Iron Isomaltoside 1000 (Monofer®) in Non-Dialysis Dependent Chronic Kidney Disease and With Renal… (NCT01102413) | Clinical Trial Compass
CompletedPhase 3
Iron Isomaltoside 1000 (Monofer®) in Non-Dialysis Dependent Chronic Kidney Disease and With Renal-Related Anaemia
Denmark351 participantsStarted 2010-04
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Men and women, aged more than 18 years.
✓. Subjects diagnosed with NDD-CKD with MDRD calculated eGFR between 15-59 mL/min.
✓. Hb \< 11.0 g/dL (6.80 mmol/L)
✓. Either or both of the following iron stores indicators below target {Serum ferritin \< 100 ug/l and Transferrin saturation (TfS)\<20%}.
✓. Life expectancy beyond 12 months by Principal Investigator's judgement.
✓. 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
✕. Anaemia predominantly caused by factors other than renal impairment or iron deficiency (according to Principal Investigator's judgment).
✕. Iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and haemosiderosis).
✕. 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.
✕. Subjects with history of multiple allergies.
✕. Decompensated liver cirrhosis or active hepatitis (Alanine Aminotransferase (ALT) \> 3 times upper normal limit).
✕. Active acute or chronic infections ((assessed by clinical judgment), supplied with White Blood Cells (WBC) and C-Reactive Protein (CRP)).
What they're measuring
1
Change in Hemoglobin (Hb) Concentration From Baseline to Week 4.
✕. Rheumatoid arthritis with symptoms or signs of active joint inflammation.
✕. 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).