Endstage Renal Disease Clinical Trial
Official title:
The Effect of Phosphate Lowering Using Sucroferric Oxyhydroxide (PA21) on Calcification Propensity of Serum
This is a single-center, prospective, open-label, controlled, randomized, cross-over study in 34 prevalent end-stage renal disease patients on chronic hemodialysis treatment with hyperphosphatemia.
Patients will be randomized in a 1:1 ratio to either receive low-dose (250mg/d) PA-21
followed by high-dose (2000mg/d) PA-21 (sequence A-B) or to receive high-dose PA21 followed
by low-dose PA21 (sequence B-A) with washout-phases in between. An open label design with a
sub-therapeutic dose of PA21 as control treatment was chosen because creating a convincing
placebo for PA21 is not feasible.
The study will start with two study visits on the 2nd and 3rd dialysis session of the week ,
where dialysis patients are still treated with standard of care to establish baseline values
(duration: 0.5 weeks). Next will be an initial run-in wash-out phase, where all phosphate
binders taken by the patient as standard of care treatment will be discontinued and no
phosphate binders will be introduced. Consequently, there will be a PA21 treatment (high
dose/low dose) phase, followed by a wash-out phase, followed by another PA21 treatment (high
dose/low dose) phase, followed by a final wash-out phase. Each study phase, including
wash-out phases as well as low-dose and high-dose treatment phases will be 14 days of
duration. Patients will be followed up to 10.5 weeks after randomization until the last study
visit of the final wash-out phase.
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