Patients with Chronic kidney disease who are in pre-dialysis or undergoing dialysis (either 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. MedDRA version: 9.1 Level: LLT Classification code 10002062 Term: Anaemia iron deficiency MedDRA version: 9.1 Level: LLT Classification code 10018875 Term: Haemodialysis MedDRA version: 9.1 Lev
Conditions
Sponsors
Pharmacosmos A/S
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: 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.;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)) | — |
Countries
Denmark, Sweden, United Kingdom
Outcome results
None listed