Examination of paricalcitol compared to maxacalcitol in chronic kidney disease patients with secondary hyperparathyroidism under hemodialysis

Phase 2 open study Exploratory examination of efficacy and safety of paricalcitol injection and maxacalcitol injection in chronic kidney disease subjects receiving hemodialysis with secondary hyperparathyroidism

Status

Unknown

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080220874

Enrollment

Registered

2009-10-06

Start date

2009-10-06

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 hyperparthyroidism

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: CKD patients with iPTH >=300pg/mL, adjusted Ca 8.4<= - <10.2 mg/dL, P <=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 a >=50% reduction in intact parathyroid hormone from baseline to the average of the last 3 weekts The incidence rate of hypercalcemia The incidence rate of hyperphosphatemia	—

Secondary

Measure	Time frame
The proportion of subjects with intact parathyroid hormone within target range of 60-180 pg/mL, based on the last 3 weeks Frequency of intact parathyroid hormone control (>=50% reduction in intact parathyroid hormone from baseline) Frequency of intact parathyroid hormone control (target range of 60-180 pg/mL of iPTH)	—

Outcome results

None listed

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