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A single-dose clinical study to evaluate the pharmacokinetics of dantrolene sodium hydrate in patients with moderately to severely reduced kidney function (SHO-IN CKD PK study)

A pharmacokinetics study of dantrolene sodium hydrate in patients with moderately to severely reduced kidney function

5

The mean age was 75 years, 20% was female, 80% had hypertension, 20% had diabetes mellitus, 60% had chronic heart failure, and estimated glomerular filtration rate (eGFR) was 36.9, and brain natriuretic peptide (BNP) level was 110.9.

None

None

When dantrolene sodium hydrate (dantrolene) was administered orally at a 25 mg in CKD patients, peak plasma concentration (Cmax) was 0.20 microgram/mL and time to maximum concentration (Tmax) was 8 hours. According to the drug interview form of dantrolene sodium hydrate, when dantrolene was administered orally at a 25 mg In healthy adult, Cmax was 0.27 microgram/mL, and Tmax was 4 hours.

When dantrolene was administered orally at a 25 mg in CKD patients with mean eGFR 36.9, Cmax was 0.20 microgram/mL and Tmax was 8 hours in this study. There was no difference in Cmax between CKD patients and healthy adult (the data from the drug interview form of dantrolene sodium hydrate). No adverse events including laboratory abnormality were observed in this study.

Dec. 01, 2023

No

No

https://jrct.mhlw.go.jp/latest-detail/jRCTs061220072

Uchinoumi Hitoshi

Yamaguchi University

1-1-1 Minamikogushi, Ube, Yamaguchi

huchi@yamaguchi-u.ac.jp

Uchinoumi Hitoshi

Yamaguchi University

1-1-1 Minamikogushi, Ube, Yamaguchi

+81-836-22-2248

huchi@yamaguchi-u.ac.jp

Complete

Dec. 02, 2022

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

other

1) Chronic Kidney Disease (CKD)
2) Estimated glomerular filtration rate (eGFR): 25-45 mL/min/1.73m2
3) Age >= 20 years old
4) Male and female
5) Inpatient of Yamaguchi university hospital
6) No acute renal failure, acute decompensated heart failure, or lethal arrythmia
7) Written consent to participate in the study from the individual

1) Patients receiving therapy with immune suppressive drugs (e.g. prednisolone >=5 mg/day or equivalent), who primary investigator and investigators consider as unstable condition of the disease.
2) Use of potassium adsorbents within 2 months prior to enrollment
3) Patients with drug-induced renal dysfunction
4) Patients who continuously receive hemodialysis and peritoneal dialysis or are planned to receive these renal replacement therapy
5) History of renal transplantation, or is planned to receive this surgery after enrollment
6) Uncontrollable Diabetes mellitus, hypertension or hyperthyroidism
7) Patients with COPD and severe respiratory dysfunction
8) Patients diagnosed with myasthenia gravis
9) Patients with severe liver dysfunction
10) Patients with ileus
11) Patients who could not receive oral medication
12) History of allergy and hypersensitivity for dantrolene
13) Pregnant or potentially pregnant women or breastfeeding
14) Patients with severe inflammatory disease such as sepsis and pneumonia etc.
15) Patients with active cancer

Both

CKD

Single-dose administration of dantrolene 25 mg

CKD

Single-dose administration of dantrolene 25 mg

Pharmacokinetics

Safety (Adverse events)

+81-836-22-2428

Nov. 09, 2022

none