Study of the Efficacy and Safety of Ferrlecit in the Maintenance Dosing in Hemodialysis Patients.
This trial is active, not recruiting.
|Treatments||oral iron, sodium ferric gluconate|
|Start date||May 2004|
|End date||September 2009|
|Trial size||291 participants|
|Trial identifier||NCT00223938, FR02023|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Hot Springs, AR||not available||no longer recruiting|
|Orange County, CA||not available||no longer recruiting|
|Simi Valley, CA||not available||no longer recruiting|
|Pembroke Pines, FL||not available||no longer recruiting|
|Winston-Salem, NC||not available||no longer recruiting|
|Canton, OH||not available||no longer recruiting|
|Columbus, OH||not available||no longer recruiting|
|Philadelphia, PA||not available||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
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
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
Male or female participants at least 18 years old.
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.
|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.|
|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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