Hyperphosphataemia MedDRA version: 9.1 Level: LLT Classification code 10020711 Term: Hyperphosphataemia
Conditions
Sponsors
INEOS Healthcare Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female, aged 18 years or older. 2. Able to comply with the study procedures and medication. 3. Written informed consent given. 4. On a stable haemodialysis regimen (at least 3x per week) for at least 12 weeks prior to screening. 5. (a) Subject receiving phosphate binder medication(s) at screening, must have been on a stable regimen (dose and medication) for at least 1 month prior to screening and will remain on this regimen until entry into the washout period OR 5. (b)Subject (i) is not currently receiving any phosphate binding medication at screening (or medication likely to act as a phosphate binder) and (ii) must not have done so for at least one month and (iii) has sustained hyperphosphataemia. 6. Willing to abstain from taking any phosphate binder or oral magnesium-, oral aluminium- or oral iron-containing products and preparations other than the study medication. 7. If required to take >6000 mg/day of fermagate, the subject will be willing to have at least three meals per day. Specifically, for randomisation and inclusion into the treatment period, the following criterion must be fulfilled: 8. (a) Is not receiving phosphate binding medication at screen and has a screen serum phosphate value above 3.0 mmol/L (9.3 mg/dL) OR (b) Has a serum phosphate value of =1.94 mmol/L (=6.0 mg/dL) at Washout Visit 2 to 4 or above 3.0 mmol/L (9.3 mg/dL) at visit 1 during washout 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
Exclusion criteria: 1. Participation in any clinical trial using an investigational product or device during the 30 days preceding the Screening Visit. 2. Previous experience of fermagate treatment. 3. A significant history of alcohol, drug or solvent abuse in the opinion of the investigator. 4. Any disease or condition, physical or psychological that, in the opinion of the investigator, would compromise the safety of the subject or the likelihood of achieving reliable results or increase the likelihood of the subject being withdrawn. 5. Laboratory findings at screening which, in the opinion of the investigator, are clinically significant for this subject population. 6. A screen serum magnesium concentration of >1.25 mmol/L (>3.0 mg/dL). 7. A known history of haemochromatosis. 8. Subjects receiving either tetracycline or lithium treatment. 9. Subjects receiving nicotinamide (niacinamide) or niacin (nicotinic acid) alone (i.e. not as a constituent of a multivitamin supplementation) 10. A serum ferritin level of =1500 ng/mL (=3370 pmol/L). 11. Non-elective hospitalisation in the 4 weeks prior to screening. 12. Female subjects who are of childbearing potential and who are neither surgically sterilised nor using reliable contraceptive methods (hormonal, barrier methods or intrauterine device) or who are lactating or pregnant. 13. Current hypophosphataemia at screening (last 2 consecutive phosphate values of 560 ms at screen. 16. Known persistent (>1 month) non compliance (<70%) with prescribed medication regimens at screen. 17. Current clinically significant intestinal motility disorder. 18. Bowel obstruction with current or previous use of sevelamer HCl. 19. Known intolerance to sevelamer HCl or any excipients of fermagate or Renagel medication. 20. Subjects with inflammatory bowel disease that, in the investigator’s opinion, is poorly controlled. 21. Subjects previously withdrawn from the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to establish the non-inferiority (with possible assessment of superiority) of fermagate to sevelamer hydrochloride (HCl) in lowering serum phosphate in haemodialysis patients treated for 3 months. ;Secondary Objective: Determine the safety of fermagate after short term (3 months) and long term (6 and 12 months) treatment. Determine the efficacy of fermagate after long term treatment (6 and 12 months). Compare the effects of fermagate and sevelamer HCl on measures of mineral metabolism, albumin, pre-albumin and iron status after short term (3 months) and long term (6 and 12 months) treatment.;Primary end point(s): Efficacy: Primary efficacy endpoint: Control of serum phosphate defined as (1) a mean serum phosphate of 2.5 to 5.5 mg/dL (0.8 to 1.78 mmol/L) and (2) a difference from baseline in the serum phosphate concentrations used for the mean, of at least 0.93 mg/dL (0.3 mmol/L). The mean serum phosphate concentration will be calculated using the last two serum phosphate concentrations in the Treatment Period; if only one serum phosphate concentration is available this will be taken as the mean; if a subject has withdrawn from the Treatment Period due to abnormal serum phosphate concentrations then he/she will be deemed a non-responder (uncontrolled), regardless of their calculated mean serum phosphate concentration. The primary efficacy analysis will use the ITT and PP populations. | — |
Countries
Belgium, Bulgaria, Czech Republic, Estonia, Hungary, Italy, Lithuania, Slovakia, United Kingdom
Outcome results
None listed