Effect of Two Iron Preparations on Protein in the Urine

Watson Pharmaceuticals

Status and phase: Completed; Phase 4

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

Treatments: Drug: Sodium Ferric Gluconate and Iron sucrose

Study type: Interventional

Funder types: Industry

Identifiers

NCT00354692

FER0601

Details and patient eligibility

About

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

Enrollment: 12 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
• Age ≥ 18 or greater and able to give informed consent

Exclusion criteria

• Receiving dialysis
• Known sensitivity to Sodium Ferric Gluconate Complex in Sucrose Injection, Iron sucrose USP, or any of their components
• Clinically unstable
• Indication of iron sufficiency

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Experimental

Experimental group

Treatment:

Drug: Sodium Ferric Gluconate and Iron sucrose