Clinical trial NCT00358722: An Evaluation of the Long-term Safety of Magnesium Iron Hydroxycarbonate
Official title: A Long-term, Open-label Continuation Study to Assess the Safety of Magnesium Iron Hydroxycarbonate in Haemodialysis Subjects With Hyperphosphataemia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Chronic Kidney Failure
Lead sponsor: Ineos Healthcare Limited
Sponsor class: INDUSTRY
First posted: 2006-08-01
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Fermagate is a phosphate binder that absorbs phosphate from food, reducing the amount that the body can absorb.

The purpose of this study it to look at the safety of fermagate over longer periods of time.

Detailed description: High levels of phosphate in the blood are linked with serious effects, due to calcium imbalances (high levels of parathyroid hormone (PTH), bone disease, formation of calcium deposits in the body, and blood-vessel disease).

This study is an open-label, multi-centre, single-group, 24-week study of fermagatebonate. Subjects participating in this study are those who took at least one dose of double-blind study medication in the IH 001 study and either completed study IH 001 or were withdrawn due to reasons other than an adverse event (AE) considered related to study treatment.

Eligibility criteria: Inclusion Criteria:

1. Taken at least one dose of double-blind medication during study IH 001 and either completed study IH 001 or were withdrawn due to reasons other than an AE considered related to study treatment
2. Male or female subjects on active haemodialysis, aged 18 years or over
3. Willing to abstain from taking any phosphate binder or oral magnesium-, aluminium-, or iron-containing products and preparations, other than the study medication;
4. Willing to avoid any intentional changes in diet such as fasting, dieting or overeating;
5. Willing to maintain their usual type and dose of Vitamin D supplementation.

Exclusion Criteria:

1. Participation in any other clinical trial using an investigational product or device within the previous 4 months;
2. A significant history of alcohol, drug or solvent abuse in the opinion of the investigator;
3. 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;
4. Clinically significant laboratory findings (for this subject population) in the opinion of the investigator.
5. Any malignancy with the exception of basal cell carcinoma;
6. A history of a motility disorder of the intestines, including, but not limited to, gastroparesis, ileus, pseudo-obstruction, megacolon, or mechanical obstruction;
7. A significant illness in the 4 weeks before screening;
8. Taking medication for seizures;
9. A history of haemochromatosis;
10. A history of serum ferritin concentration of ≥ 1000 ng/mL (excluding transient, treatment-induced ferritin elevation);
11. A history of dysphagia or swallowing disorders;
12. 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;
13. Current haemoglobin concentration of \< 10.00 g/dL;
14. Allergy to the IMP or its constituents.

Primary outcomes:
measure: Assessment of AEs and other safety parameters
timeFrame: 88 weeks
Secondary outcomes:
measure: Assessment of serum phosphate concentrations
timeFrame: 88 weeks
Other outcomes:
Locations:
city: Pine Bluff
country: United States
facility: 1614 West 42nd Street
state: Arkansas
city: Stuttgart
country: United States
facility: US Renal Care
state: Arkansas
city: Charlotte
country: United States
facility: Davita Dialysis Center
state: North Carolina
city: Charlotte
country: United States
facility: Southeast Renal Associates
state: North Carolina
city: Birmingham
country: United Kingdom
facility: Renal Unit, Birmingham Heartlands Hospital
city: Bradford
country: United Kingdom
facility: St Lukes Hospital, Little Horton Lane
city: Bristol
country: United Kingdom
facility: Richard Bright Renal Unit, Southmead Hospital
city: Cambridge
country: United Kingdom
facility: Addenbrookes Dialysis Centre, Addenbrookes Hospital
city: Leicester
country: United Kingdom
facility: Renal Unit, Leicester General Hospital
city: Liverpool
country: United Kingdom
facility: Dialysis Unit, Broad Green Hospital
city: Liverpool
country: United Kingdom
facility: Royal Liverpool University Hospital
city: Norwich
country: United Kingdom
facility: General Medicine and Nephrology, Norfolk and Norwich University Hospital
city: Nottingham
country: United Kingdom
facility: Nottingham Renal and Transplant Unit, Nottingham City Hospital
city: Sheffield
country: United Kingdom
facility: Sheffield Kidney Unit, Northern General Hospital
city: Swansea
country: United Kingdom
facility: Dept. of Nephrology, Morriston Hospital
Study officials:
affiliation: Nottingham City Hospital
name: Simon Roe, MB ChB
role: PRINCIPAL_INVESTIGATOR
References: