NCT00354692

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

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

June 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 18, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 20, 2006

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
Last Updated

August 14, 2012

Status Verified

August 1, 2012

Enrollment Period

5 months

First QC Date

July 18, 2006

Last Update Submit

August 10, 2012

Conditions

Kidney Failure, ChronicAnemia, Iron-Deficiency

Outcome Measures

Primary Outcomes (1)

  • Change in urine protein

    180 minutes

Secondary Outcomes (1)

  • Change in various urine chemicals

    180 minutes

Study Arms (1)

Experimental

EXPERIMENTAL
Drug: Sodium Ferric Gluconate and Iron sucrose

Interventions

Sodium Ferric Gluconate and Iron sucroseDRUG
Experimental

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Moderate to severe anemia
  • Iron deficiency
  • Moderate to severe chronic kidney disease
  • Age ≥ 18 or greater and able to give informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Glendale, California, United States

Location

Unknown Facility

Shreveport, Louisiana, United States

Location

Related Publications (1)

  • 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.

    PMID: 17622274RESULT

MeSH Terms

Conditions

Kidney Failure, ChronicAnemia, Iron-Deficiency

Interventions

ferric gluconateFerric Oxide, Saccharated

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsAnemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Ferric CompoundsIron CompoundsInorganic ChemicalsGlucaric AcidSugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydrates

Study Officials

  • Adel R. Rizkala, Pharm.D., MS

    Watson Laboratories, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2006

First Posted

July 20, 2006

Study Start

June 1, 2006

Primary Completion

November 1, 2006

Last Updated

August 14, 2012

Record last verified: 2012-08

Locations

US(2)