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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pharmacosmos A/S
ClinicalTrials.gov Identifier:
NCT01213992
First received: October 1, 2010
Last updated: November 13, 2013
Last verified: November 2013
  Purpose

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 Intervention Phase
Non-dialysis Dependent Chronic Kidney Disease
Drug: Iron isomaltoside 1000
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Pharmacosmos A/S:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: March 2012
Study Completion Date: November 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Pharmacosmos A/S
ClinicalTrials.gov Identifier: NCT01213992     History of Changes
Other Study ID Numbers: P-Monofer-PK-CKD-03, P-Monofer-PK-CKD-03
Study First Received: October 1, 2010
Last Updated: November 13, 2013
Health Authority: India: The Drugs Controller, India

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Iron
Ferric Compounds
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematinics
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014