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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223080

Enrollment

120

Registered

2016-01-15

Start date

2016-01-12

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with chronic renal failure undergoing hemodialysis

Interventions

investigational material(s) Generic name etc : K-LA5 INN of investigational material : - Therapeutic category code : 341 Agents for artificial kidney dialysis Dosage and Administration for Investigati

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
efficacy confirmatory (1) Correction of azotemia (BUN, Cre, and UA) (2) Correction of serum electrolytes (Na, K, adjusted Ca, and Mg) (3) Correction of blood acid-base balance (HCO3-)	—

Secondary

Measure	Time frame
efficacy (1) Temporal change in azotemia (BUN, Cre, and UA) (2) Temporal change in serum electrolytes (Na, K, Cl, total Ca, adjusted Ca, iCa, Mg, and Pi) (3) Temporal change in blood acid-base balance (HCO3-, pH) (4) Evaluation of removal status (Kt/V, n-PCR) of hemodialysis volume (small molecular substances) (5) Temporal change in blood pressure (SBP, DBP, and MBP) and pulse (6) Temporal change in acetic acid concentration (7) Maintenance of blood glucose safety (1) Adverse events (2) Abnormal change in laboratory values (3) Temporal change in laboratory values (4) Temporal change in vital signs	—

Measure

Time frame

efficacy (1) Temporal change in azotemia (BUN, Cre, and UA) (2) Temporal change in serum electrolytes (Na, K, Cl, total Ca, adjusted Ca, iCa, Mg, and Pi) (3) Temporal change in blood acid-base balance (HCO3-, pH) (4) Evaluation of removal status (Kt/V, n-PCR) of hemodialysis volume (small molecular substances) (5) Temporal change in blood pressure (SBP, DBP, and MBP) and pulse (6) Temporal change in acetic acid concentration (7) Maintenance of blood glucose safety (1) Adverse events (2) Abnormal change in laboratory values (3) Temporal change in laboratory values (4) Temporal change in vital signs

—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026