Tokyo, July 9 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058405) titled 'A Study on the Effects of Medicinal Mouthwash Use on Oral Bacterial Species in Patients with Chronic Glomerulonephritis' on July 9.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Self control
Primary Sponsor:
Institute - The University of Osaka
Condition:
Condition - IgA nephropathy, Membranous nephropathy, Lupus nephritis, Focal segmental glomerulosclerosis (FSGS)
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This study aims to investigate whether the use of ConCool F, a medicated mouthwash, by patients with chronic kidney disease (CKD) not only reduces oral bacteria but also has the potential to decrease proteinuria.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Gurgling with mouthwash for 1 years
Eligibility:
Age-lower limit - Not applicable
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Patients receiving care at the Department of Nephrology, Seirei Hamamatsu Hospital, or Department of General Internal Medicine, Hyogo Medical University. Men and women aged 20 years or older who have been diagnosed with IgA nephropathy, membranous nephropathy, lupus nephritis, or focal segmental glomerulosclerosis, and who have proteinuria of 0.3 g/gCr or more on two consecutive occasions and an estimated glomerular filtration rate (eGFR) of 25 mL/min/1.73 m2 or more.
Key exclusion criteria - Patients with IgA vasculitis will be excluded. Patients with suspected secondary IgA nephropathy, such as those with rheumatoid arthritis or Crohn's disease, will also be excluded. Patients with HbA1c 6.5% or more or those receiving antidiabetic medications other than SGLT2 inhibitors will be excluded. If the dosage of steroids or immunosuppressive drugs is increased during the period, the patient will be excluded from the study.
Target Size - 80
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2025 Year 01 Month 30 Day
Date of IRB - 2025 Year 03 Month 31 Day
Anticipated trial start date - 2025 Year 04 Month 08 Day
Last follow-up date - 2027 Year 04 Month 08 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066772
Disclaimer: Curated by HT Syndication.