A combination of cinacalcet with maxacalcitol for regression of moderate to advanced secondary hyperparathyroidism in patients on chronic hemodialysis

A combination of cinacalcet with maxacalcitol for regression of moderate to advanced secondary hyperparathyroidism in patients on chronic hemodialysis - Combined therapy of cinacalcet with maxacalcitol for regression of secondary hyperparathyroidism

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001478

Enrollment

Registered

2009-10-25

Start date

2008-04-01

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

High doses of cinacalcet and maxacalcitol

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Chronic dialysis patients of intact PTH from 300 to 1000pg/ml under Ca 8.4-10.0mg/dl and P 3.0-6.0mg/dl

Exclusion criteria

Exclusion criteria: 1) Uncontrolled ischemic heart disease, heart failure, and arrhythmia 2) Stroke within 6 months 3) Peripheral artery didease of Fontaine 3 and 4 4) Severe liver cirrhosis 5) Malignancy within 3 years 6) Uncontrolled phychosis 7) Attendant for other clinical studies within 3 months 8) Pregnant woman or man who wish for baby 9) Unsuitable patients

Design outcomes

Primary

Measure	Time frame
Indication of parathyroidectomy or other intervention therapy by sustained high intact PTH level (>1000 pg/ml)	—

Secondary

Measure	Time frame
1) Difficulty of management of calcium and phosphate by a combination of cinacalcet and maxacalcitol 2) Low iPTH (<30 pg/ml) 3) Adynamic bone 4) Cardiovascular events	—

Countries

Japan

Contacts

Public ContactTatsuo Tsukamoto

Kitano Hospital, The Tazuke Kofukai Medical Institute Division of Nephrology and Dialysis

06-6312-8831

Outcome results

None listed

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