Chronic Renal Failure
Conditions
Interventions
The dose of energy of the allocated investigational drug is 30 kcal/kg standard body weight/day as a standard maintenance dose. The investigational drug is infused via a central vein for 24 hours cont
Sponsors
Kawakami Tatsukuni
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who meet at least one of the following inclusion criteria: 1) Not on dialysis but having chronic kidney failure with Hyperkalemia or its potential and eGFR = 20 years at the time the informed consent obtained 4. Patients who can obtain an informed consent from themselves or their regal representatives before any study related procedure
Exclusion criteria
Exclusion criteria: 1. Patients with BMI less than 16 kg/m2 2. Patients who do not have any electrolyte abnormalities as follows: 1) Na:>=155 mEq/L 2) Cl:>=129 mEq/L 3) Ca:>=12.5 mg/dL 4) K:<2.5 mEq/L 5) P:<1.5 mg/dL 3. Patients with hypermagnesemia and hypothyroidism 4. Patients with hyperammonemia 5. Patients with lactic acidemia 6. Patients with hepatic coma or its suspection 7. Patients with inborn errors of amino acid metabolism 8. Patients with hemophilia 9. Patients with a history of hypersensitivity to the formulated ingredients of the investigational drug 10. Patients who are managed by CRRT at the time of registration or scheduled to receive CRRT between the time of registration and the end of observation/examination on the 8th day of investigational drug administration 11. Patients who have undergone chemotherapy/radiotherapy within 4 weeks prior to the date of registration or are scheduled to undergo the chemotherapy/radiotherapy between the date of registration and the end of observation/examination on the 8th day of investigational drug administration 12. Patients who have undergone surgery with general anesthesia within 1 week prior to the registration date or who are scheduled to undergo the surgery with general anesthesia between the date of registration and the end of observation/examination on the 8th day of investigational drug administration 13. Patient with pregnant or breast-feeding 14. Patients who participated in a clinical research involving the use of investigational or unapproved drugs within 16 weeks prior to the registration date 15. Patients judged to be ineligible for this clinical trial by the principal investigator or sub investigators, such as who are at high risk for refeeding syndrome and did not complete the investigation because of severe complications
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PROT of Study treatment day 8 ALB of Study treatment day 8 PREALB of Study treatment day 8 TFERRIN of Study treatment day 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| Values and Transition of PROT Values and Transition of ALB Values and Transition of PREALB Values and Transition of RBP Values and Transition of TFERRIN Values and Transition of VITB1 Values and Transition of VITB6 Values and Transition of VITC Values and Transition of VITB9 Values and Transition of VITK1 | — |
Contacts
Public ContactTatsukuni Kawakami
Otsuka Pharmaceutical Factory, Inc.
Outcome results
None listed