Overview

This trial is active, not recruiting.

Condition anemia
Treatments oral iron, sodium ferric gluconate
Phase phase 4
Sponsor Watson Pharmaceuticals
Start date May 2004
End date September 2009
Trial size 291 participants
Trial identifier NCT00223938, FR02023

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Oral Iron
oral iron Ferrous sulfate
Oral Iron
(Experimental)
sodium ferric gluconate
sodium ferric gluconate Ferrlecit
weekly intravenous injection Dose 1
(Experimental)
sodium ferric gluconate
sodium ferric gluconate Ferrlecit
weekly intravenous injection Dose 2

Primary Outcomes

Measure
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 Outcomes

Measure
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

Eligibility Criteria

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.

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2008.
Information provided to ClinicalTrials.gov by Watson Pharmaceuticals.