Comparison of efficacy and safety of paricalcitol injection with maxacalcitol injection in adult Japanese chronic kidney disease subjects receiving hemodialysis with secondary hyperparathyroidism

Phase III Confirmatory Study ; Comparison of efficacy and safety of paricalcitol injection with maxacalcitol injection in adult Japanese chronic kidney disease subjects receiving hemodialysis with secondary hyperparathyroidism

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221462

Enrollment

252

Registered

2011-05-18

Start date

2011-05-18

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Secondary hyperparathyroidism

Interventions

investigational material(s) Generic name etc : ABT-358(paricalcitol) INN of investigational material : Paricalcitol Therapeutic category code : 311 Vitamin A, D and preparations Dosage and Administrat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adult Chronic Kidney Disease (CKD) Stage 5 patient with -intact parathyroid hormone (iPTH) greater than or equal to 300pg/mL -adjusted normalized serum total calcium (Ca) greater than or equal to 8.4 - less then 10.2 mg/dL -serum phosphorus (P) less than or equal to 6.5 mg/dL

Exclusion criteria

Exclusion criteria: Patients taking drugs that affect iPTH, calcium or bone metabolism

Design outcomes

Primary

Measure	Time frame
The proportion of subjects with intact parathyroid hormone (iPTH) in the target range of 60-180 pg/mL, based on the average of the last 3 weeks without hypercalcemia during treatment phase	—

Secondary

Measure	Time frame
The proportion of subjects with greater than or equal to 50% reduction in intact parathyroid hormone (iPTH) from baseline to the average of the last 3 weeks without hypercalcemia during treatment phase The proportion of subjects with intact parathyroid hormone (iPTH) in the target range of 60-180 pg/mL based on the average of the last 3 weeks The proportion of subjects with a greater than or equal to 50% reduction in intact parathyroid hormone (iPTH) from baseline to the average of the last 3 weeks	—

Measure

Time frame

The proportion of subjects with greater than or equal to 50% reduction in intact parathyroid hormone (iPTH) from baseline to the average of the last 3 weeks without hypercalcemia during treatment phase The proportion of subjects with intact parathyroid hormone (iPTH) in the target range of 60-180 pg/mL based on the average of the last 3 weeks The proportion of subjects with a greater than or equal to 50% reduction in intact parathyroid hormone (iPTH) from baseline to the average of the last 3 weeks

—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026