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

JRCT ID: jRCTs051180156

Registered date:25/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Maintenance hemodialysis patients with secondary hyperparathyroidism
• Date of first enrollment: 28/02/2018
• Target sample size: 400
• Study type: Interventional
• Intervention(s): Medicine

Outcome(s)

• Primary Outcome: Change 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
• Gender: Both

Include 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, evocalcet, intravenous or oral vitamin D receptor activator in the preceding four weeks or longer

Exclude 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

Related Information

• Primary Sponsor: Shoji Tetsuo
• Source(s) of Monetary Support: ONO PHARMACEUTICAL CO., LTD.
• Secondary ID(s): UMIN000030636