Vitamin D receptor activator versus intravenous calcimimetics in the treatment of renal patients with secondary hyperparathyroidism: a randomized clinical trial (VICTORY)

Vitamin D receptor activator versus intravenous calcimimetics in the treatment of renal patients with secondary hyperparathyroidism: a randomized clinical trial (VICTORY) - Vitamin D receptor activator versus intravenous calcimimetics in the treatment of renal patients with secondary hyperparathyroidism: a randomized clinical trial (VICTORY)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000030636

Enrollment

400

Registered

2018-01-01

Start date

2018-02-01

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

Maintenance hemodialysis patients with secondary hyperparathyroidism

Interventions

Etelcalcetide (intravenous), thrice weekly, for 12 months. Starting dose, 5 mg (thrice weekly). Dose adjustment according to the package insert. Maxacalcitol (intravenous), thrice weekly, for 1

500 pg/mL

10 microg (thrice weekly) if intact PTH &gt

= 500 pg/mL. Dose adjustment according to the package insert.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Men and women, age >= 20 and < 80 years 2) Duration of dialysis >= 90 days 3) Serum intact PTH >= 241 pg/mL and corrected Ca >= 8.4 mg/dL, 4) Treated 3 times a week of hemodialysis 5) No treatment with etelcalcetide, cinacalcet, intravenous or oral vitamin D receptor activator in the preceding four weeks or longer

Exclusion criteria

Exclusion criteria: 1) History of parathyroid intervention or fracture in the preceding 12 weeks 2) History of myocardial infarction, stroke, lower limb amputation, or revascularization for coronary artery or lower extremity in the preceding 12 weeks 3) Presence of heart failure of NYHA class III or IV 4) Presence of respiratory failure of SpO2 < 90% 5) Patients with severe illness with life expectancy of less than 1 year 6) Liver dysfunction with elevated AST or ALT exceeding 3 x upper limit of normal 7) Pregnant, lactating women or women who plan to be pregnant 8) History of allergy to etercalcetide and/or maxacalcitol 9) Patients treated with bisphosphonate and/or denosumab

Design outcomes

Primary

Measure	Time frame
Change in T50 (delta T50) at 12 month from baseline	—

Secondary

Measure	Time frame
1) Changes in T50 (delta T50) at 3 and 6 month from baseline 2) Proportions of participants who achieve the target ranges of serum Ca, P and intact PTH, respectively, by the JSDT CKD-MBD guideline (2012) at 3, 6 and 12 month 3) Proportions of participants who have the reduction of intact PTH level by 30% or greater at 3, 6 and 12 month 4) Ca-P product at 3, 6 and 12 month 5) Serum Fetuin A and FGF23 levels at 3, 6 and 12 month 6) Subjective symptoms (nausea, vomiting, cacogeusia, diarrhea, and jitteriness) 7) Hypocalcemia and hypercalcemia requiring cessation of the study drug 8) Severe adverse events in 12 months (all-cause death, hospitalization due to cardiovascular event, infection, and others) 9) Falls 12 months 10) Change in hand grip strength at 12 month from baseline 11) Changes in ability of daily living and cognitive function at 12 month from baseline	—

Measure

Time frame

1) Changes in T50 (delta T50) at 3 and 6 month from baseline 2) Proportions of participants who achieve the target ranges of serum Ca, P and intact PTH, respectively, by the JSDT CKD-MBD guideline (2012) at 3, 6 and 12 month 3) Proportions of participants who have the reduction of intact PTH level by 30% or greater at 3, 6 and 12 month 4) Ca-P product at 3, 6 and 12 month 5) Serum Fetuin A and FGF23 levels at 3, 6 and 12 month 6) Subjective symptoms (nausea, vomiting, cacogeusia, diarrhea, and jitteriness) 7) Hypocalcemia and hypercalcemia requiring cessation of the study drug 8) Severe adverse events in 12 months (all-cause death, hospitalization due to cardiovascular event, infection, and others) 9) Falls 12 months 10) Change in hand grip strength at 12 month from baseline 11) Changes in ability of daily living and cognitive function at 12 month from baseline

—

Countries

Japan

Contacts

Public ContactShinya Nakatani

Osaka City University Graduate School of Medicine Department of Metabolism, Endocrinology and Molecular Medicine

m2026719@med.osaka-cu.ac.jp06-6645-3806

Outcome results

None listed

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