Tokyo, July 31 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058363) titled 'Burden of Bowel Movement Problems Study in Patients with Hemodialysis' on July 31.
Study Type:
Observational
Primary Sponsor:
Institute - Kyowa Kirin Co., Ltd.
Condition:
Condition - End-stage kidney disease
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To reveal patient-reported problems and challenges regarding bowel movement problems in patients with hemodialysis in Japan.
Basic objectives2 - Others
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - A qualitative study
-Patients undergoing outpatient dialysis at Japanese dialysis facilities, aged over 18 years old, and gave informed consent to participation
-Patients feeling about bowel movement problems in their daily living
A quantitative study
-Patients undergoing outpatient dialysis at Japanese dialysis facilities, aged over 18 years old, and gave informed consent to participation
Key exclusion criteria - Patients having structural gastrointestinal diseases
Patients with dementia and psychiatric disorders
Patients using opioids within a month of right before giving informed consent, or at a time of giving informed consent
Patients undergoing chemotherapy within a month of right before giving informed consent, or at a time of giving informed consent
Patients on both hemodialysis and peritoneal dialysis
Patient participating
Patients participating to any clinical trials
Target Size - 212
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 06 Month 19 Day
Date of IRB - 2025 Year 06 Month 19 Day
Anticipated trial start date - 2025 Year 08 Month 01 Day
Last follow-up date - 2026 Year 09 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066717
Disclaimer: Curated by HT Syndication.
