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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Anemia, Iron-Deficiency Anemia Anemia, Hypochromic Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hematologic Diseases Hemic and Lymphatic Diseases Hemodialysis Iron Deficiencies Iron Metabolism Disorders Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Bakersfield, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sodium ferric gluconate,

Drug

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

Primary outcomes

Change in hemoglobin and anemia medications

Time frame: 6 weeks

Secondary outcomes

Change in various iron indices

Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Watson Pharmaceuticals

Industry

Registry information

Official study title

Dialysis Patients' Response to IV Iron With Elevated Ferritin

Acronym: DRIVE

Important dates

Study start: 2004
Primary completion: 2006
First posted: Sep 22, 2005
Registry last updated: Dec 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed