Secondary Hyperparathyroidism Clinical Trial
Official title:
Late Phase 2 Study of Paricalcitol Injection: Dose-response Study of Paricalcitol Injection in Chronic Kidney Disease Subjects Receiving Hemodialysis With Secondary Hyperparathyroidism (Examination of Initial Dose and Incremental Dose)
The purpose of this study was to investigate the initial dose and dose adjustment range for paricalcitol injection in patients with chronic kidney disease on hemodialysis who have secondary hyperparathyroidism.
This multicenter, randomized, open-label trial consisted of 4 dose-adjustment regimens for
paricalcitol injection (initial doses and dose adjustment ranges were 2 ± 1 µg, 2 ± 2 µg, 4
± 1 µg, and 4 ± 2 µg) and 1 maxacalcitol regimen (initial dose and dose adjustment range was
5 µg ± 2.5 µg or 10 µg ± 2.5 µg) as a reference group. Subjects who met the inclusion
criteria were randomized equally to 1 of the treatment groups with iPTH values at screening
(< 500 pg/mL or ≥ 500 pg/mL) as a dynamic allocation factor. Study drugs were administered 3
times weekly (every other day) from the venous end of the hemodialysis circuit just before
completion of the dialysis session. The initial doses were continued for 2 weeks, followed
by dose adjustments (increase, maintenance, decrease, suspension, or resumption) by 1 µg or
2 µg units for the paricalcitol groups and by 2.5 µg units for the maxacalcitol group based
on iPTH, calcium (adjusted), and phosphorus values every 2 weeks.
Subjects in the paricalcitol groups were to be suspended from treatment if their iPTH value
decreased to < 60 pg/mL in accordance with the guidelines proposed by the Japanese Society
of Dialysis Therapy for the treatment of secondary hyperparathyroidism in chronic dialysis
patients (control goal value of 60-180 pg/mL for iPTH). The dose adjustment criteria based
on iPTH values for the maxacalcitol group were set according to the prescribing information
for maxacalcitol (suspended when iPTH decreased to ≤ 150 pg/mL).
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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