Clinical trial of OPF-109 in patients with chronic renal failure

JRCT ID: jRCT2051190070

Registered date:31/10/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Chronic Renal Failure
• Date of first enrollment: 25/11/2019
• Target sample size: 130
• Study type: Interventional

Intervention(s)

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 continuously at an administration rate of not less than 25 kcal/kg standard body weight/day and not exceeding 35 kcal/kg standard body weight/day.
When TPN is introduced with the investigational drug, care should be taken about glucose tolerance, abnormal hepatic function, etc., and administration should be started with about half of the maintenance dose. On the second day of administration of the investigational drug, the dose should be gradually increased and from the third day of administration of the investigational drug onward, the maintenance dose should be administered. The dosage should be adjusted according to symptoms, age, and body weight.
(study drug : OPF-109, control drug : HICALIQ RF, KIDMIN injection, Otsuka MV injection)

Outcome(s)

Primary Outcome

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 Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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 <60 mL / min / 1.73 m2
2) Not on dialysis but having chronic kidney failure with Hyperphosphatemia or its potential and eGFR <60 mL / min / 1.73 m2
3) Maintaining regular hemodialysis (HD or HDF)
2. Patients who need TPN for more than 1 week
3. Patients who are Age >= 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

Exclude 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

Related Information

• Primary Sponsor: Kawakami Tatsukuni