The study is being conducted to evaluate the efficacy, and safety of Paricalcitol for secondary hyperparathyroidism with stage 3 and stage 4 chronic kidney disease in adults.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
84
Paricalcitol QD Treatment
Placebo QD or TIW
Percentage of participants with >30% decrease from basline at least twice in mean iPTH during the efficacy assessment phase.
Time frame: 0-24 weeks
The value of iPTH for each visit
Time frame: 0-24 weeks
The change from baseline of iPTH for each visit
Time frame: 0-24 weeks
The change percentage of iPTH for each visit;
Time frame: 0-24 weeks
The proportion of subjects whose iPTH has been reduced by more than 30% from baseline at least 4 consecutive times;
Time frame: 0-24 weeks
The change value in blood calcium from baseline;
Time frame: 0-24 weeks
The change value in blood phosphorus from baseline;
Time frame: 0-24 weeks
The change value in calcium-phosphorus product from baseline;
Time frame: 0-24 weeks
The change value of 24-hour urine calcium from baseline;
Time frame: 0-24 weeks
The change value of 24-hour urine phosphorus from baseline;
Time frame: 0-24 weeks
The change value of 24-hour creatinine clearance rate from baseline;
Time frame: 0-24 weeks
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The change value of eGFR from baseline;
Time frame: 0-24 weeks
The change value in urine calcium/creatinine ratio from baseline.
Time frame: 0-24 weeks