Comparison Between Effects of Two Iron Preparations on Protein in the Urine

Watson Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Anemia, Iron-Deficiency; Kidney Failure, Chronic

Treatments: Drug: iron sucrose injection, USP; Drug: sodium ferric gluconate complex in sucrose injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT00534144

FER0701

Details and patient eligibility

About

This study will compare the effects of sodium ferric gluconate complex and iron sucrose on urine concentrations of various chemicals including protein

Enrollment: 74 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, not receiving dialysis
• Age ≥ 18 or greater and able to give informed consent

Exclusion criteria

• Known sensitivity to Sodium Ferric Gluconate Complex in Sucrose Injection, Iron sucrose USP, or any of their components
• Clinically unstable
• Indication of iron sufficiency
• Bladder obstruction conditions that would not allow for good urine output

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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74 participants in 2 patient groups

Iron Sucrose

Active Comparator group

Treatment:

Drug: iron sucrose injection, USP

Ferric Gluconate

Active Comparator group

Treatment:

Drug: sodium ferric gluconate complex in sucrose injection