Effect of Two Iron Preparations on Protein in the Urine

NCT ID: NCT00354692

Last Updated: 2012-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Brief Summary

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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

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Conditions

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Kidney Failure, Chronic Anemia, Iron-Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental

Group Type EXPERIMENTAL

Sodium Ferric Gluconate and Iron sucrose

Intervention Type DRUG

Interventions

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Sodium Ferric Gluconate and Iron sucrose

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Watson Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Adel R. Rizkala, Pharm.D., MS

Role: STUDY_DIRECTOR

Watson Laboratories, Inc.

Locations

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Glendale, California, United States

Site Status

Shreveport, Louisiana, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 17622274 (View on PubMed)

Other Identifiers

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FER0601

Identifier Type: -

Identifier Source: org_study_id