Upacicalcet on coronary calcification measured in patients undergoing hemodialysis(UPCOMING)

JRCT ID: jRCTs041220126

Registered date:25/01/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Secondary hyperparathyroidism (SHPT)
• Date of first enrollment: 19/05/2022
• Target sample size: 250
• Study type: Interventional

Intervention(s)

Early intervention group
Upacicalcet + low dose of active vitamin D
(Active vitamin D may be increased, decreased, discontinued, or not administered within the doses specified in the study)

Conventional therapy group
Administration of active vitamin D
(The dosage of active vitamin D may be increased freely within the limits of the package insert)

Outcome(s)

• Primary Outcome: The amount of change in log-transformed CACS (volume) from baseline (observation period) to 52 weeks (12 months) after study treatment.

Secondary Outcome

(1) CACS
The amount of change in log-transformed CACS (Agatston score) from baseline (observation period) to 52 weeks (12 months) after study treatment.
The proportion of patients with increasing greater than 15% for CACS (volume and Agatston score) (comparison of observation period vs. after 52 weeks from starting of study treatment [12 months]).
(2) Total deaths during the study treatment period (all deaths regardless of cause).
(3) Incidence of major adverse cardiovascular events during the study treatment period.
Major adverse cardiovascular events are defined as cardiovascular death, non-fatal myocardial infarction, unstable angina, heart failure, stroke, and other cardiovascular events requiring hospitalization.
(4) Blood biochemical tests
Phosphorus (P), corrected calcium (Ca), corrected calcium-phosphorus (Ca * P) product, intact FGF23 and intact PTH.
The rate of change and amount of change between baseline (observation period) and at each time point during the study treatment period of above parameters.
(5) Progression of aortic stenosis severity during the study treatment period.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1) Patients who have obtained written consent of their own free will based on full understanding after receiving sufficient explanation prior to participation in this study.
(2) Patients who are at least 18 years old at the time of obtaining consent to participate in this study.
(3) At the time of the informed consent, patients must be scheduled to be on dialysis or have been on dialysis for less than 60 months.
(4) Patients with intact PTH concentration > 240 pg/mL during the observation period.
(5) Patients with serum corrected calcium concentration > 8.4 mg/dL during the observation period.
(6) Patients with CACS >= 30 during the observation period.
(7) Patients who have not received any calcimimetics within 4 weeks prior to enrollment.
(8) Patients who have not changed the dosage or started or stopped administration of active vitamin D within 4 weeks prior to enrollment.

Patients who have received an active vitamin D preparation within 4 weeks prior to enrollment must meet the following conditions.
If the patient is receiving maxacalcitol injection, the dose must be less than or equal to 7.5 ug/week.
If the patient is receiving calcitriol injection, the dose should be less than or equal to 1.5 ug/week.
If the patient is receiving an oral active vitamin D preparation, the dose should be less than or equal to the lower limit specified in the package insert of each preparation.
No use or switching between multiple preparations within 4 weeks prior to enrollment.

Exclude criteria

(1) Patients who have changed the dosage or started or stopped administration any of calcium agents, phosphorus adsorbents, or dyslipidemia drugs within 4 weeks prior to enrollment.
(2) Patients with a history of parathyroid intervention or bone fracture within 12 weeks prior to enrollment.
(3) Patients with any of myocardial infarction, stroke, or lower limb amputation within 12 weeks prior to enrollment.
(4) Patients with a history of coronary artery revascularization (PCI, CABG) .
(5) Patients with heart failure of New York Heart Association (NYHA) cardiac function classification III or higher.
(6) Patients with serious diseases that are judged to have a life expectancy of 1 year or less.
(7) Patients with AST or ALT exceeding 3 times the upper limit of the institutional reference value.
(8) Pregnant women, lactating women, or women who wish to become pregnant within 1 year.
(9) Patients with allergy to Upacicalcet or vitamin D preparations.
(10) Patients who have used bisphosphonates, parathyroid hormone preparations (teriparatide), anti-RANKL monoclonal antibody or anti-sclerostin monoclonal antibody within 6 months prior to enrollment.
(11) Patients who are deemed inappropriate to participate in the study by the principal investigator(s) for reasons other than those listed above.

Related Information

• Primary Sponsor: Inaguma Daijo
• Source(s) of Monetary Support: Sanwa Kagaku Kenkyusho Co., Ltd.