20, 2007
Last Updated
September 22, 2011
Sponsor
Watson Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00534144
Brief Title
Comparison Between Effects of Two Iron Preparations on Protein in the Urine
Official Title
A Randomized Controlled Trial of the Effect of IV Iron on Proteinuria in Non-Dialysis Chronic Kidney Disease Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Watson Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This 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
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Iron Sucrose
Arm Type
Active Comparator
Arm Title
Ferric Gluconate
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
iron sucrose injection, USP
Intervention Description
iron sucrose injection, USP, 100 mg intravenously (IV) per week, for 5 weeks
Intervention Type
Drug
Intervention Name(s)
sodium ferric gluconate complex in sucrose injection
Intervention Description
sodium ferric gluconate complex in sucrose injection, 100 mg intravenously (IV) per week, for 5 weeks
Primary Outcome Measure Information:
Title
Change in urine protein
Time Frame
6 weeks

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, not receiving dialysis Age ≥ 18 or greater and able to give informed consent Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naomi V. Dahl, Pharm.D.
Organizational Affiliation
Watson Laboratories, Inc.
Official's Role
Study Director
Facility Information:
City
Phoenix
State/Province
Arizona
Country
United States
City
Alhambra
State/Province
California
Country
United States
City
Bell Gardens
State/Province
California
Country
United States
City
Exeter
State/Province
California
Country
United States
City
Glendale
State/Province
California
Country
United States
City
Visalia
State/Province
California
Country
United States
City
Ft Lauderdale
State/Province
Florida
Country
United States
City
Hines
State/Province
Illinois
Country
United States
City
Shreveport
State/Province
Louisiana
Country
United States
City
Boston
State/Province
Massachusetts
Country
United States
City
Houston
State/Province
Texas
Country
United States
City
Fairfax
State/Province
Virginia
Country
United States
City
San Juan
Country
Puerto Rico

12. IPD Sharing Statement

Citations:
PubMed Identifier
20876669
Citation
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.
Results Reference
result

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Comparison Between Effects of Two Iron Preparations on Protein in the Urine

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