Chronic kidney disease (CKD)
Conditions
Interventions
None listed
Sponsors
Otsuka Pharmaceutical Factory, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Common to study 1, study 2 and study 3 (1)Patients aged 20 years or older on the date of informed consent. (2)Patients who are able to provide written informed consent or whose legally acceptable representative is able to provide written informed consent. (3)Patients who have not undergone any surgery within 1 week before the day of providing informed consent. Common to study 1 and study 2 (1)Patients who are graded as G3b, G4, or G5 according to the severity classification of CKD or have received stable hemodialysis or hemodiafiltration 3 times a week. Only for study 1 (1)Patients who do not receive TPN at the time of providing informed consent. Only for study 2 (1)Patients who receive TPN at the time of providing informed consent. Only for study 3 (1)Patients who have received stable hemodialysis or hemodiafiltration 3 times a week. (2)Patients who do not receive TPN at the time of providing informed consent and planned to receive TPN with multivitamins for total parenteral nutrition every day at fasting from the day of initiation of TPN to third hemodialysis.
Exclusion criteria
Exclusion criteria: (1)Patients who have taken any supplement containing vitamin A and vitamin C from the day of providing informed consent to enrollment. (2)Patients with severe hepatic impairment. (3)Patients with hepatic coma or with a risk of hepatic coma. (4)Pregnant or lactating women (5)Patients who received blood sampling of more than 200 mL within 4 weeks before the date of informed consent and patients who received blood sampling of more than 400 mL within 16 weeks before the date of informed consent (in all cases, blood domination is included and blood collection for autologous blood transfusion is excluded). (6)Patients who participated in a clinical trial or clinical research where a drug is administered to patients, within 16 weeks before the date of informed consent. (7)Other patients who have been determined as ineligible by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood concentrations of vitamin A | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood concentrations of vitamin C | — |
Countries
Japan
Contacts
Public ContactTatsukuni Kawakami
Otsuka Pharmaceutical Factory, Inc. Clinical Development Department, Research and Development Center
Outcome results
None listed