Iron Isomaltoside 1000 (Monofer®) in Non-Dialysis Dependent Chronic Kidney Disease and With Renal-Related Anaemia

This study has been completed.
Sponsor:
Information provided by:
Pharmacosmos A/S
ClinicalTrials.gov Identifier:
NCT01102413
First received: March 26, 2010
Last updated: June 25, 2014
Last verified: June 2014
  Purpose

The study is designed to determine the effects of an investigational drug Monofer in subjects with non-dialysis dependent chronic kidney disease (NDD-CKD) subjects and with iron deficiency anaemia (IDA).


Condition Intervention Phase
Iron Deficiency Anemia
Chronic Kidney Disease
Drug: Monofer
Drug: Iron Sulphate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III, Randomized, Comparative, Open-label Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Administered by Infusions or Repeated Bolus Injections in Comparison With Oral Iron Sulphate in Subjects With Non-Dialysis Dependent Chronic Kidney Disease and With Renal-Related Anaemia

Resource links provided by NLM:


Further study details as provided by Pharmacosmos A/S:

Primary Outcome Measures:
  • Change in hemoglobin (Hb) concentration from baseline to week 4. [ Time Frame: Baseline, 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 1. Number of subjects who have change in Hb concentration ≥ 1.0 g/dL from baseline to week 2, 4 or 8. [ Time Frame: Baseline to week 8 ] [ Designated as safety issue: No ]

Enrollment: 351
Study Start Date: April 2010
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Monofer
Injections or infusions
Drug: Monofer
Infusion or injections
Active Comparator: Iron Sulphate
Oral intake
Drug: Iron Sulphate
Oral intake

  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. Subjects diagnosed with NDD-CKD with MDRD calculated eGFR between 15-59 mL/min.
  3. Hb < 11.0 g/dL (6.80 mmol/L)
  4. Either or both of the following iron stores indicators below target {Serum ferritin < 100 ug/l and Transferrin saturation (TfS)<20%}.
  5. Life expectancy beyond 12 months by Principal Investigator's judgement.
  6. Willingness to participate after informed consent and any authorization as required by local law ( e.g. Protected Health Information [PHI] for North America).

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 utilisation of iron (e.g. haemochromatosis and haemosiderosis).
  3. Drug hypersensitivity (i.e. previous hypersensitivity to Iron Dextran or iron mono- or disaccharide complexes or to iron sulphate or any excipients of the study drug.
  4. Subjects with history of multiple allergies.
  5. Decompensated liver cirrhosis or active hepatitis (Alanine Aminotransferase (ALT) > 3 times upper normal limit).
  6. Active acute or chronic infections ((assessed by clinical judgment), supplied with White Blood Cells (WBC) and C-Reactive Protein (CRP)).
  7. Rheumatoid arthritis with symptoms or signs of active joint inflammation.
  8. 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 (5 days): Contraceptive pills, intrauterine devices (IUD), contraceptive depot injections (prolonged-release gestagen), subdermal implantation, vaginal ring, and transdermal patches).
  9. Extensive active bleeding necessitating blood transfusion.
  10. Planned elective surgery during the study.
  11. Participation in any other clinical study within 3 months prior to screening.
  12. Known intolerance to oral iron treatment.
  13. Untreated B12 or folate deficiency.
  14. 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.
  18. Body weight < 30 kilograms.
  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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01102413

Locations
Denmark
Pharmacosmos
Holbaek, Denmark
Sponsors and Collaborators
Pharmacosmos A/S
  More Information

No publications provided

Responsible Party: Chief Midical Officer, Pharmacosmos A/S
ClinicalTrials.gov Identifier: NCT01102413     History of Changes
Other Study ID Numbers: P-Monofer-CKD-02
Study First Received: March 26, 2010
Last Updated: June 25, 2014
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Danish Medicines Agency
Denmark: Ethics Committee
Sweden: Medical Products Agency
India: Central Drugs Standard Control Organization
India: Institutional Review Board
Sweden: Regional Ethical Review Board
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee
US: FOOD AND DRUG ADMINISTRATION (FDA) and WESTERN INSTITUTIONAL REVIEW BOARD (WIRB)
Poland:Department for Clinical Trials of Medicinal Products Office for Registration of Medicinal Products, Medical Devices and Biocidal Products and Ethics Committee at the Regional Medical Chamber in Warsaw
Russia: Ministry of Health of the Russian Federation
Romania: National Agency for Drug and Medical Devices and National Ethics Committee for Drug Clinical Trial
Austria: BASG/AGES and Ethikkommission des Landes Oberösterreich
Germany: Ethikkommission der Ärztekammer Niedersachsen and BfArM
Ireland: Irish Medicines Board

Additional relevant MeSH terms:
Anemia
Renal Insufficiency, Chronic
Kidney Diseases
Anemia, Iron-Deficiency
Hematologic Diseases
Renal Insufficiency
Urologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
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 October 19, 2014