Iron Deficiency Anemia TreatmentNCT03610230
Iron Isomaltoside Compared With Iron Sucrosein Peritoneal Dialysis Patients
A study testing Iron Isomaltoside and Iron sucrose in people with Iron Deficiency Anemia Treatment, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Iron Deficiency Anemia Treatment
- What is being tested?
- Iron Isomaltoside and Iron sucrose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Feb 2019to 30 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Uncontrolled malignancy
- Severe hyperparathyroidism (PTH >90 pmol/L)
- Thalassemia or hematological diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Open-label Trial Cross-over Trial of Iron Isomaltoside 1000 (Monofer®) Compared With Iron Sucrose (Venofer®) in Peritoneal Dialysis Patients
- 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.
- To compare patient symptomatology on fatigue after treatment of Monofer® compared with Venofer® .
Read the 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
- Being tested
- Iron Isomaltoside, Iron sucrose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron IsomaltosideDrug
Also called Monofer
Iron Isomaltoside 1000 (Monofer®) consists of iron with a tighter binding to its carbohydrate moiety with less free iron
Iron sucroseDrug
Also called Monofer
the currently most widely used intravenous iron preparation with good safety profile
| Study group | Role | What they receive |
|---|---|---|
| Monofer | Experimental | Iron Isomaltoside as a single intravenous dose 1000mg over 60 minutes Receives: Drug: Iron Isomaltoside; Drug: Iron sucrose |
| Venofer | Active comparator | Iron Sucrose 200mg weekly intravenous infusions over 2 hours for 5 weeks Receives: Drug: Iron Isomaltoside; Drug: Iron sucrose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-reported treatment satisfaction with Monofer® versus Venofer®
Patient-reported satisfaction is measured using three questions assessing the view of patients on the medication treatment on the 3 aspects namely effectiveness, convenience and side-effects on a 5-point Likert scale (5 is the maximum score while 1 is the minimum score) and a question on the overall satisfaction of patients with the medication treatment on a numeric rating scale (0 score indicate extremely dissatisfied up to 10, which indicates extremely satisfied). The 4 subscores will be analysed individually.
Measured: 12 weeks
Secondary outcomes (7)
Hemoglobin level
Hemoglobin level
Measured: 12 weeks
iron profile
Serum iron, ferritin, total iron binding capacity, transferrin saturation
Measured: 12 weeks
average weekly dose of rHuEPO
average weekly dose of rHuEPO
Measured: 12 weeks
patients' subjective assessment of fatigue
Visual Analogue Fatigue Scale - where patients indicate on a horizontal line measuring 100mm (where 0 mm indicates no fatigue and 100 mm point indicates very severe fagitue). The length of the patient's mark from 0mm is measured and is taken as the fatigue score
Measured: 12 weeks
health-related quality of life
Kidney Disease Quality of Life Short Form Version 1.3. It consists of 36 questions addressing quality of life. Scores of these 36 questions are calculated according to the author's manual and subsequently analysed as one final total score. The higher the score, the better the quality of life.
Measured: 12 weeks
the incidence of treatment-related adverse events of Monofer
the number of participants with treatment-related adverse events
Measured: 12 weeks
patients' subjective assessment of fatigue
SF-36 Vitality Scale. Patients were asked in the you during the past 4 weeks how the amount of energy they feel by using 4 questions on the frequency of such feelings a 6-point scale (1 indicates all of the time up to 6 which indicates none of the time). The total score of the 4 questions are averaged for analysis with the lowest score indicating more severe fatigue and the highest score indicating the least fatigue.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start1 Feb 2019
- Primary completion30 Mar 2021
- Study completion30 Mar 2021
Why it stopped: Difficult patient recruitment due to COVID-19 epidemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron Deficiency Anemia TreatmentStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- prospective randomized cross-over open-label trial
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Mok Ming Yee, The University of Hong Kong
- Investigators
- Maggie Ming Yee Mok, MBBS FHKAM, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03610230
- Sponsor's protocol ID
- 1.7
- Status last verified
- Sep 2021
- First submitted
- 31 May 2018
- Last updated
- 6 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participant data is kept confidential and is only open to investigators and co-investigators of the study
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Open-label Trial Cross-over Trial of Iron Isomaltoside 1000 (Monofer®) Compared With Iron Sucrose (Venofer®) in Peritoneal Dialysis Patients
- ClinicalTrials.gov ID
- NCT03610230
- Acronym / sponsor ID
- 1.7
- Conditions
- Iron Deficiency Anemia Treatment
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficult patient recruitment due to COVID-19 epidemic
- Enrolment
- 16 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 1 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- prospective randomized cross-over open-label trial
| Arm | Type | Receives |
|---|---|---|
| Monofer | Experimental | Drug: Iron Isomaltoside, Drug: Iron sucroseIron Isomaltoside as a single intravenous dose 1000mg over 60 minutes |
| Venofer | Active comparator | Drug: Iron Isomaltoside, Drug: Iron sucroseIron Sucrose 200mg weekly intravenous infusions over 2 hours for 5 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iron IsomaltosideAlso: MonoferIron Isomaltoside 1000 (Monofer®) consists of iron with a tighter binding to its carbohydrate moiety with less free iron | Drug | Monofer, Venofer |
| Iron sucroseAlso: Monoferthe currently most widely used intravenous iron preparation with good safety profile | Drug | Monofer, Venofer |
Primary outcome
Patient-reported treatment satisfaction with Monofer® versus Venofer®
Time frame: 12 weeks
Patient-reported satisfaction is measured using three questions assessing the view of patients on the medication treatment on the 3 aspects namely effectiveness, convenience and side-effects on a 5-point Likert scale (5 is the maximum score while 1 is the minimum score) and a question on the overall satisfaction of patients with the medication treatment on a numeric rating scale (0 score indicate extremely dissatisfied up to 10, which indicates extremely satisfied). The 4 subscores will be analysed individually.
7 secondary outcomes
Hemoglobin level
Time frame: 12 weeks
iron profile
Time frame: 12 weeks
average weekly dose of rHuEPO
Time frame: 12 weeks
patients' subjective assessment of fatigue
Time frame: 12 weeks
health-related quality of life
Time frame: 12 weeks
the incidence of treatment-related adverse events of Monofer
Time frame: 12 weeks
patients' subjective assessment of fatigue
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: Difficult patient recruitment due to COVID-19 epidemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2021.
- Individual participant dataSharing planned: No. Participant data is kept confidential and is only open to investigators and co-investigators of the study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maggie Ming Yee Mok, MBBS FHKAM principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iron Isomaltoside and Iron sucrose in people with Iron Deficiency Anemia Treatment, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Difficult patient recruitment due to COVID-19 epidemic). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-reported treatment satisfaction with Monofer® versus Venofer® (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2021; AzTrials last refreshed its copy on 7 Nov 2026.