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

Hemodialysis Clinical Trial

— DRIVE  

Official title:

Dialysis Patients' Response to IV Iron With Elevated Ferritin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00224081
• Other study ID #: FER0401
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: December 8, 2015
• Start date: September 2004

Study information

• Verified date: December 2015
• Source: Watson Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Hemodialysis
• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Watson Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & Publications (4)

Coyne DW, Kapoian T, Suki W, Singh AK, Moran JE, Dahl NV, Rizkala AR; DRIVE Study Group. Ferric gluconate is highly efficacious in anemic hemodialysis patients with high serum ferritin and low transferrin saturation: results of the Dialysis Patients' Resp — View Citation

Kapoian T, O'Mara NB, Singh AK, Moran J, Rizkala AR, Geronemus R, Kopelman RC, Dahl NV, Coyne DW. Ferric gluconate reduces epoetin requirements in hemodialysis patients with elevated ferritin. J Am Soc Nephrol. 2008 Feb;19(2):372-9. doi: 10.1681/ASN.20070 — View Citation

Pizzi LT, Bunz TJ, Coyne DW, Goldfarb DS, Singh AK. Ferric gluconate treatment provides cost savings in patients with high ferritin and low transferrin saturation. Kidney Int. 2008 Dec;74(12):1588-95. doi: 10.1038/ki.2008.489. Epub 2008 Oct 1. — View Citation

Singh AK, Coyne DW, Shapiro W, Rizkala AR; DRIVE Study Group. Predictors of the response to treatment in anemic hemodialysis patients with high serum ferritin and low transferrin saturation. Kidney Int. 2007 Jun;71(11):1163-71. Epub 2007 Mar 28. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in hemoglobin and anemia medications		6 weeks	No
Secondary	Change in various iron indices		6 weeks	No