Phase III Study to Investigate the Safety and Efficacy of Fermagate and Sevelamer Hydrochloride

Inclusion Criteria: Subjects will be considered eligible for entry in the study if they meet all of thefollowing criteria.

1. Male or female, aged > 18 years.

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 ≥12 weeks prior toscreening.

5. (a) Subject receiving phosphate binder medication(s) at screening, must have been on astable regimen (dose and medication) for at least 1 month prior to screening and willremain on this regimen until entry into the washout period OR (b)Subject (i) is notcurrently receiving any phosphate binding medication at screening (or medicationlikely to act as a phosphate binder) and (ii) must not have done so for at least onemonth and (iii) has sustained hyperphosphataemia.

6. Willing to abstain from taking any phosphate binder or oral magnesium-, oralaluminium- or oral iron-containing products and preparations other than the studymedication.

7. If required to take >6000 mg/day of fermagate, the subject will be willing to have atleast three meals per day. Specifically, for randomisation and inclusion into the treatment period, the followingcriterion must be fulfilled:

8. Has a serum phosphate value of ≥1.94 mmol/L (≥6.0 mg/dL) within the 2 to 4 weekwashout period or above 3.0 mmol/L (9.3 mg/dL) at any time during washout.

Exclusion Criteria: Subjects will not be considered eligible for entry in the study if they meet one or more ofthe following criteria.

1. Participation in any clinical trial using an investigational product or device duringthe 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 theinvestigator.

4. Any disease or condition, physical or psychological that, in the opinion of theinvestigator, would compromise the safety of the subject or the likelihood ofachieving reliable results or increase the likelihood of the subject being withdrawn.

5. Laboratory findings at screening which, in the opinion of the investigator, areclinically 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. A serum ferritin level of ≥1000 ng/mL.

10. Non-elective hospitalisation in the 4 weeks prior to screening.

11. Female subjects who are of childbearing potential and who are neither surgicallysterilised nor using reliable contraceptive methods (hormonal, barrier methods orintrauterine device) or who are lactating or pregnant.

12. Current hypophosphataemia at screening (last 2 consecutive phosphate values of <0.7mmol/L [<2.2 mg/dL]).

13. Known history of colorectal malignancy, familial polyposis coli and/or strong familyhistory (in 2 or more first degree relatives) of these terms.

14. A QTcF interval of >560 ms at screen.

15. Known persistent (>1 month) non compliance (<70%) with prescribed medication regimensat screen.

16. Current clinically significant intestinal motility disorder.

17. Bowel obstruction with current or previous use of sevelamer HCl.

18. Known intolerance to sevelamer HCl or any excipients of fermagate or Renagelmedication.

19. Subjects with inflammatory bowel disease that, in the investigator's opinion, ispoorly controlled.