Goreisan Prospective Randomized Evaluation Study

JRCT ID: jRCTs051230192

Registered date:28/02/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Chronic kidney disease
• Date of first enrollment: 09/05/2024
• Target sample size: 130
• Study type: Interventional

Intervention(s)

Goreisan treatment group: subjects will take 2.5 g three times daily (7.5 g/ day) before meal or between meals. The dosage can be adjusted according to age, body weight, or symptoms.
Standard treatment group: only standard treatment.

Outcome(s)

• Primary Outcome: Rate of change in urinary protein-to-creatinine ratio at 24 weeks

Secondary Outcome

1. Urinary protein-to-creatinine ratio (rate of change in urinary protein-to-creatinine ratio at the points other than 24 weeks, proportion of subjects who have over 30% reduction in urinary protein-to-creatinine ratio at any point, and amount of change in urinary protein-to-creatinine ratio at any point)
2. Urinary albumin-to-creatinine ratio (rate of change in urinary protein-to-creatinine ratio, proportion of subjects who have a reduction of at least 30% in urinary protein-to-creatinine ratio at any point, and amount of change in urinary protein-to-creatinine ratio)
3. eGFR (slope, amount and ratio of change in eGFR)
4. Composite kidney outcome (decline of at least 30% from the baseline value in eGFR (2 or more points), doubling of serum creatinine (2 or more points), initiation of chronic dialysis, receiving kidney transplantation, or death due to kidney disease)
5. Urinary L-FABP levels
6. Blood pressure, body weight, and edema
7. QOL assessed by EQ-5D-5L
8. Serum calcium levels and serum phosphorus levels
9. Plasma BNP levels, serum NT-pro BNP levels, and serum troponin I levels
10. Urinaly osmolarity levels, Urinary sodium levels, urinary potassium levels, and urinary chrolide levels
11. Urinary 8-hydroxydeoxyguanosine levels
12. Adverse events during observational period

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Chronic kidney disease and eGFR of >=15 to <60 ml/min/1.73m2 (CKD stage G3 or G4)
2. Urinary protein-to-creatinine ratio >= 0.15 g/gCr
3. Stable dose of SGLT2 inhibitor, RAS inhibitor, diuretic, GLP-1 receptor agonist, or steroid (equivalent to <= 5mg/day of predonisolone) for at least 3 months before registration. Topical, ophthalmic, rectal, intra-anticular, inhaled corticosteroids, and short courses (<= 14 days) of oral/intravenous steroids are allowed.
4. 18 years old or older
5. Ability to take Goreisan
6. Ability to understand the explanation and provide written consent

Exclude criteria

1. Patients undergoing dialysis
2. History of kidney transplantation.
3. Severe hepatic impairment (refer to Grade 3 in CTCAE v5.0 - JCOG)
4. Active malignancy
5. Allergy to Chinese herb or a history of adverse effects due to Chinese herb
6. History of serious allergy, like anaphylactic shock, to or side effect of medications
7. Use of prohibited medications for concomitant use or an investigational medicinal product in the 4 weeks prior to written informed consent
8. Current pregnancy, lactation or women of childbearing potential
9. Patients who are judged to be inappropriate for participation in this study by a local investigator

Related Information

• Primary Sponsor: Fujii Hideki
• Source(s) of Monetary Support: TSUMURA &amp; CO.