Tokyo, July 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062010) titled 'A Crossover Trial Comparing CARBOSTAR 2P fo Dialysis and KINDALY Hemodiakysis Agents 5E in Patients on Chronic Maintenance Dialysis' on June 30.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Active
Primary Sponsor:
Institute - KYDNEY CLINIC SETAGAYA,Hemodyalisis,Sinya Suganuma
Condition:
Condition - Chronic Maintenance Dialysis Patients
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - We will compare this solution with Kindley Dialysis Solution No. AF5, which is adjusted to a K concentration of 2.3 mEq/L, to evaluate its effectiveness in correcting serum potassium levels and electrolyte imbalances. We will also evaluate nutritional status and changes in the patients condition during dialysis as secondary endpoints.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - CARBOSTAR 2P for Dialysis
Interventions/Control_2 - KINDALY Hemodialysis Agents 5E
Eligibility:
Age-lower limit - 30
years-old
Gender - Male and Female
Key inclusion criteria - Patients from whom informed consent can be obtained
Patients undergoing pre-diluted online hemodiafiltration with a replacement fluid volume of 10 L/h or more
Patients undergoing intermittent replacement HDF
Key exclusion criteria - Patients with a history of acetic acid intolerance for whom the use of acetic acid-containing dialysate is not recommended
Patients with severe liver, heart, or lung dysfunction, as determined by the attending physician
Patients presenting with uncontrolled inflammation
Pregnant or breastfeeding patients
Patients deemed unsuitable for participation in this study by the attending physician
Target Size - 10
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 05 Month 30 Day
Date of IRB - 2026 Year 06 Month 21 Day
Anticipated trial start date - 2026 Year 07 Month 01 Day
Last follow-up date - 2027 Year 05 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070950
Disclaimer: Curated by HT Syndication.
