Effect of Two Iron Preparations on Protein in the Urine | NCT00354692

Studies
Effect of Two Iron Preparations on Protein in the Urine

NCT00354692

Sponsor

Watson Pharmaceuticals

Status

Completed

Last Update Posted

Aug 14, 2012Estimated

Enrollment

12Actual

Phase

Phase 4

Conditions

Kidney Failure, Chronic
Anemia, Iron-Deficiency

Interventions

Sodium Ferric Gluconate and Iron sucrose

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2006

Primary Completion Date

Nov 2006Actual

Completion Date

Not provided

First Submitted Date

Jul 18, 2006

First Submission Date that Met QC Criteria

Jul 18, 2006

First Posted Date

Jul 20, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 10, 2012

Last Update Posted Date

Aug 14, 2012Estimated

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Label	Type	Description	Intervention Names
Experimental	Experimental		Drug: Sodium Ferric Gluconate and Iron sucrose

Name	Type	Description	Arm Group Labels	Other Names
Sodium Ferric Gluconate and Iron sucrose	Drug		Experimental

Measure	Description	Time Frame
Change in urine protein		180 minutes

Measure	Description	Time Frame
Change in various urine chemicals		180 minutes

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Adel R. Rizkala, Pharm.D., MS	Watson Laboratories, Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Glendale	California		United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17622274	Result	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.

ID	Term
D051436	Renal Insufficiency, Chronic
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases

ID	Term
C035552	ferric gluconate
D000077605	Ferric Oxide, Saccharated

ID	Term
D005290	Ferric Compounds
D058085	Iron Compounds
D007287	Inorganic Chemicals
D005937	Glucaric Acid

ID	Term
D007676	Kidney Failure, Chronic
D018798	Anemia, Iron-Deficiency