DRIVE Trial (Dialysis Patients' Response to Intravenous [IV] Iron With Elevated Ferritin)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Watson Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00224081

First received: September 13, 2005

Last updated: November 29, 2011

Last verified: September 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

November 29, 2011

Start Date ^ICMJE

September 2004

Primary Completion Date

May 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change in hemoglobin and anemia medications [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Change in hemoglobin

Change History

Complete list of historical versions of study NCT00224081 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change in various iron indices [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Change in various iron indices

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

DRIVE Trial (Dialysis Patients' Response to Intravenous [IV] Iron With Elevated Ferritin)

Official Title ^ICMJE

Dialysis Patients' Response to IV Iron With Elevated Ferritin

Brief Summary

This study explores the safety and efficacy of intravenous iron therapy in anemic hemodialysis patients treated with epoetin alfa, who have higher serum ferritin levels, but low to normal transferrin saturation.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Anemia, Iron-Deficiency
Kidney Failure, Chronic
Hemodialysis

Intervention ^ICMJE

Drug: Sodium ferric gluconate,

Sodium ferric gluconate, 125 mg IV given at 8 consecutive hemodialysis sessions

Study Arm (s)

Experimental: Ferric gluconate
Intervention: Drug: Sodium ferric gluconate,
No Intervention: standard of care
Intervention: Drug: Sodium ferric gluconate,

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

134

Completion Date

Not Provided

Primary Completion Date

May 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Chronic hemodialysis
Elevated serum ferritin with low to normal transferrin saturation (TSAT)
Moderate to severe anemia
Receiving epoetin alfa treatment

Exclusion Criteria:

Known sensitivity to Ferrlecit®
Medical conditions that would confound the efficacy evaluation
Recent blood transfusion

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00224081

Other Study ID Numbers ^ICMJE

FER0401

Has Data Monitoring Committee

Not Provided

Responsible Party

Watson Pharmaceuticals

Study Sponsor ^ICMJE

Watson Pharmaceuticals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Adel R. Rizkala, Pharm.D., MS

Watson Laboratories, Inc.

Information Provided By

Watson Pharmaceuticals

Verification Date

September 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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