AYD001 Phase III Clinical Trial

JRCT ID: jRCT2031210570

Registered date:21/01/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Patients with chronic renal failure undergoing hemodialysis
• Date of first enrollment: 01/11/2021
• Target sample size: 60
• Study type: Interventional

Intervention(s)

At the time of use, add 26 volumes of water to 1 volume of Agent B of AYD001 to dilute it, and add 1 volume of Agent A to 34 volumes of this diluted solution to dilute it.
The dose varies depending on the dialysis time, but usually 150 to 300 L of perfusate is used at a time.

Outcome(s)

• Primary Outcome: Correction of azotemia (BUN, Cre, and UA)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 90age old
• Gender: Both

Include criteria

(1) Patients undergoing hemodialysis for 3 to 5 hours per session, 3 times a week at the time of informed consent.
(2) Patients aged 20 to less than 90 years old.
(3) Patients providing written informed consent about participation in this clinical study

Exclude criteria

(1) Patients within 26 weeks of initiating hemodialysis at the time of informed consent
(2) Patients with severe hepatic function impairment
(3) Patients with severe heart disease
(4) Patients with severe respiratory disorder

Related Information

• Primary Sponsor: Asaoka Kuniharu