Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:42 PM
Ignite Modification Date:
2025-12-24 @ 4:42 PM
NCT ID:
NCT00536666
Eligibility Criteria:
Inclusion Criteria:
Chronic kidney disease 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 \< 110 g/L (6.8 mmol/L)
* Serum ferritin \< 800 µgram/L
* Life expectancy beyond 12 months
* Willingness to participate after written informed consent
Chronic kidney disease patients in pre-dialysis or undergoing dialysis willing to switch their current parenteral iron maintenance therapy to iron oligosaccharide may be included if they meet the following criteria:
* ≥ 18 years of age at screening
* Hb ≤ 130 g/L
* Serum ferritin \> 200 µgram/L but \< 800 µgram/L
* Life expectancy beyond 12 months
* Willingness to participate after written informed consent
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 (alanine aminotransferase \> 3 times normal).
* Acute or chronic infections
* 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 within three months prior to screening
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00536666
Study Brief:
Protocol Section:
NCT00536666