An active-controlled, randomized study of K-LA5 in patients with chronic renal failure
- 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
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 131
(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
(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
- Primary Outcome Measures
Name Time Method efficacy<br>confirmatory<br>(1) Correction of azotemia (BUN, Cre, and UA)<br>(2) Correction of serum electrolytes (Na, K, adjusted Ca, and Mg)<br>(3) Correction of blood acid-base balance (HCO3-)
- Secondary Outcome Measures
Name Time Method efficacy<br>(1) Temporal change in azotemia (BUN, Cre, and UA)<br>(2) Temporal change in serum electrolytes (Na, K, Cl, total Ca, adjusted Ca, iCa, Mg, and Pi)<br>(3) Temporal change in blood acid-base balance (HCO3-, pH) <br>(4) Evaluation of removal status (Kt/V, n-PCR) of hemodialysis volume (small molecular substances)<br>(5) Temporal change in blood pressure (SBP, DBP, and MBP) and pulse<br>(6) Temporal change in acetic acid concentration<br>(7) Maintenance of blood glucose<br>safety<br>(1) Adverse events<br>(2) Abnormal change in laboratory values<br>(3) Temporal change in laboratory values<br>(4) Temporal change in vital signs