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Phase III clinical evaluation of WBCRRD and SPB-KT in patients receiving continuous blood purification therapy (CBP)

Phase III clinical evaluation of WBCRRD and SPB-KT in patients receiving continuous blood purification therapy (CBP)

Kinoshita Kaori

NIPRO CORPORATION

3023, Nojicho, Kusatsu, Shiga

kinoshita-kaori@nipro.co.jp

Kinoshita Kaori

NIPRO CORPORATION

3023, Nojicho, Kusatsu, Shiga

+81-77-564-9467

kinoshita-kaori@nipro.co.jp

Complete

Sept. 27, 2023

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

- Written informed consent from patients or legal representative if patients lack of ability to consent.
- Over 20 years of age at the time of acquiring consent.
- Indications: Fluid overload, Metabolic acidosis, Urine output, Electrolytes disturbance, Intoxication, Cytokine abnormal, Severe pancreatitis acute, Hepatitis fulminant or Postoperative hepatic failure.
, etc.

- Patients who find it difficult to receive treatment under the conditions specified in the study protocol.
- Patients who are pregnant at the time of consent for this study.
- Patients participating in other clinical studies at the time of consent for this study.
- Patients judged to be inadequate for this study by the investigators .
, etc.

Patients who need continuous blood purification therapy

Research subjects receive continuous blood purification therapy using investigational drug WBCRRD or SPB-KT, according to random assignment. During the investigational treatment, the examinations and observations specified in the protocol are conducted.

Both of serum potassium level and serum sodium level are corrected or maintained within the target control range.

+81-3-5800-8743

No

none