Hyperphosphatemia MedDRA version: 9.1 Level: LLT Classification code 10020712 Term: Hyperphosphatemia
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 hemodialysis 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) Subjects (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 hyperphosphatemia. 6. Willing to abstain from taking any phosphate binder or oral magnesium-, oral aluminum- 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 randomization and inclusion into the treatment period, the following criterion must be fulfilled: 8. Has a serum phosphate value of =1.94 mmol/L (=6.0 mg/dL) within the 2 to 4 week washout period or above 3.0 mmol/L (9.3 mg/dL) at any time 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safety of the subject or the likelihood of achieving reliable results or increase the likelihood of the subject being withdrawn. 5.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 >3.0 mg/dL (>1.25 mmol/L). 7. A known history of hemochromatosis. 8. Subjects receiving either tetracycline or lithium treatment. 9. A serum ferritin level of =1000 ng/mL. 10. Non-elective hospitalization in the 4 weeks prior to screening. 11. Female subjects who are of childbearing potential and who are neither surgically sterilized nor using reliable contraceptive methods (hormonal, barrier methods or intrauterine device) or who are lactating or pregnant. 12. Current hypophosphatemia at screening (last 2 consecutive phosphate values of 560 ms at screen. 15. Known persistent (>1 month) non compliance (<70%) with prescribed medication regimens at screen. 16. Current clinically significant intestinal motility disorder. 17. Intestinal motility disorder with current or previous use of lanthanum carbonate. 18. Known intolerance to lanthanum carbonate or any excipients of fermagate or Fosrenol medication. 19. Subjects with inflammatory bowel disease that, in the investigator’s opinion, is poorly controlled.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This is a 2-stage re-randomization design where Stage 1 is a randomized, open label comparison between fermagate and lanthanum carbonate (in a non-inferiority design) and Stage 2 is a randomized double blind comparison between fermagate and placebo (in a superiority design). Stage 1: Primary Objective: The primary objective is to establish the efficacy of fermagate by demonstrating the non-inferiority (with possible assessment of superiority) of fermagate to lanthanum carbonate in lowering serum phosphate in hemodialysis patients. Objectives at Stage 2 Stage 2 will use patients who complete the 3-month maintenance period of Stage 1 and who were originally randomized to fermagate. Stage 2 :Primary Objective The primary objective is to establish efficacy of fermagate by demonstrating the superiority of fermagate over placebo in lowering serum phosphate in hemodialysis patients ;Secondary Objective: Stage 1: Secondary objectives: The secondary objectives are to: • Determine the safety of fermagate in hemodialysis patients • Compare the effects of fermagate and lanthanum carbonate on measures of mineral metabolism, albumin, pre-albumin and iron status Stage 2: Secondary objectives: The secondary objectives are to: • Determine the safety of fermagate in hemodialysis patients • Compare the effects of fermagate and placebo on measures of mineral metabolism, albumin, pre-albumin and iron status ;Primary end point(s): (Stage 1) 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 | — |
Countries
France, Germany, Spain
Outcome results
None listed