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2 Doses of Ferrlecit Versus Oral Iron to Treat Iron-deficiency Anemia in Peritoneal Dialysis Patients.

NCT00223977 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2013-07-08

Study results available
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Summary

This is a phase 3 clinical investigation. Patients who meet the eligibility criteria and provide signed informed consent will be randomized to receive one of two levels of Ferrlecit or oral iron in a 1:1:1 ratio.

Conditions

Interventions

DRUG

Sodium Ferric Gluconate Complex

125 mg weekly x 8 weeks

DRUG

Sodium Ferric Gluconate Complex

250 mg weekly x 4

DRUG

Oral Iron

325 mg ferrous sulfate orally three times daily x 8 weeks

Sponsors & Collaborators

  • Watson Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Gary Hoel, RPh, PhD · Watson Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-12-31
Primary Completion
2004-11-30
Completion
2008-02-29

Countries

  • United States
  • Bulgaria
  • Canada
  • Croatia
  • India
  • Mexico
  • Poland
  • Russia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00223977 on ClinicalTrials.gov