An Evaluation of the Long-term Safety of Magnesium Iron Hydroxycarbonate (ALCON)
Chronic Kidney Failure
About this trial
This is an interventional treatment trial for Chronic Kidney Failure
Eligibility Criteria
Inclusion Criteria: Taken at least one dose of double-blind medication during study IH 001 and either completed study IH 001 or were withdrawn due to reasons other than an AE considered related to study treatment Male or female subjects on active haemodialysis, aged 18 years or over Willing to abstain from taking any phosphate binder or oral magnesium-, aluminium-, or iron-containing products and preparations, other than the study medication; Willing to avoid any intentional changes in diet such as fasting, dieting or overeating; Willing to maintain their usual type and dose of Vitamin D supplementation. Exclusion Criteria: Participation in any other clinical trial using an investigational product or device within the previous 4 months; A significant history of alcohol, drug or solvent abuse in the opinion of the investigator; Any disease or condition, physical or psychological, which in the opinion of the investigator would compromise the safety of the subject or increase the likelihood of the subject being withdrawn; Clinically significant laboratory findings (for this subject population) in the opinion of the investigator. Any malignancy with the exception of basal cell carcinoma; A history of a motility disorder of the intestines, including, but not limited to, gastroparesis, ileus, pseudo-obstruction, megacolon, or mechanical obstruction; A significant illness in the 4 weeks before screening; Taking medication for seizures; A history of haemochromatosis; A history of serum ferritin concentration of ≥ 1000 ng/mL (excluding transient, treatment-induced ferritin elevation); A history of dysphagia or swallowing disorders; Female subjects who are lactating or pregnant. Women of childbearing potential (pre-menopausal and not surgically sterilised) unless they abstain from sexual intercourse or are using a reliable contraceptive method, that is, barrier methods, hormones or intrauterine device; Current haemoglobin concentration of < 10.00 g/dL; Allergy to the IMP or its constituents.
Sites / Locations
- 1614 West 42nd Street
- US Renal Care
- Davita Dialysis Center
- Southeast Renal Associates
- Renal Unit, Birmingham Heartlands Hospital
- St Lukes Hospital, Little Horton Lane
- Richard Bright Renal Unit, Southmead Hospital
- Addenbrookes Dialysis Centre, Addenbrookes Hospital
- Renal Unit, Leicester General Hospital
- Dialysis Unit, Broad Green Hospital
- Royal Liverpool University Hospital
- General Medicine and Nephrology, Norfolk and Norwich University Hospital
- Nottingham Renal and Transplant Unit, Nottingham City Hospital
- Sheffield Kidney Unit, Northern General Hospital
- Dept. of Nephrology, Morriston Hospital
Arms of the Study
Arm 1
Experimental
Fermagate