This study is a exploratory comparison of the efficacy and safety of paricalcitol injection with maxacalcitol injection in chronic kidney disease participants receiving hemodialysis with secondary hyperparathyroidism.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
47
Intravenous administration 3 times a week immediately before completion of dialysis
Intravenous administration 3 times a week immediately before completion of dialysis
Site Ref # / Investigator 53794
Anjo, Japan
Site Ref # / Investigator 53787
Chiba, Japan
Site Ref # / Investigator 53786
Kumagaya, Japan
The Percentage of Participants With a >=50% Reduction in Intact Parathyroid Hormone (iPTH) From Baseline Compared to the Average iPTH Obtained in the Last 3 Weeks.
Time frame: Baseline and the last 3 weeks (Weeks 11, 12, and 13)
The Percentage of Participants With iPTH Within Target Range of 60-180 pg/mL, Based on the Average iPTH Obtained in the Last 3 Weeks
Time frame: During the last 3 weeks (Weeks 11, 12, and 13)
Mean iPTH at Each Visit
Time frame: Screening (up to 2 weeks before Baseline) to Week 13
Mean Change in iPTH From Baseline to the Average iPTH Obtained in the Last 3 Weeks
Time frame: Baseline and the last 3 weeks (Weeks 11, 12, and 13)
Percentage of Participants With a >= 50% Reduction in iPTH From Baseline to the Average iPTH Obtained in the Last 3 Weeks and Without Hypercalcemia During Treatment
Hypercalcemia was defined as at least 1 corrected calcium \> 11.5 mg/dL or at least 2 consecutive corrected calcium \>= 11.0 mg/dL.
Time frame: Baseline and the last 3 weeks (Weeks 11, 12, and 13) for iPTH and anytime during the 12-week treatment period for hypercalcemia
Percentage of Participants With iPTH Within the Target Range of 60-180 pg/mL Based on the Average iPTH Obtained in the Last 3 Weeks of the Study and Without Hypercalcemia Anytime During Treatment
Hypercalcemia was defined as at least 1 corrected calcium \> 11.5 mg/dL or at least 2 consecutive corrected calcium \>= 11.0 mg/dL.
Time frame: Baseline and the last 3 weeks (Weeks 11, 12, and 13) for iPTH and anytime during the 12-week treatment period for hypercalcemia
Number of Occurrences of iPTH Control, Defined as >=50% Reduction in iPTH From Baseline
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Site Ref # / Investigator 53792
Matsumoto, Japan
Site Ref # / Investigator 53784
Mito, Japan
Site Ref # / Investigator 53796
Nagasaki, Japan
Site Ref # / Investigator 53795
Osaka, Japan
Site Ref # / Investigator 21561
Sapporo, Japan
Site Ref # / Investigator 53789
Tokyo, Japan
Site Ref # / Investigator 53790
Tokyo, Japan
...and 4 more locations
Time frame: Over the 12-week treatment period
Number of Occurrences of iPTH Control, Defined as Within the Target Range of 60-180 pg/mL of iPTH
Time frame: Over the 12-week treatment period