Effects of new dialysate for Japanese dialysis patients (K5) on serum electrolytes, acid-base balance, and calcium mass balance: A prospective multicenter clinical trial.

Effects of new dialysate for Japanese dialysis patients (K5) on serum electrolytes, acid-base balance, and calcium mass balance: A prospective multicenter clinical trial. - the K5 Study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000043714

Enrollment

200

Registered

2021-04-01

Start date

2021-03-01

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

End-stage kidney disease

Interventions

Dialysate potassium 2.3 mEq/L, calcium 2.6 mEq/L, magnesium 1.2 mEq/L, bicarbonate 30 mEq/L, acetate 4.2 mEq/L, and glucose 150 mg/dL.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients undergoing dialysis 3 times a week for 4-6 hours using dialysate K4

Exclusion criteria

Exclusion criteria: Patients with liver dysfunction (serum AST or ALT >= 100 U/L) or cardiac function disorder (>= III of NYHA classification) or respiratory disorder (PO2 < 60 mmHg)

Design outcomes

Primary

Measure	Time frame
Changes in serum potassium, calcium, magnesium, pH, bicarbonate, and glucose levels for one year	—

Secondary

Measure	Time frame
Calcium mass balance during dialysis	—

Countries

Japan

Contacts

Public ContactTadashi Yamamoto

Shirasagi Hospital Research Division

yamamoto@shirasagi-hp.or.jp0667141661

Outcome results

None listed

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