Evaluate Safety and Efficacy of Paricalcitol in Reducing Serum Intact Parathyroid Hormone in Chronic Kidney Disease
Evaluate the safety and efficacy of paricalcitol injection with two different dosing regimens (currently approved dosing regimen used in the US package insert versus dosing based on a formula of iPTH/80 that was approved and used in the EU package insert) in Chronic Kidney Disease (CKD) Stage 5 subjects with secondary hyperparathyroidism receiving hemodialysis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
216
Initiation dosing based on 2 approved package inserts , followed by a dose adjusted by limited chemistry test value. See Arm Description for additional details.
Site Reference ID/Investigator# 23483
Beijing, China
Site Reference ID/Investigator# 23485
Beijing, China
Site Reference ID/Investigator# 23482
Beijing, China
The Achievement of Two Consecutive Greater Than or Equal to 30% Decreases From Baseline Intact Parathyroid Hormone Levels
The number of participants who achieved (Yes) or did not achieve (No) two consecutive decreases of greater than or equal to 30% from baseline in intact parathyroid hormone (iPTH) values
Time frame: Baseline to 12 Weeks
The Proportion of Subjects Achieving a Final Intact Parathyroid Hormone Value Between 150 and 300 pg/mL
The number of subjects with (Yes) or without (No) final intact parathyroid hormone (iPTH) values between 150 and 300 pg/mL
Time frame: Baseline to 12 Weeks
The Change From Baseline to the Final Observation in Intact Parathyroid Hormone Value
Time frame: Baseline to 12 Weeks
The Change From Baseline to the Final Observation in Calcium
Time frame: Baseline to 12 Weeks
The Change From Baseline to the Final Observation in Calcium-phosphorus Product
Time frame: Baseline to 12 Weeks
The Change From Baseline to the Final Observation in the Vital Sign of Systolic Blood Pressure
Time frame: Baseline to 12 Weeks
The Change From Baseline to the Final Observation in the Vital Sign of Diastolic Blood Pressure
Time frame: Baseline to 12 Weeks
The Change From Baseline to the Final Observation in the Vital Sign of Heart Rate
Time frame: Baseline to 12 Weeks
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Site Reference ID/Investigator# 23484
Dalian, China
Site Reference ID/Investigator# 23486
Guangzhou, China
Site Reference ID/Investigator# 23488
Nanjing, China
Site Reference ID/Investigator# 37722
Qingdao, China
Site Reference ID/Investigator# 23490
Shanghai, China
Site Reference ID/Investigator# 25502
Shanghai, China
Site Reference ID/Investigator# 23489
Shanghai, China
...and 2 more locations
The Proportion of Subjects With 2 Consecutive Calcium Measurements Greater Than 11.0 mg/dL (2.75 mmol/L)
The number of subjects with (Yes) or without (No) two consecutive calcium measurements greater than 11.0 mg/dL (2.75 mmol/L)
Time frame: Baseline to 12 weeks