An open, randomised, controlled, parallel group, Phase III study to investigate the safety and efficacy of fermagate and sevelamer hydrochloride in haemodialysis patients with hyperphosphataemia.

Phase 1

• Conditions: Hyperphosphataemia; MedDRA version: 9.1Level: LLTClassification code 10020711Term: Hyperphosphataemia

• Registration Number: EUCTR2008-004730-25-CZ
• Lead Sponsor: INEOS Healthcare Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10-10
• Last Update Posted: 10 July 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 780

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

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 <0.7 mmol/L [<2.2 mg/dL]).
14.Known history of colorectal malignancy, familial polyposis coli and/or strong family history (in 2 or more first degree relatives) of these terms.
15.A QTcF interval 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified