Periodic Versus Continuous IV Iron Supplementation in HD Patients

Papageorgiou General Hospital

Status and phase: Completed; Phase 4

Conditions: Anemia of Chronic Kidney Disease

Treatments: Drug: Iron Sucrose Supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT02787824

637/13.7

Details and patient eligibility

About

The purpose of this study was to compare the efficacy of two regimens of intravenous iron sucrose [continuous (in every hemodialysis session) versus intermittent (every 1-4 weeks)] on the response of rHuEPO in the maintenance phase of its administration in hemodialysis patients.

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Constant rHu-EPO and iron dose for at least 2 months before starting the study
• Hemoglobin ≥ 8,5g/dl and <12,5 g/dl
• Ferritin < 1000 mg/dl
• TSAT < 50%
• CRP < 5 mg/dl

Exclusion criteria

• Malignant tumor disease
• Oral iron supplementation
• Active bleeding issues
• Surgical intervention within the last 8 weeks before study inclusion

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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27 participants in 2 patient groups

continuous iv administration of iron sucrose

Experimental group

Description:

Prior to the study, all our patients were receiving intravenous iron sucrose in an intermittent mode (every 1-4 weeks).Patients on this arm will receive the same previous dose of iron glucose but in a continuous mode (smaller doses of iron sucrose in every session).

Treatment:

Drug: Iron Sucrose Supplement

intermittent iv administration of iron sucrose

Active Comparator group

Description:

Patients on this arm will continue to receive the same previous intermittent mode of iron sucrose.

Treatment:

Drug: Iron Sucrose Supplement