NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs051180156

Registered date:25/03/2019

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

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedMaintenance hemodialysis patients with secondary hyperparathyroidism
Date of first enrollment28/02/2018
Target sample size400
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Medicine

Outcome(s)

Primary OutcomeChange in T50 (delta T50) at 12 month from baseline
Secondary Outcome< Secondary outcome > Change in hand grip strength at 12 month from baseline < Tertiary outcome > Changes in ability of daily living and cognitive function at 12 month from baseline < Other subsidiary outcomes > 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 (allcause death, hospitalization due to cardiovascular event, infection, and others) 9) Falls in 12 months

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum< 80age old
GenderBoth
Include criteria1) 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, evocalcet, intravenous or oral vitamin D receptor activator in the preceding four weeks or longer
Exclude criteria1) 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

Related Information

Contact

Public contact
Name Shinya Nakatani
Address 1-4-3, Asahi-machi, Abeno-ku, Osaka 545-8585 Osaka Japan 545-8585
Telephone +81-6-6645-3806
E-mail m2026719@med.osaka-cu.ac.jp
Affiliation Osaka City University Graduate School of Medicine
Scientific contact
Name Tetsuo Shoji
Address 1-5-7, Asahi-machi, Abeno-ku, Osaka 545-8586 Osaka Japan 545-8586
Telephone +81-6-6645-3930
E-mail t-shoji@med.osaka-cu.ac.jp
Affiliation Osaka City University Hospital