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Effect of Ferrlecit® Versus Oral Iron on Iron Deficient Chronic Kidney Disease (CKD) Patients

W

Watson Pharmaceuticals

Status and phase

Completed
Phase 4

Conditions

Anemia, Iron-Deficiency
Kidney Failure, Chronic

Treatments

Drug: Ferrous sulfate tablets
Drug: Sodium Ferric Gluconate Complex in Sucrose Injection

Study type

Interventional

Funder types

Industry

Identifiers

NCT00224055
FER0202

Details and patient eligibility

About

This study compares the effect of Ferrlecit® (a form of intravenous iron) to ferrous sulfate (a form of oral iron) in treating anemia and iron deficiency in chronic kidney disease patients who are not receiving erythropoietic agents (hormones that stimulate the bone marrow to make more red blood cells).

Enrollment

89 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Moderate to severe anemia
  • Iron deficiency
  • Moderate to severe chronic kidney disease

Exclusion criteria

  • Receiving dialysis
  • Known sensitivity to Ferrlecit® or any of its components
  • Receiving therapy with erythropoietic agent
  • Clinically unstable

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

89 participants in 2 patient groups

IV iron
Experimental group
Description:
Sodium ferric gluconate
Treatment:
Drug: Sodium Ferric Gluconate Complex in Sucrose Injection
oral iron
Active Comparator group
Description:
ferrous sulfate
Treatment:
Drug: Ferrous sulfate tablets

Trial contacts and locations

24

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Data sourced from clinicaltrials.gov

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