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Trial record 2 of 36 for:    pharmacosmos

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

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.
 
ClinicalTrials.gov Identifier: NCT01102413
Recruitment Status : Completed
First Posted : April 13, 2010
Results First Posted : December 3, 2015
Last Update Posted : December 3, 2015
Sponsor:
Information provided by (Responsible Party):
Pharmacosmos A/S

Tracking Information
First Submitted Date  ICMJE March 26, 2010
First Posted Date  ICMJE April 13, 2010
Results First Submitted Date  ICMJE September 21, 2015
Results First Posted Date  ICMJE December 3, 2015
Last Update Posted Date December 3, 2015
Study Start Date  ICMJE April 2010
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 18, 2013)
Change in Hemoglobin (Hb) Concentration From Baseline to Week 4. [ Time Frame: Baseline, 4 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 12, 2010)
Change in hemoglobin (Hb) concentration from baseline to week 8. [ Time Frame: Baseline, 8 weeks ]
Change History Complete list of historical versions of study NCT01102413 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 2, 2015)
Change in Hemoglobin Concentration From Baseline to Week 8 [ Time Frame: Baseline to week 8 ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Iron Isomaltoside 1000 (Monofer®) in Non-Dialysis Dependent Chronic Kidney Disease and With Renal-Related Anaemia
Official Title  ICMJE 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
Brief Summary 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Iron Deficiency Anemia
  • Chronic Kidney Disease
Intervention  ICMJE
  • Drug: Monofer
    Infusion or injections
  • Drug: Iron Sulphate
    Oral intake
Study Arms  ICMJE
  • Experimental: Monofer
    Injections or infusions
    Intervention: Drug: Monofer
  • Active Comparator: Iron Sulphate
    Oral intake
    Intervention: Drug: Iron Sulphate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 25, 2014)
351
Original Estimated Enrollment  ICMJE
 (submitted: April 12, 2010)
350
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01102413
Other Study ID Numbers  ICMJE P-Monofer-CKD-02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pharmacosmos A/S
Study Sponsor  ICMJE Pharmacosmos A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Pharmacosmos A/S
Verification Date November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP