Health Condition 1: null- non-dialysis dependent chronic kidney disease Subjects
Conditions
Interventions
Intervention1: Iron isomaltoside 1000 (Monofer®): 1.Administered as intravenous infusions (A1) upto 1000 mg at a time until total iron repletion is obtained 2.Administered as intravenous bolus injecti
Sponsors
Pharmacosmos AS
Max Neeman International
Eligibility
Inclusion criteria
Inclusion criteria: 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 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
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 and hepatitis (alanine aminotransferase (ALT) > 3 times upper normal limit) 6. Diagnosis of Hepatitis B and/or C confirmed by appropriate lab test. 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 (5 days): 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. Known intolerance to oral iron treatment. 14. Untreated B12 or folate deficiency. 15. I.V. or oral iron treatment or blood transfusion within 4 weeks prior to screening visit. 16. ESA treatment within 8 weeks prior to screening visit. 17. Serum ferritin > 500 μg/L. 18. 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. 19. History of immunodeficiency, including positive HIV test result. 20. Body weight < 30 kilograms
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intravenous iron isomaltoside 1000 (Monofer®) is non-inferior to oral iron sulphate in reducing renal related anemia in subjects with non-dialysis dependent chronic kidney disease (NDD-CKD), determined as ability to increase Hb.Timepoint: Wk 1, 2, 3, 4, and 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To assess other relevant haematology and biochemical parameters during the study. 2. Quality of Life assessment (QoL) by Linear Analog Scale Assessment (LASA). 3. To assess safety of intravenous iron isomaltoside 1000 (Monofer®) compared to oral iron sulfate. 4. Assessment of RLS symptoms and change in these symptoms during the study. Timepoint: Time Points: Wk 1, 2, 3, 4, and 8 | — |
Countries
Denmark, India, Sweden, United Kingdom
Contacts
Public ContactDr Shariq Anwar
Outcome results
None listed