An active-controlled, randomized study of K-LA5 in patients with chronic renal failure

Phase 3

Completed

• Conditions: Patients with chronic renal failure undergoing hemodialysis

• Registration Number: JPRN-jRCT2080223080
• Lead Sponsor: FUSO Pharmaceutical Industries, Ltd.

Brief Summary

The effects of K-LA5 were comparable to K-4 with the exception of adjusted Ca. The incidence of adverse events did not differ between the two agents, and no adverse reactions were observed for K-LA5; thus, K-LA5 was considered to have a similar safety profile to that of K-4.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-15
• Study Completion: 2016-12-01
• Results First Posted: 2020-12-10
• Last Update Posted: 2023-10-17

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 131

Inclusion Criteria

(1) Patients with chronic renal failure undergoing hemodialysis for 3 to less than 6 hours per session, 3 times a week, in the last week before the period of pre-observation
(2) Patients aged 20 to 80 years old at the time of informed consent
(3) Patients providing written informed consent about participation in this clinical study

Exclusion Criteria

(1) Patients within 12 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
(5) Female patients who are pregnant, lactating, or who have the possibility of pregnancy which cannot be denied by quantitative hCG blood test at the time of enrollment and allocation, or female patients who cannot prevent conception from the time of informed consent through the period of post-observation
(6) Patients participated in another clinical study within 12 weeks before the time of informed consent
(7) Patients judged by the investigator or sub-investigator to be inadequate for this study due to any other reasons

Study & Design

• Study Type: Interventional
• Study Design: Not specified