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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00223938 |
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Date of registration:
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13/09/2005 |
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Primary sponsor: |
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Public title:
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Study of the Efficacy and Safety of Ferrlecit in the Maintenance Dosing in Hemodialysis Patients.
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Scientific title:
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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. |
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Date of first enrolment:
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May 2004 |
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Target sample size:
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291 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00223938 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Gary Hoel, RPh, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Watson Pharmaceuticals |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Anemia
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Intervention(s)
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Drug: Oral Iron
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Drug: sodium ferric gluconate
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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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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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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