Open-label Pharmacokinetic Study of Iron Isomaltoside 1000 (Monofer®) Administered by 500 mg IV Bolus Injection or 1000 mg Intravenous to Patients With CKD (PK-CKD-03)
Primary Purpose
Non-dialysis Dependent Chronic Kidney Disease
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Iron isomaltoside 1000
Iron isomaltoside 1000
Sponsored by
About this trial
This is an interventional treatment trial for Non-dialysis Dependent Chronic Kidney Disease
Eligibility Criteria
Inclusion Criteria:
- Men and women, aged more than 18 years.
- Weight above 50 kg.
- Subjects diagnosed with NDD-CKD with MDRD calculated eGFR between 15-59 mL/min.
- Hb < 11.0 g/dL.
- Either or both of the following iron stores indicators below target {Serum ferritin < 100 ug/l and Transferrin saturation (TfS) <20%}.
- Life expectancy beyond 12 months by Principal Investigator's judgement.
- Willingness to participate after informed consent.
Exclusion Criteria:
- Anaemia predominantly caused by factors other than renal impairment or iron deficiency (according to Principal Investigator s' judgment).
- Iron overload or disturbances in utilization of iron (e.g. haemochromatosis and haemosiderosis).
- Drug hypersensitivity (i.e. previous hypersensitivity to iron dextran or iron mono- or disaccharide complexes or any excipients of the study drug).
- Subjects with history of multiple allergies.
- Decompensated liver cirrhosis and hepatitis (alanine aminotransferase (ALT) > 3 times upper normal limit).
- History of Immunocompromise and/or history of Hepatitis B and/or C
- Active acute or chronic infections (assessed by clinical judgment), supplied with white blood cells (WBC) and C-reactive protein (CRP).
- Rheumatoid arthritis with symptoms or signs of active joint inflammation.
- Pregnancy and nursing (To avoid pregnancy, women have to be postmenopausal (at least 12 months must have elapsed since last menstruation), surgically sterile, or women of child bearing potential must use one of the following contraceptives during the whole study period and after the study has ended for at least 5 times plasma biological half-life of the investigational medicinal product: Contraceptive pills, intrauterine devices (IUD), contraceptive depot injections (prolonged-release gestagen), subdermal implantation, vaginal ring, and transdermal patches).
- Extensive active bleeding necessitating blood transfusion.
- Planned elective surgery during the study.
- Participation in any other clinical study within 3 months prior to screening.
- Untreated B12 or folate deficiency.
- Other I.V. or oral iron treatment or blood transfusion within 4 weeks prior to screening visit.
- ESA treatment within 8 weeks prior to screening visit.
- Serum Ferritin > 500 µg/L
- Any other medical condition that, in the opinion of Principal Investigator, may cause the subject to be unsuitable for the completion of the study or place the subject at potential risk from being in the study or interfere with study drug evaluation. Example, Uncontrolled Hypertension, Unstable Ischemic Heart Disease or Uncontrolled Diabetes Mellitus.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Monofer® 500 mg
Monofer® 1000 mg
Arm Description
500 mg iron isomaltoside 1000
1000 mg iron isomaltoside 1000
Outcomes
Primary Outcome Measures
Total serum iron pharmakokinetic parameters
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01213992
Brief Title
Open-label Pharmacokinetic Study of Iron Isomaltoside 1000 (Monofer®) Administered by 500 mg IV Bolus Injection or 1000 mg Intravenous to Patients With CKD
Acronym
PK-CKD-03
Official Title
Open-label Pharmacokinetic Study of Iron Isomaltoside 1000 (Monofer®) Administered by 500 mg IV Bolus Injection or 1000 mg Intravenous Infusion to Patients With Non-Dialysis Dependent Chronic Kidney Disease (PK-CKD-03)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pharmacosmos A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to assess the pharmakokinetic properties of higher doses (500 mg and 1000 mg) of Monofer® in patients suffering from Non-dialysis Dependent Chronic Kidney Disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-dialysis Dependent Chronic Kidney Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Monofer® 500 mg
Arm Type
Active Comparator
Arm Description
500 mg iron isomaltoside 1000
Arm Title
Monofer® 1000 mg
Arm Type
Active Comparator
Arm Description
1000 mg iron isomaltoside 1000
Intervention Type
Drug
Intervention Name(s)
Iron isomaltoside 1000
Intervention Description
Single dose of 500 mg administered as a bolus undiluted over 2 min.
Intervention Type
Drug
Intervention Name(s)
Iron isomaltoside 1000
Intervention Description
Single dose of 1000 mg infused over 15 min. The infusion is diluted in 100mL 0,9% sodium chloride
Primary Outcome Measure Information:
Title
Total serum iron pharmakokinetic parameters
Time Frame
30min, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 24 hours, 48 hours and 72 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men and women, aged more than 18 years.
Weight above 50 kg.
Subjects diagnosed with NDD-CKD with MDRD calculated eGFR between 15-59 mL/min.
Hb < 11.0 g/dL.
Either or both of the following iron stores indicators below target {Serum ferritin < 100 ug/l and Transferrin saturation (TfS) <20%}.
Life expectancy beyond 12 months by Principal Investigator's judgement.
Willingness to participate after informed consent.
Exclusion Criteria:
Anaemia predominantly caused by factors other than renal impairment or iron deficiency (according to Principal Investigator s' judgment).
Iron overload or disturbances in utilization of iron (e.g. haemochromatosis and haemosiderosis).
Drug hypersensitivity (i.e. previous hypersensitivity to iron dextran or iron mono- or disaccharide complexes or any excipients of the study drug).
Subjects with history of multiple allergies.
Decompensated liver cirrhosis and hepatitis (alanine aminotransferase (ALT) > 3 times upper normal limit).
History of Immunocompromise and/or history of Hepatitis B and/or C
Active acute or chronic infections (assessed by clinical judgment), supplied with white blood cells (WBC) and C-reactive protein (CRP).
Rheumatoid arthritis with symptoms or signs of active joint inflammation.
Pregnancy and nursing (To avoid pregnancy, women have to be postmenopausal (at least 12 months must have elapsed since last menstruation), surgically sterile, or women of child bearing potential must use one of the following contraceptives during the whole study period and after the study has ended for at least 5 times plasma biological half-life of the investigational medicinal product: Contraceptive pills, intrauterine devices (IUD), contraceptive depot injections (prolonged-release gestagen), subdermal implantation, vaginal ring, and transdermal patches).
Extensive active bleeding necessitating blood transfusion.
Planned elective surgery during the study.
Participation in any other clinical study within 3 months prior to screening.
Untreated B12 or folate deficiency.
Other I.V. or oral iron treatment or blood transfusion within 4 weeks prior to screening visit.
ESA treatment within 8 weeks prior to screening visit.
Serum Ferritin > 500 µg/L
Any other medical condition that, in the opinion of Principal Investigator, may cause the subject to be unsuitable for the completion of the study or place the subject at potential risk from being in the study or interfere with study drug evaluation. Example, Uncontrolled Hypertension, Unstable Ischemic Heart Disease or Uncontrolled Diabetes Mellitus.
12. IPD Sharing Statement
Learn more about this trial
Open-label Pharmacokinetic Study of Iron Isomaltoside 1000 (Monofer®) Administered by 500 mg IV Bolus Injection or 1000 mg Intravenous to Patients With CKD
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