Iron-magnesium hydroxycarbonate (fermagate): a novel non-calcium-containing phosphate binder for the treatment of hyperphosphatemia in chronic hemodialysis patients.
OBJECTIVE
This phase II study tested the safety and efficacy of fermagate, a calcium-free iron and magnesium hydroxycarbonate binder, for treating hyperphosphatemia in hemodialysis patients.


METHODS
A randomized, double-blind, three-arm, parallel-group study compared two doses of fermagate (1 g three times daily or 2 g three times daily with placebo). Sixty-three patients who had been on a stable hemodialysis regimen for > or =3 mo were randomized to the treatment phase. Study medication was administered three times daily just before meals for 21 d. The primary endpoint was reduction in serum phosphate over this period.


RESULTS
In the intention-to-treat analysis, mean baseline serum phosphate was 2.16 mmol/L. The fermagate 1- and 2-g three-times-daily treatment arms were associated with statistical reductions in mean serum phosphate to 1.71 and 1.47 mmol/L, respectively. Adverse event (AE) incidence in the 1-g fermagate arm was statistically comparable to the placebo group. The 2-g arm was associated with a statistically higher number of patients reporting AEs than the 1-g arm, particularly gastrointestinal AEs, as well as a higher number of discontinuations, complicating interpretation of this dose's efficacy. Both doses were associated with elevations of prehemodialysis serum magnesium levels.


CONCLUSIONS
The efficacy and tolerability of fermagate were dose dependent. Fermagate showed promising efficacy in the treatment of hyperphosphatemia in chronic hemodialysis patients as compared with placebo in this initial phase II study. The optimal balance between efficacy and tolerability needs to be determined from future dose-titration studies, or fixed-dose comparisons of more doses.
McIntyre
Christopher W
CW
Derby Hospitals NHS Foundation Trust, Derby, and INEOS Healthcare, Warrington, United Kingdom. chris.mcintyre@nottingham.ac.uk
Pai
Pearl
P
Warwick
Graham
G
Wilkie
Martin
M
Toft
Alex J
AJ
Hutchison
Alastair J
AJ
D002118:Calcium / Q000097:blood; D002254:Carbonates / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002784:Cholesterol / Q000097:blood; D002908:Chronic Disease; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004739:England; D006801:Humans; D054559:Hyperphosphatemia / Q000097:blood / Q000188:drug therapy* / Q000209:etiology; D007501:Iron / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D007674:Kidney Diseases / Q000150:complications / Q000628:therapy*; D008274:Magnesium / Q000008:administration & dosage / Q000009:adverse effects / Q000097:blood / Q000627:therapeutic use*; D010710:Phosphates / Q000097:blood; D006435:Renal Dialysis / Q000009:adverse effects; D016896:Treatment Outcome
D002254:Carbonates; D010710:Phosphates; D002784:Cholesterol; D007501:Iron; D008274:Magnesium; C541219:iron-magnesium hydroxycarbonate; D002118:Calcium