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

JRCT ID: jRCTs061220072

Registered date:02/12/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: CKD
• Date of first enrollment: 13/12/2022
• Target sample size: 5
• Study type: Interventional
• Intervention(s): Single-dose administration of dantrolene 25 mg

Outcome(s)

• Primary Outcome: Pharmacokinetics
• Secondary Outcome: Safety (Adverse events)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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

Exclude criteria

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

Related Information

• Primary Sponsor: Uchinoumi Hitoshi