The purpose of this study is to evaluate the safety and efficacy of Nephoxil capsule administration for the improvement of hyperphosphatemia in CKD patients undergoing hemodialysis under actual conditions of routine medical care.
Adults 19 years of age or older as of the ICF date
CKD patients undergoing hemodialysis to whom Nephoxil capsule shall be administered for the first time for the treatment of hyperphosphatemia as per the determination of the investigator
Patients who voluntarily decide to participate in this study and complete the ICF
Those who fall under the "Do not administer to the following patients" criteria according to Nephoxil capsule indication approval
Those who require concomitant administration of aluminum-containing medication
Others determined by the investigator to be unsuitable for participation in this study
Hyperphosphatemia in patients with CKD undergoing hemodialysis
Cohort
Prospective
the low-dose group (1.5 g/day) or the standard-dose group (4 g/day)
DrugThe initial dose of Nephoxil capsules for the subjects participating in this study shall be determined at the investigator's discretion, and subjects shall be classified into either the low-dose group (1.5 g/day) or the standard-dose group (4 g/day) according to the initial dose. It will be conducted with 13 visits over 48 weeks.
Ratio of reached target serum phosphorus level (3.5 - 5.5 mg/dL) at week 48
Ratio of reached target serum phosphorus level (3.5 - 5.5 mg/dL) at week 48
Ratio of subjects whose average serum phosphorus levels at Weeks 40, 44, and 48 reached the target serum phosphorus level (3.5 - 5.5 mg/dL)
Ratio of subjects whose average serum phosphorus levels at Weeks 40, 44, and 48 reached the target serum phosphorus level (3.5 - 5.5 mg/dL)
Mean change from baseline to week 48 in serum phosphorus level
Mean change from baseline to week 48 in serum phosphorus level
Initial dose retention period
Initial dose retention period
