E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with Chronic kidney disease who are in pre-dialysis or undergoing dialysis (Peritoneal Dialysis or Haemodialysis), who may be treated with erythropoeisis stimulating agents and have a need for parenteral iron due to either absolute or functional iron deficiency anaemia will be included. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10002062 |
E.1.2 | Term | Anaemia iron deficiency |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10018875 |
E.1.2 | Term | Haemodialysis |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10061105 |
E.1.2 | Term | Dialysis |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective of the present study is to obtain such safety reassurance with the use of Iron Oligosaccharide given either as repeated IV boluses or as total dose infusion (TDI) for correction/maintenance therapy of anaemia in patients with CKD with a need for parenteral iron due to either absolute or functional iron deficiency anaemia. |
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E.2.2 | Secondary objectives of the trial |
The secondary objective is to compare serum Hb, HCT, TSAT, Serum Iron and Ferritin levels after 1, 2, 4 and 8 weeks of treatment to baseline levels. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Chronic Kidney Disease (CKD) patients in pre-dialysis or undergoing dialysis not currently treated with parenteral iron may be included if they meet the following criteria:
≥ 18 years of age at screening Hb < 110g/L (6.8 mmol/L) Serum Ferritin <800 µgram/L Life expectancy beyond 12 months Willingness to participate after written informed consent
CKD patients in pre-dialysis or undergoing dialysis willing to switch their current parenteral iron maintenance therapy to MonoFer® may be included if they meet the following criteria:
≥ 18 years of age at screening Hb ≤ 130g/L Serum Ferritin <800 µgram/L Life expectancy beyond 12 months Willingness to participate after written informed consent
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E.4 | Principal exclusion criteria |
Non iron deficiency anaemia. Iron overload or disturbances in utilisation of iron (e.g haemochromatosis, haemosiderosis). Drug hypersensitivity (i.e. previous hypersensitivity to Iron Dextran or iron mono- or disaccharide complexes). Patients with a history of multiple allergies. Decompensated liver cirrhosis and hepatitis (ALAT > 3 times normal). Acute or chronic infections (clinical judgement supplied with WBC and CRP if necessary). Rheumatoid arthritis with symptoms or signs of active inflammation. Pregnancy and nursing. To avoid pregnancy, women have to be postmenopausal, surgically sterile, sexually inactive or practice reliable contraception. Active bleeding. Planned elective surgery during the study where significant blood loss is expected. Participation in any other clinical trial where the study drug has not passed five half-lives prior to screening. |
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E.5 End points |
E.5.1 | Primary end point(s) |
• Adverse events (AE) (Number and type of AE) • Serious adverse events (SAEs). • Physical examination • Vital signs (including ECG) • Clinical Laboratory Tests (Clinical Chemistry, Haematology (additional to efficacy parameters e.g. White blood cells, platelets etc))
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 14 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 6 |