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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 : Unknown
Verified February 2008 by Watson Pharmaceuticals.
Recruitment status was:  Active, not recruiting
First Posted : September 22, 2005
Last Update Posted : February 22, 2008
Sponsor:
Information provided by:
Watson Pharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Anemia Drug: Oral Iron Drug: sodium ferric gluconate Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 291 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : May 2004
Estimated Primary Completion Date : September 2009
Estimated Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis Iron

Arm Intervention/treatment
Active Comparator: 1
Oral Iron
Drug: Oral Iron
Oral Iron
Other Name: Ferrous sulfate

Experimental: 2
sodium ferric gluconate
Drug: sodium ferric gluconate
weekly intravenous injection Dose 1
Other Name: Ferrlecit

Experimental: 3
sodium ferric gluconate
Drug: sodium ferric gluconate
weekly intravenous injection Dose 2
Other Name: Ferrlecit




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00223938


Locations
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United States, Arkansas
Hot Springs, Arkansas, United States
United States, California
Orange County, California, United States
Simi Valley, California, United States
United States, Florida
Pembroke Pines, Florida, United States
United States, North Carolina
Winston-Salem, North Carolina, United States
United States, Ohio
Canton, Ohio, United States
Columbus, Ohio, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
Sponsors and Collaborators
Watson Pharmaceuticals
Investigators
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Study Director: Gary Hoel, RPh, PhD Watson Pharmaceuticals

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Responsible Party: Gary Hoel PhD Executive Director, Watson
ClinicalTrials.gov Identifier: NCT00223938     History of Changes
Other Study ID Numbers: FR02023
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: February 22, 2008
Last Verified: February 2008

Additional relevant MeSH terms:
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Iron
Ferric gluconate
Ferric Compounds
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Hematinics