Clinical trial NCT00223938: Study of the Efficacy and Safety of Ferrlecit in the Maintenance Dosing in Hemodialysis Patients.
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Anemia
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2005-09-22
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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 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.

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.
timeFrame: 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.
timeFrame: 22 weeks
Other outcomes:
Locations:
city: Hot Springs
country: United States
state: Arkansas
city: Orange County
country: United States
state: California
city: Simi Valley
country: United States
state: California
city: Pembroke Pines
country: United States
state: Florida
city: Winston-Salem
country: United States
state: North Carolina
city: Canton
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Philadelphia
country: United States
state: Pennsylvania
Study officials:
affiliation: Watson Pharmaceuticals
name: Gary Hoel, RPh, PhD
role: STUDY_DIRECTOR
References: