Study of the Efficacy and Safety of Ferrlecit in the Maintenance Dosing in Hemodialysis Patients.
Information source: Watson Pharmaceuticals
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Anemia
Intervention: Oral Iron (Drug); sodium ferric gluconate (Drug); sodium ferric gluconate (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Watson Pharmaceuticals Official(s) and/or principal investigator(s):
Gary Hoel, RPh, PhD, Study Director, Affiliation: Watson Pharmaceuticals
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.
Clinical Details
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 design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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.
Secondary outcome: 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.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Hot Springs, Arkansas, United States
Simi Valley, California, United States
Orange County, California, United States
Pembroke Pines, Florida, United States
Winston-Salem, North Carolina, United States
Columbus, Ohio, United States
Canton, Ohio, United States
Philadelphia, Pennsylvania, United States
Additional Information
Starting date: May 2004
Ending date: September 2009
Last updated: February 18, 2008
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