Iron Isomaltoside Compared With Iron Sucrosein Peritoneal Dialysis Patients

NCT ID: NCT03610230

Last Updated: 2021-10-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-01
• Study Completion Date: 2021-03-30

Brief 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® .

Detailed Description

Anemia is commonly present in patients with end-stage renal failure (ESRF) due to insufficient endogenous erythropoietin production, absolute and functional iron deficiency. With the introduction of recombinant human erythropoietin (rHuEPO) and the accessibility of rHuEPO to dialysis patients in the Hospital Authority Drug Formulary, blood transfusion requirement for the treatment of renal related anemia has been much reduced. However, iron store must also be adequately maintained for effective erythropoiesis. The latest KDIGO guideline for anemia in chronic kidney disease recommends iron therapy either in oral or intravenous form if TSAT is ≤30% and ferritin is ≤500µg/L. Oral iron supplement is the most convenient, but it is less effective compared to intravenous forms, especially in the treatment of functional iron deficiency, and has unfavorable patient tolerability and gastro-intestinal side-effect profiles. Iron sucrose (Venofer®) is the most widely used intravenous iron preparation with good safety profile. An initial course of intravenous iron (e.g. Venofer® 200mg weekly for 5 weeks) is commonly given to iron-deplete patients before consideration of maintenance iron therapy. The absence of a vascular access and the need to return to hospital facilities for regular intravenous infusions made intravenous forms less preferred by patients on peritoneal dialysis (PD). Isomaltoside 1000 (Monofer®) consists of iron with a tighter binding to its carbohydrate moiety with less free iron to cause immunologic reactions, and thus allowing for a larger single-dose administration. This may facilitate better acceptance of intravenous iron by patients on PD. The current literature on the efficacy and safety profile of Monofer® in the treatment of renal-related anemia focus mainly on patients on hemodialysis and patients with non-dialysis dependent chronic kidney disease. There is also a lack of information on patient-reported satisfaction on the use of Monofer®. The objective of the current study is to investigate patient-reported satisfaction, efficacy and short-term safety profile of a single bolus of Monofer® compared to Venofer® in the treatment of both absolute and functional iron deficiency anemia in patients on PD. In the second part of the study, patients with recurrent iron deficiency will be crossed-over to receive treatment of the alternative arm. Similar to the first part of the study, patient-reported satisfaction and treatment efficacy will be compared following the same study protocol.

Conditions

Iron Deficiency Anemia Treatment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Monofer

Iron Isomaltoside as a single intravenous dose 1000mg over 60 minutes

Group Type: EXPERIMENTAL

Iron Isomaltoside

Intervention Type: DRUG

Iron Isomaltoside 1000 (Monofer®) consists of iron with a tighter binding to its carbohydrate moiety with less free iron

Iron sucrose

Intervention Type: DRUG

the currently most widely used intravenous iron preparation with good safety profile

Venofer

Iron Sucrose 200mg weekly intravenous infusions over 2 hours for 5 weeks

Group Type: ACTIVE_COMPARATOR

Iron Isomaltoside

Intervention Type: DRUG

Iron Isomaltoside 1000 (Monofer®) consists of iron with a tighter binding to its carbohydrate moiety with less free iron

Iron sucrose

Intervention Type: DRUG

the currently most widely used intravenous iron preparation with good safety profile

Interventions

Iron Isomaltoside

Iron Isomaltoside 1000 (Monofer®) consists of iron with a tighter binding to its carbohydrate moiety with less free iron

Intervention Type: DRUG

Iron sucrose

the currently most widely used intravenous iron preparation with good safety profile

Intervention Type: DRUG

Other Intervention Names

Monofer; Monofer

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Dr. Mok Ming Yee

Honary Clinical Assitant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maggie Ming Yee Mok, MBBS FHKAM

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Locations

Tung Wah Hospital

Hong Kong, , Hong Kong

Countries

Hong Kong

Other Identifiers

1.7

Identifier Type: -

Identifier Source: org_study_id