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

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

131

Of 125 PPS patients, the proportion of men was 60.0% (39/65) in group A (test-lead group), 68.3% (41/60) in B group (control-lead group), and that of women was 40.0% (26/65) in group A, 31.7% (19/60) in group B. The mean age (SD) was 63.8 (9.7) years in group A, 63.8 (11.4) years in group B.

Of 131 patients (66 patients in group A, 65 patients in group B) enrolled in this clinical study, a total of 5 patients were not completed and 126 patients (65 patients in group A, 61 patients in group B) were completed after enrollment.

The incidence of adverse events was 50.0% (64/128) for K-LA5 and 54.3% (69/127) for Kindaly AF-4 (K-4) in SAS. Adverse reactions were not observed for K-LA5, and 1 event of eczema occurred in 1 subject for K-4. 3 serious adverse events occurred in 3 subjects for both K-LA5 and K-4, all of which were not related to the study drug.

Among the correction of azotemia (BUN, Cre, and UA), correction of serum electrolytes (Na, K, adjusted Ca, and Mg), and correction of blood acid-base balance (HCO3-), since the lower limit of the two-sided 95% CI of the difference between administered drugs for the correction rates of adjusted Ca levels was below the non-inferiority margin, non-inferiority of K-LA5 to K-4 could not be verified.

In the change of the removal rate of azotemia (BUN, Cre, and UA), the removal rate of azotemia of K-LA5 was equivalent to that of K-4. Comparing the change in serum electrolytes and blood acid-base balance in the duration of administration and dialysis, K, Mg, and Cl concentration before dialysis increased and HCO3- concentration decreased for K-LA5 compared with K-4. In addition, the change in acetic acid concentration after dialysis (increment) was almost halved. In the change of blood glucose before and after dialysis, it was shown that the degree of decrement of blood glucose by dialysis in the fasting state was moderated. In addition, it was indicated that the change of the Ca concentration before and after the dialysis decreased.

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.

Dec. 10, 2020

https://mol.medicalonline.jp/library/journal/abstract?GoodsID=aa9syrsc/2020/006912/002&name=1398-1439j&UserID=1200001753-18,https://www.iyaku.info/magazine/?ca3=69&ca4=12&ca=2020&ca2=12&sk=&x=70&y=23&sf=1#st

No

FUSO Pharmaceutical Industries, Ltd.

rinsyo@fuso-pharm.co.jp

FUSO Pharmaceutical Industries, Ltd.

rinsyo@fuso-pharm.co.jp

completed

Jan. 12, 2016

Interventional

A multicenter, open-label, randomized, active-controlled, two-period two-treatment cross-over study

treatment purpose

3

(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

Both

Patients with chronic renal failure undergoing hemodialysis

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 Investigational material : Used as perfusate in hemodialysis with bicarbonate-based dialysis fluid delivery system.

control material(s)
Generic name etc : Kindaly AF-4
INN of investigational material : -
Therapeutic category code : 341 Agents for artificial kidney dialysis
Dosage and Administration for Investigational material : Used as perfusate in hemodialysis with bicarbonate-based dialysis fluid delivery system.

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-)

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

Dec. 25, 2015