Evaluation of efficacy and safety of active vitamin D treatment for secondary hyperparathyroidism in patients on maintenance hemodialysis; competitive study

Evaluation of efficacy and safety of active vitamin D treatment for secondary hyperparathyroidism in patients on maintenance hemodialysis; competitive study - Randomized clinical trial with alfacalcidol versus maxacalcitol

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001656

Enrollment

Registered

2009-01-25

Start date

2008-06-01

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(SHPT)

Interventions

affacalcidol maxacalcitol

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Renal dysfunction: end-stage chronic kidney disease, require maintenance dialysis due to renal dysfunction 2) Expected survival time is more than 6 months 3)Fully informed consent was obtained 4)Intact PTH level 180pg/mL-500pg/mL 5)Serum P level 3.5-7.0mg/dL 6)Serum adjusted Ca 8.4-10.5mg/dL

Exclusion criteria

Exclusion criteria: 1) Malignancy,malnutrition, active inflammatory or infectious disease 2)Severe heart failure and liver dysfunction 3)Pregnancy, during breast-feeding 4)Patients with allergy to affacalcidol and maxacalcitol 5)Primary hyperparathyroidism patients 6)Aluminum and Fe associated bone disease patients 7)Post parathyroidectomy patients, patients received percutaneous ethanol or vitamin D injection 8) Judged inappropriate for this study by the physicians 9)Parients who were recruited another clinical trial within 3 months

Design outcomes

Primary

Measure	Time frame
The percentage achievement of recommendation value (60-180pg/mL) of intact parathyroid hormone(PTH).	—

Countries

Japan

Outcome results

None listed

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