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Trial record 28 of 36 for:    pharmacosmos

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01213992
Recruitment Status : Completed
First Posted : October 4, 2010
Last Update Posted : November 14, 2013
Information provided by (Responsible Party):
Pharmacosmos A/S

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.

Condition or disease Intervention/treatment Phase
Non-dialysis Dependent Chronic Kidney Disease Drug: Iron isomaltoside 1000 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : March 2012
Actual Primary Completion Date : October 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Monofer® 500 mg
500 mg iron isomaltoside 1000
Drug: Iron isomaltoside 1000
Single dose of 500 mg administered as a bolus undiluted over 2 min.

Active Comparator: Monofer® 1000 mg
1000 mg iron isomaltoside 1000
Drug: Iron isomaltoside 1000
Single dose of 1000 mg infused over 15 min. The infusion is diluted in 100mL 0,9% sodium chloride

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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Responsible Party: Pharmacosmos A/S Identifier: NCT01213992     History of Changes
Other Study ID Numbers: P-Monofer-PK-CKD-03
First Posted: October 4, 2010    Key Record Dates
Last Update Posted: November 14, 2013
Last Verified: November 2013
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Ferric Compounds
Iron isomaltoside 1000
Trace Elements
Growth Substances
Physiological Effects of Drugs