To evaluate the efficacy and safety of ferric citrate capsules for the treatment of hyperphosphatemia in patients with chronic kidney disease undergoing hemodialysis
This is a multicenter, randomized, open-label, active-controlled, parallel, phase III study which aims to assess the efficacy and safety of ferric citrate capsules for the treatment of hyperphosphatemia in patients with chronic kidney disease undergoing hemodialysis. This study is consisting of a Screening/Washout period (14 days) and a Treatment/Observation period (12 weeks). During the Treatment period, the subjects will be randomly assigned to the ferric citrate capsule 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
240
Take the capsules with meals or immediately after meals.
Take the tablets with meals.
Baotou Central Hospital
Baotou, China
The change in serum phosphorus levels
The change in serum phosphorus levels at the end of treatment (Visit 10 or ET) as compared to baseline (before the first dose).
Time frame: 12 Weeks
Serum phosphorus levels
Serum phosphorus levels at the end of treatment;
Time frame: 12 Weeks
The proportion of subjects whose serum phosphorus levels reached the target range.
The proportion of subjects whose serum phosphorus levels reached the target range (3.5 to 5.5 mg/dL, 1.13 to 1.78 mmol/L) at the end of the treatment;
Time frame: 12 Weeks
The response rate of serum phosphorus
The response rate of serum phosphorus at the end of treatment (defined as reduction of the serum phosphorus level exceeds 25% as compared to baseline);
Time frame: 12 Weeks
The change in serum calcium (corrected) levels
The change in serum calcium (corrected) levels at the end of treatment as compared to baseline;
Time frame: 12 Weeks
The change in the [Ca] × [P] product relative
The change in the \[Ca\] × \[P\] product relative at the end of treatment as compared to baseline;
Time frame: 12 Weeks
The change in the level of intact-PTH levels
The change in the level of intact-PTH levels at the end of treatment as compared to baseline.
Time frame: 12 Weeks
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