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)

November 13, 2013 updated by: Pharmacosmos A/S

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)

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Men and women, aged more than 18 years.
  2. Weight above 50 kg.
  3. Subjects diagnosed with NDD-CKD with MDRD calculated eGFR between 15-59 mL/min.
  4. Hb < 11.0 g/dL.
  5. Either or both of the following iron stores indicators below target {Serum ferritin < 100 ug/l and Transferrin saturation (TfS) <20%}.
  6. Life expectancy beyond 12 months by Principal Investigator's judgement.
  7. Willingness to participate after informed consent.

Exclusion Criteria:

  1. Anaemia predominantly caused by factors other than renal impairment or iron deficiency (according to Principal Investigator s' judgment).
  2. Iron overload or disturbances in utilization of iron (e.g. haemochromatosis and haemosiderosis).
  3. Drug hypersensitivity (i.e. previous hypersensitivity to iron dextran or iron mono- or disaccharide complexes or any excipients of the study drug).
  4. Subjects with history of multiple allergies.
  5. Decompensated liver cirrhosis and hepatitis (alanine aminotransferase (ALT) > 3 times upper normal limit).
  6. History of Immunocompromise and/or history of Hepatitis B and/or C
  7. Active acute or chronic infections (assessed by clinical judgment), supplied with white blood cells (WBC) and C-reactive protein (CRP).
  8. Rheumatoid arthritis with symptoms or signs of active joint inflammation.
  9. 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).
  10. Extensive active bleeding necessitating blood transfusion.
  11. Planned elective surgery during the study.
  12. Participation in any other clinical study within 3 months prior to screening.
  13. Untreated B12 or folate deficiency.
  14. Other I.V. or oral iron treatment or blood transfusion within 4 weeks prior to screening visit.
  15. ESA treatment within 8 weeks prior to screening visit.
  16. Serum Ferritin > 500 µg/L
  17. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Monofer® 500 mg
500 mg iron isomaltoside 1000
Single dose of 500 mg administered as a bolus undiluted over 2 min.
Single dose of 1000 mg infused over 15 min. The infusion is diluted in 100mL 0,9% sodium chloride
ACTIVE_COMPARATOR: Monofer® 1000 mg
1000 mg iron isomaltoside 1000
Single dose of 500 mg administered as a bolus undiluted over 2 min.
Single dose of 1000 mg infused over 15 min. The infusion is diluted in 100mL 0,9% sodium chloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
30min, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 24 hours, 48 hours and 72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (ACTUAL)

October 1, 2012

Study Completion (ACTUAL)

November 1, 2012

Study Registration Dates

First Submitted

October 1, 2010

First Submitted That Met QC Criteria

October 1, 2010

First Posted (ESTIMATE)

October 4, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

November 14, 2013

Last Update Submitted That Met QC Criteria

November 13, 2013

Last Verified

November 1, 2013

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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