To evaluate the efficacy and safety of ferric citrate tablet in the control of serum phosphorus levels in patients with chronic kidney disease undergoing hemodialysis.
This is a multicenter, randomized, open-label, parallel, phase III study. This study is consisting of a Screening/Washout period (14 days) and a Treatment/Observation period (12 weeks). The subjects with regular hemodialysis should stop using the phosphorus binder before the Washout period. During the Treatment period, the subjects will be randomly assigned to the ferric citrate tablets group (study group) or sevelamer carbonate tablet group (control group) in the ratio of 1:1.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
239
250mg/tablet, manufactured by Sinomune Pharmaceutical
800 mg/tablet, manufactured by Genzyme Ireland Limited
The first affiliated hospital of Baotou medical college
Baotou, China
Beijing Tongren Hospital
Beijing, China
The change in serum phosphorus levels
The change in serum phosphorus levels at the end of treatment as compared to baseline (before the first dose).
Time frame: 12 Weeks
Changes in serum phosphorus levels
Changes in serum phosphorus levels from baseline
Time frame: week 2, 4, 6, 8
Area under the curve of serum phosphorus level
Area under the curve of serum phosphorus level to visit time (AUC 0-12 weeks)
Time frame: week 0, 2, 4, 6, 8, 12
The proportion of subjects whose serum phosphorus levels reached the target
The proportion of subjects whose serum phosphorus levels reached the target range at week 4, 6, 8 and 12 of treatment (the standard was defined as blood phosphorus ≤1.78mmol /L, and ≥1.13mmol /L).
Time frame: week 4, 6, 8 and 12
The change in serum calcium (corrected) levels.
The change in serum calcium (corrected) levels at week 4, 8 and 12 of treatment as compared to baseline.
Time frame: week 4, 8 and 12
The change in the level of intact-PTH levels.
The change in the level of intact-PTH levels at week 4, 8 and 12 of treatment as compared to baseline.
Time frame: week 4, 8 and 12
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