臨床研究等提出・公開システム

Cross-over study of PDLYMT in chronic kidney disease (CKD) patients undergoing hemodialysis therapy

Cross-over study of PDLYMT in chronic kidney disease (CKD) patients undergoing hemodialysis therapy

53

There were no obvious imbalances in baseline patient characteristics between groups.

Of 53 patients (27 patients in group A, 26 patients in group B) enrolled in this clinical study, 52 patients received study drug. Of these, 50 patients were included in the primary outcome analysis group as FAS, excluding 2 cases that were discontinued during the pre-observation period.

The incidence of adverse events was 28.6 % (14/49) for PDLYMT and 28.0 % (14/50) for LYMPACK TA3 (TA3) during the crossover period. Serious adverse events were observed in 1 patient during the PDLYMT period and in 3 patients during the TA3 period, all were unrelated to study drug.

For all uremic substances (BUN, Cre, and UA), the proportion in which the removal rate of PDLYMT deviated from the tolerance interval was below the pre-defined limit of 10%.

It was confirmed that there was no remarkable difference in the corrective effect on serum electrolytes (Na, K, Ca, and Mg) and blood acid-base balance (blood HCO3-) between PDLYMT and TA3. Besides, PDLYMT tended to have a lower post-dialysis serum Ca level and a higher post-dialysis serum Mg level compared with TA3, reflecting the change in the composition of the formulation.

It was shown that PDLYMT has a similar effect on removing uremic substances to TA3, and that PDLYMT can correct the serum electrolytes and blood acid-base balance within a clinically appropriate range, reflecting the composition of this drug. In addition, there was no difference in the incidence of adverse events between PDLYMT and TA3, indicating that PDLYMT can be used safely in dialysis treatment as well as TA3.

No

NIPRO CORPORATION

3023, Nojicho, Kusatsu, Shiga, Japan

NIPRO CORPORATION

3023, Nojicho, Kusatsu, Shiga, Japan

+81-77-564-9467

completed

April. 13, 2020

Interventional

A multicenter, two-treatment cross-over study

treatment purpose

3

- Patients providing written informed consent about participation in this clinical study
- Patients aged 20 to 84 years old at the time of informed consent
, etc.

- Patients within 3 months of initiating hemodialysis at the time of informed consent
- Patients who find it difficult to undergo HD stably during the entire duration of this study
- Patients who are pregnant or who have the possibility of pregnancy at the time of informed consent
- Patients participating in clinical studies of other drugs, medical devices, etc. at the time of informed consent for this study
- Patients who may not be able to be evaluated as described in the protocol due to serious disease
- Patients judged by the investigator or sub-investigator to be inadequate for this study
, etc.

Both

CKD patients undergoing hemodialysis therapy

investigational material(s)
Generic name etc : PDLYMT
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 : LYMPACK TA3
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
[Efficacy]
Reduction ratio

safety
efficacy
confirmatory
[Efficacy]
Correction of serum electrolytes and blood acid-base balance, etc.
[Safety]
Adverse event, etc.

Feb. 01, 2020