CKD CKD
Conditions
Interventions
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, 2
then the dosage will be increased to 2 caps daily for 1 week, if tolerable, 1) age >= 75 years old and body weight = 75 years old and body weight > 50 Kg or 2) age < 75 years old, 3 caps (75 mg) will
Sponsors
Uchinoumi Hitoshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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 =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
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in daily urinary volume, urinary sodium excretion, urinary potassium excretion, urinary chloride excretion, eGFR, creatinine clearance (CCr) from baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Contacts
Public ContactHitoshi Uchinoumi
Yamaguchi University
Outcome results
None listed