Open-label Pharmacokinetic Study of Iron Isomaltoside 1000 (Monofer®) Administered by 500 mg IV Bolus Injection or 1000 mg Intravenous to Patients With CKD

NCT01213992 | Completed Phase 1

• 1 other identifier: P-Monofer-PK-CKD-03
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Non-dialysis Dependent Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• Total serum iron pharmakokinetic parameters

  30min, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 24 hours, 48 hours and 72 hours

Study Arms (2)

Monofer® 500 mg

ACTIVE COMPARATOR

500 mg iron isomaltoside 1000

Drug: Iron isomaltoside 1000

Monofer® 1000 mg

ACTIVE COMPARATOR

1000 mg iron isomaltoside 1000

Drug: Iron isomaltoside 1000

Interventions

Iron isomaltoside 1000 DRUG

Single dose of 500 mg administered as a bolus undiluted over 2 min.

Monofer® 500 mg

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pharmacosmos A/S: lead

MeSH Terms

Interventions

iron isomaltoside 1000

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2010
• First Posted: October 4, 2010
• Study Start: March 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: November 1, 2012
• Last Updated: November 14, 2013

Record last verified: 2013-11