A non-comparative open-label study of Iron Oligosaccharide in Chronic Kidney Disease patients with a need for parenteral iro

Conditions: 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: 9.1Level: LLTClassification code 10002062Term: Anaemia iron deficiency
MedDRA version: 9.1Level: LLTClassification code 10018875Term: Haemodialysis
MedDRA version: 9.1Level: LLTClassification code 10061105Term: Dialysis

Registration Number: EUCTR2007-000765-37-DK

Lead Sponsor: Pharmacosmos A/S

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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) <br>•Serious adverse events (SAEs).<br>•Physical examination<br>•Vital signs (including ECG)<br>•Clinical Laboratory Tests (Clinical Chemistry, Haematology (additional to efficacy parameters e.g. White blood cells, platelets etc))<br>;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 Outcome Measures