Clinical trial NCT03610230: Iron Isomaltoside Compared With Iron Sucrosein Peritoneal Dialysis Patients
Official title: A Randomized Open-label Trial Cross-over Trial of Iron Isomaltoside 1000 (Monofer®) Compared With Iron Sucrose (Venofer®) in Peritoneal Dialysis Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Iron Deficiency Anemia Treatment
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2018-08-01
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: prospective randomized cross-over open-label trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Patient-reported treatment satisfaction with Monofer® versus Venofer®
timeFrame: 12 weeks
Secondary outcomes:
measure: Hemoglobin level
timeFrame: 12 weeks
measure: iron profile
timeFrame: 12 weeks
measure: average weekly dose of rHuEPO
timeFrame: 12 weeks
measure: patients' subjective assessment of fatigue
timeFrame: 12 weeks
measure: health-related quality of life
timeFrame: 12 weeks
measure: the incidence of treatment-related adverse events of Monofer
timeFrame: 12 weeks
measure: patients' subjective assessment of fatigue
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Tung Wah Hospital
Study officials:
affiliation: The University of Hong Kong
name: Maggie Ming Yee Mok, MBBS FHKAM
role: PRINCIPAL_INVESTIGATOR
References: