A clinical study to evaluate the effect of dantrolene sodium hydrate on kidney function and albuminuria in patients with CKD

JRCT ID: jRCTs061230094

Registered date:29/01/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: CKD
• Date of first enrollment: 01/02/2024
• Target sample size: 15
• Study type: Interventional

Intervention(s)

After obtaining informed consent, dantrolene is administrated for 4 weeks.
After giving the drugs for 4 weeks, a 8-week follow-up will confirm the safety after stopping the drugs.
Dantrolene (1 cap, 25 mg) will be administered daily for 1 week; then the dosage will be increased to 2 caps daily for 1 week, if tolerable, 1) age >= 75 years old and body weight <= 50 Kg, 2 caps (50 mg) daily is max dosage. Finally, if tolerable and 2) age >= 75 years old and body weight > 50 Kg or 2) age < 75 years old, 3 caps (75 mg) will be administered daily according to manufacturer instructions for the drug. If the 3-cap dose is not tolerable, daily administration of 2 caps daily will continue, but administration of 1 cap (25 mg) daily will not be continued.

Outcome(s)

• Primary Outcome: Changes in daily urinary volume, urinary sodium excretion, urinary potassium excretion, urinary chloride excretion, eGFR, creatinine clearance (CCr) from baseline.
• Secondary Outcome: Changes in UACR, urinary type IV collagen, urinary FDP (fibrin/fibrinogen degradation products), urinary podocalyxin, urinary L-type fatty acid binding protein (L-FABP) from baseline.

Key inclusion & exclusion criteria

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

Include criteria

1. Chronic Kidney Disease (CKD) patients who receive treatment according Evidence-based Clinical Practice Guideline for CKD 2018.
2. Female or male aged >=20 years at the time of consent
3. eGFR >=25 and <=45 mL/min/1.73m2 at visit 0 or UACR >=200 and <=5000 mg/gCr at visit 0
4. Provision of signed informed consent prior to any study specific procedures
5. Out-patient of Yamaguchi university hospital

Exclude criteria

1) Patient who should receive 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) History of receiving therapy with immune suppressive drugs (e.g. prednisolone >= 5 mg/day or equivalent) within 3 months of obtaining informed consent
3) UPCR (urinary protein-to-creatinine ratio: g/gCr) measured from spot urine sample >= 3.0 at screening period
4) Acute renal failure
5) Drug-induced renal dysfunction
6) Continuously receiving hemodialysis and peritoneal dialysis or is planned to receive these renal replacement therapy
7) History of renal transplantation, or is planned to receive this surgery during the present study
8) Uncontrollable diabetes mellitus, hypertension or hyperthyroidism
9) Receiving therapy with acute heart failure or lethal arrhythmia
10) COPD and severe respiratory dysfunction
11) Diagnosed with myasthenia graves
12) Severe liver dysfunction
13) Ileus
14) Patient who could not receive oral medication
15) History of allergy and hypersensitivity for dantrolene
16) Pregnant or potentially pregnant women or breastfeeding
17) History of acute coronary syndrome, stroke, transient ischemic attack within 3 months prior to obtaining informed consent
18) Cardiac, carotid, or other major CV surgery (surgical/transcatheter) was performed within 3 months of obtaining informed consent or is planned to receive these surgery within the 3 months after obtaining informed consent
19) Severe inflammatory disease such as sepsis and pneumonia etc.
20) Active cancer
21) Patient who primary investigator and investigators consider as unsuitable for the present study

Related Information

• Primary Sponsor: Uchinoumi Hitoshi