Iron Isomaltoside Compared With Iron Sucrosein Peritoneal Dialysis Patients

NCT03610230 | Terminated

• 1 other identifier: 1.7
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Iron Deficiency Anemia Treatment

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Secondary Outcomes (7)

• Hemoglobin level

  12 weeks

• iron profile

  12 weeks

• average weekly dose of rHuEPO

  12 weeks

• patients' subjective assessment of fatigue

  12 weeks

• health-related quality of life

  12 weeks

Study Arms (2)

Monofer

EXPERIMENTAL

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

Drug: Iron Isomaltoside; Drug: Iron sucrose

Venofer

ACTIVE COMPARATOR

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

Drug: Iron Isomaltoside; Drug: Iron sucrose

Interventions

Iron Isomaltoside DRUG

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

Also known as: Monofer

Monofer; Venofer

Iron sucrose DRUG

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

Also known as: Monofer

Monofer; Venofer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Tung Wah Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Interventions

iron isomaltoside 1000; Ferric Oxide, Saccharated

Intervention Hierarchy (Ancestors)

Ferric Compounds; Iron Compounds; Inorganic Chemicals; Glucaric Acid; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• Maggie Ming Yee Mok, MBBS FHKAM

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Honary Clinical Assitant Professor

Model Details: prospective randomized cross-over open-label trial

Study Record Dates

• First Submitted: May 31, 2018
• First Posted: August 1, 2018
• Study Start: February 1, 2019
• Primary Completion: March 30, 2021
• Study Completion: March 30, 2021
• Last Updated: October 6, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)