臨床研究等提出・公開システム

An Active-controlled, Randomized, Cross-over study of K-LA5

An Active-controlled, Randomized, Cross-over study of K-LA5

55

Of 55 FAS patients, the proportion of men was 61.3% (19/31) in group A (test-lead group), 79.2% (19/24) in B group (control-lead group), and that of women was 38.7% (12/31) in group A, 20.8% (5/24) in group B. The mean age (SD) was 60.5 (13.8) years in group A, 63.6 (11.7) years in group B.

Of 55 patients (31 patients in group A, 24 patients in group B) enrolled in this clinical study, a total of 3 patients were not completed and 52 patients (30 patients in group A, 22 patients in group B) were completed after enrollment.

The incidence of adverse events was 35.2% (19/54) for K-LA5 and 46.3% (25/54) for Kindaly AF-4 (K-4) in SAS. Adverse reactions were observed for neither K-LA5 nor K-4. 1 serious adverse event occurred in 1 subject for K-LA5 and 2 serious adverse events occurred in 2 subjects for K-4, all of which were not related to the study drug.

Concerning the correction of azotemia (BUN, Cre, and UA), since the removal rate of K-LA5 was 90% or more in the tolerance interval for all items, it was shown that K-LA5 was similar to K-4.

It was confirmed that K-LA5 was not remarkably different from K-4 in the correction of serum electrolytes (Na, K, adjusted Ca, and Mg) and the correction of blood acid-base balance (HCO3-).Comparing the change in serum electrolytes in the duration of administration and dialysis, K, Cl, and Mg concentration increased and iCa concentration decreased for K-LA5 compared with K-4. Electrolytes and blood gas including items with significant differences showed effects in line with differences in composition.

Evaluation of the elimination of substances related to azotemia (BUN, Cre, UA) as the primary endpoint showed K-LA5 was similar to K-4. 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.

Jan. 10, 2021

https://mol.medicalonline.jp/library/journal/abstract?GoodsID=aa9syrsc/2021/007001/001&name=0002-0042j&UserID=1200001753-18,https://www.iyaku.info/magazine/?ca3=70&ca4=1&ca=2021&ca2=1&sk=&x=90&y=17&sf=1#st

No

FUSO Pharmaceutical Industries, Ltd.

rinsyo@fuso-pharm.co.jp

FUSO Pharmaceutical Industries, Ltd.

rinsyo@fuso-pharm.co.jp

completed

May. 02, 2018

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.

confirmatory
efficacy
Correction of azotemia (BUN, Cre, and UA)

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

April. 12, 2018