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 on-Dialysis Dependent Chronic Kidney Disease and with Renal-Related Anaemia.
- Conditions
- on-dialysis dependent chronic kidney disease and with renal-related anaemiaMedDRA version: 16.1Level: LLTClassification code 10064848Term: Chronic kidney diseaseSystem Organ Class: 100000004857MedDRA version: 16.1Level: PTClassification code 10022972Term: Iron deficiency anaemiaSystem Organ Class: 10005329 - Blood and lymphatic system disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2009-016728-29-PL
- Lead Sponsor
- Pharmacosmos A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 350
1. Men and women, aged more than 18 years.
2. Participants 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).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
1. Anaemia predominantly caused by factors other than renal impairment or iron deficiency (according to Principal Investigators’ 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. Participants with history of multiple allergies.
5. Decompensated liver cirrhosis or 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: 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 participant to be unsuitable for the completion of the study or place the participant 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 kliograms
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To demonstrate that 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. ;Secondary Objective: 1. To assess other relevant haematology and biochemical parameters during the study.<br>2. Quality of Life assessment (QoL) by Linear Analog Scale Assessment (LASA).<br>3. To assess safety of intravenous iron isomaltoside 1000 (Monofer®) compared to oral iron sulfate.<br>4. Assessment of RLS symptoms and change in these symptoms during the study.;Primary end point(s): The primary endpoint of the study is change in Hb concentration from baseline to week 4.<br>;Timepoint(s) of evaluation of this end point: Week 4
- Secondary Outcome Measures
Name Time Method