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

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ClinicalTrials.gov Identifier: NCT00223938
Recruitment Status : Terminated (The study was terminated because of significant enrollment challenges)
First Posted : September 22, 2005
Last Update Posted : June 24, 2021
Sponsor:
Information provided by:
Sanofi

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 22, 2005
Last Update Posted Date June 24, 2021
Actual Study Start Date  ICMJE December 30, 2003
Actual Primary Completion Date April 27, 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 18, 2008)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 18, 2008)
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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of the Efficacy and Safety of Ferrlecit in the Maintenance Dosing in Hemodialysis Patients.
Official Title  ICMJE 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.
Brief Summary 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Anemia
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   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 Terminated
Actual Enrollment  ICMJE
 (submitted: June 21, 2021)
112
Original Enrollment  ICMJE
 (submitted: September 13, 2005)
291
Actual Study Completion Date  ICMJE April 27, 2007
Actual Primary Completion Date April 27, 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00223938
Other Study ID Numbers  ICMJE FR02023
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gary Hoel PhD Executive Director, Watson
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Gary Hoel, RPh, PhD Watson Pharmaceuticals
PRS Account Sanofi
Verification Date June 2021

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