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Study of the Efficacy and Safety of Ferrlecit in the Maintenance Dosing in Hemodialysis Patients.

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2008 by Watson Pharmaceuticals.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Watson Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00223938
First received: September 13, 2005
Last updated: February 18, 2008
Last verified: February 2008
History of Changes

September 13, 2005
February 18, 2008
May 2004
September 2009   (final data collection date for primary outcome measure)
The primary objective of this study is to evaluate the efficacy of two dose levels of Ferrlecit when compared with oral iron when administered as maintenance therapy in iron-replete hemodialysis patients who are receiving Erythropoietin. [ Time Frame: 22 weeks ] [ Designated as safety issue: No ]
The primary objective of this study is to evaluate the efficacy of two dose levels of Ferrlecit when compared with oral iron when administered as maintenance therapy in iron-replete hemodialysis patients who are receiving Erythropoietin.
Complete list of historical versions of study NCT00223938 on ClinicalTrials.gov Archive Site
The secondary objectives of this study include comparisons between Ferrlecit treatments to oral iron regarding changes from baseline in hematological parameters, iron indices, EPO requirements and safety. [ Time Frame: 22 weeks ] [ Designated as safety issue: No ]
The secondary objectives of this study include comparisons between Ferrlecit treatments to oral iron regarding changes from baseline in hematological parameters, iron indices, EPO requirements and safety.
Not Provided
Not Provided
 
Study of the Efficacy and Safety of Ferrlecit in the Maintenance Dosing in Hemodialysis Patients.
A Multi-Center, Open-Label, Randomized, Parallel Group Study of the Efficacy and Safety of Ferrlecit in the Maintenance of Iron Stores and Serum Hemoglobin Concentration in Hemodialysis Patients Receiving Erythropoietin.

This is a phase 4 clinical investigation of the efficacy and safety of Ferrlecit in the maintenance of iron stores and serum hemoglobin concentration in hemodialysis patients receiving Erythropoietin.

A Multi-Center, Open-Label, Parallel Group Study of the efficacy and safety of Ferrlecit in the Maintenance of Iron Stores and Serum Hemoglobin Concentration in Hemodialysis Patients Receiving Erythropoietin. Patients with normal iron indices receive one of two doses of Ferrlecit administered weekly throughout the treatment period. Efficacy was assesses at designated timepoints throughout the study and after the last Ferrlecit dose.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Anemia
  • Drug: Oral Iron
    Oral Iron
    Other Name: Ferrous sulfate
  • Drug: sodium ferric gluconate
    weekly intravenous injection Dose 1
    Other Name: Ferrlecit
  • Drug: sodium ferric gluconate
    weekly intravenous injection Dose 2
    Other Name: Ferrlecit
  • Active Comparator: 1
    Oral Iron
    Intervention: Drug: Oral Iron
  • Experimental: 2
    sodium ferric gluconate
    Intervention: Drug: sodium ferric gluconate
  • Experimental: 3
    sodium ferric gluconate
    Intervention: Drug: sodium ferric gluconate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
291
September 2009
September 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male of female, 18 years old or older.
  • Have been receiving chronic hemodialysis therapy
  • On stable EPO dosing regimen.
  • Have signed patient informed consent.
  • Predetermined serum ferritin and TSAT levels.
  • Clinical instability - inability to achieve adequate dialysis, abnormal serum albumin and serum glucose.
  • Pregnant or lactating.
  • A known sensitivity to Ferrlecit

Exclusion Criteria:

  • Scheduled for renal transplant.
  • A serious concomitant medical disorders incompatible with participation in the study.
  • Unable to cooperate or comply with the protocol.
  • Use of any investigation agent within 30 days prior to study or during the course of the study.
  • Judged by the investigator as unsuitable for enrollment for any reason.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00223938
FR02023
No
Gary Hoel PhD Executive Director, Watson
Watson Pharmaceuticals
Not Provided
Study Director: Gary Hoel, RPh, PhD Watson Pharmaceuticals
Watson Pharmaceuticals
February 2008

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