The comparison of calcimimetics

JRCT ID: jRCTs051190014

Registered date:09/05/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Chronic kidney disease
• Date of first enrollment: 04/12/2017
• Target sample size: 300
• Study type: Interventional

Intervention(s)

Arm A: According to the clinical practice guideline for the management of chronic kidney disease-meneral and bone disease (JSDT 2012), treated with intravenous calcimimetics (etelcalcetide) for 1 year.
Arm B: According to the clinical practice guideline for the management of chronic kidney disease-meneral and bone disease (JSDT 2012), treated oral calcimimetics (cinacalcet) for 1 year.

Outcome(s)

• Primary Outcome: Achievement ratio for target levels of PTH, Ca, and P.
• Secondary Outcome: 1) Bone metabolism marker. 2) Bone density. 3) Intestinal bacteria. 4) Arteriosclerosis index. 5) Drugs. 6) Anemia and iron-related factor. 7) The taking medicine situation. 8) Symptom. 9) Medical economic effect.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Maintenance hemodialysis patients with secondary hyperparathyroidism (int-PTH>240 pg/mL)
• Exclude criteria: Patients with sever heart failure (>NYHA III),liver dysfunction, respiratory failure, and malignant tumor.

Related Information

• Primary Sponsor: Kuragano Takahiro
• Source(s) of Monetary Support: ONO PHARMACEUTICAL CO., LTD,ONO PHARMACEUTICAL CO., LTD
• Secondary ID(s): UMIN000029000