Status:
TERMINATED
Study of the Efficacy and Safety of Ferrlecit in the Maintenance Dosing in Hemodialysis Patients.
Lead Sponsor:
Sanofi
Conditions:
Anemia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 Erythro...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 30 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 27 2007
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT00223938
Start Date
December 30 2003
End Date
April 27 2007
Last Update
June 24 2021
Active Locations (8)
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1
Hot Springs, Arkansas, United States
2
Orange County, California, United States
3
Simi Valley, California, United States
4
Pembroke Pines, Florida, United States