Iron Isomaltoside Compared With Iron Sucrosein Peritoneal Dialysis Patients

• Status: Terminated
• Trial end date: 2021-03-30
• Target enrollment: 0
• Participant gender: All

Summary

1. To compare patient-reported satisfaction, efficacy and short-term safety profile of Monofer® in a single bolus dose with Venofer® in split doses in the treatment of absolute or functional iron deficiency anemia in patients on PD.

2. To compare patient symptomatology on fatigue after treatment of Monofer® compared with Venofer® .

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Hong Kong
• Treatments: Ferric Compounds; Ferric Oxide, Saccharated; Iron; Iron isomaltoside 1000

Criteria

Inclusion Criteria:

• Hemoglobin (Hb) level between 8-12g/dL for the previous 4 weeks prior to screening

• TSAT ≤30% and ferritin ≤500µg/L

• Receiving a stable dose of rHuEPO therapy for the previous 4 weeks prior to screening

• Not on intravenous iron therapy for the previous 4 weeks prior to screening

• Minimum weekly total Kt/V of 1.7

• Able to give informed consent

Exclusion Criteria:

• No evidence of active blood loss or hemolysis

• Untreated Vitamin B12 or folate deficiency

• History of multiple allergies

• Iron overload

• Active acute or chronic infections

• Blood transfusion within the previous 12 weeks

• Uncontrolled malignancy

• Severe hyperparathyroidism (PTH >90 pmol/L)

• Thalassemia or hematological diseases