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

Not Applicable

• Conditions: CKD

• Registration Number: JPRN-jRCTs061230094
• Lead Sponsor: chinoumi Hitoshi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-29
• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 15

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 <=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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified