Skip to content

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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs061220072
Enrollment
5
Registered
2022-12-02
Start date
2022-12-13
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CKD CKD

Interventions

Single-dose administration of dantrolene 25 mg

Sponsors

Uchinoumi Hitoshi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

MeasureTime frame
Pharmacokinetics

Secondary

MeasureTime frame
Safety (Adverse events)

Contacts

Public ContactHitoshi Uchinoumi

Yamaguchi University

huchi@yamaguchi-u.ac.jp+81-836-22-2248

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026