An observational study in Malnutitrion, Chronic Kidney Disease on Hemodialysis and Anemia (Diagnosis), sponsored by PT Otsuka Indonesia. Recruiting at 1 site in Indonesia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by PT Otsuka Indonesia (part of Otsuka Holdings Co., Ltd.) · Observational
Malnutrition and anemia are common among people with chronic kidney disease who receive maintenance hemodialysis. These conditions may worsen health outcomes and quality of life. Intradialytic parenteral nutrition (IDPN) provides nutrients through a vein during hemodialysis and may be used when dietary intake is not sufficient. However, evidence on IDPN containing only amino acids, particularly in adults undergoing hemodialysis in Indonesia, remains limited.
This retrospective observational study will evaluate whether a 7.2% amino acid solution (KIDMIN®) given as IDPN is associated with improved nutritional status in adults with chronic kidney disease receiving maintenance hemodialysis. Medical records from Bangli Medika Canti Hospital covering July 2023 through December 2024 will be reviewed. Patients who received KIDMIN® during hemodialysis for at least 3 months will be compared with patients who did not receive IDPN. Both groups received the standard diet recommended for chronic kidney disease.
The main outcome is the change in serum albumin level from baseline to Month 3. Other outcomes include serum albumin through Month 6, hemoglobin levels, nutritional status assessed using the Subjective Global Assessment, and quality of life assessed using the Kidney Disease Quality of Life questionnaire. No study-specific medication or additional invasive procedure will be administered because the study uses previously available clinical data.
Malnutrition, including protein-energy wasting, is a common complication among patients with chronic kidney disease (CKD) undergoing maintenance hemodialysis. Factors contributing to nutritional impairment include inadequate dietary intake, nutrient losses during dialysis, chronic inflammation, and altered protein metabolism. These conditions may adversely affect clinical outcomes and quality of life.
Intradialytic parenteral nutrition (IDPN) is an adjunctive nutritional approach for patients whose nutritional requirements cannot be adequately met through oral or enteral intake. While conventional IDPN formulations generally contain a combination of amino acids, glucose, and lipids, a 7.2% amino acid solution has been used as an alternative in routine clinical practice at the study site due to formulary availability and resource limitations. Evidence regarding the clinical benefits of amino acid-only IDPN in adult patients undergoing maintenance hemodialysis remains limited, particularly in Indonesia.
This retrospective observational study evaluates real-world clinical data from patients undergoing maintenance hemodialysis at Bangli Medika Canti Hospital, Indonesia. The study compares patients with documented exposure to 7.2% amino acid IDPN (KIDMIN®) and patients who did not receive IDPN during routine clinical care. Data will be obtained from existing medical records without assigning treatments or administering study-specific medicinal products. Comparative statistical analyses will be conducted, with adjustment for baseline differences where appropriate. Patient confidentiality will be protected through de-identification of study data.
1,768 studies on the registry are indexed under Anemia; 244 are open to participants now.
This study's planned enrollment of 90 is below the median of 200 across 331 observational studies indexed under Anemia.
Browse Anemia studies →PT Otsuka Indonesia is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
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Patients with CKD undergoing maintenance hemodialysis at Bangli Medika Canti Hospital who have malnutrition and anemia
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Confirmed malnutrition, defined as a condition resulting from insufficient or imbalanced intake of energy, protein, and/or other nutrients, which may adversely affect body composition, physical and mental function, and clinical outcomes, and meeting all of the following criteria within 1-7 days:
Exclusion Criteria:
Patients undergoing maintenance hemodialysis who receive IDPN during the hemodialysis procedure. IDPN administration is initiated 1-1.5 hours before the end of each dialysis session. The product used is KIDMIN® 200 mL injection, administered for a minimum period of 3 months.
Patients undergoing maintenance hemodialysis who do not receive IDPN.
Change in Serum Albumin Level from Baseline to Month 3
Serum albumin will be measured in grams per deciliter (g/dL). The change will be calculated as the serum albumin level at Month 3 minus the serum albumin level at baseline. The change will be compared between patients who received intradialytic parenteral nutrition (IDPN) and patients who did not receive IDPN.
Time frame: Baseline to month 3
Serum Albumin Level at Follow-up
Serum albumin levels (g/dL) at follow-up, compared between IDPN and control groups.
Time frame: Month 3 and end of study (Months 3-6
Change in Serum Albumin From Baseline
Change in serum albumin (g/dL), calculated as end-of-study minus baseline, compared between groups.
Time frame: Baseline to end of study (Months 3-6)
Hemoglobin Level at Each Assessment
Hemoglobin levels (g/dL) at scheduled assessments, compared between IDPN and control groups.
Time frame: Baseline; Months 1, 2, 3; end of study (Months 3-6)
Change in Hemoglobin From Baseline
Change in hemoglobin (g/dL), calculated as follow-up minus baseline, compared between groups.
Time frame: Baseline to Months 1, 2, 3 and end of study (Months 3-6)
Change in Nutritional Status Assessed by SGA
7-point SGA assessment at baseline and end of study, compared between IDPN and control groups.
Time frame: Baseline to end of study (Months 3-6)
Change in Quality of Life Assessed by KDQOL-36
KDQOL-36 score assessment at baseline and end of study, compared between IDPN and control groups.
Time frame: Baseline to end of study (Months 3-6)
Plan to share: Undecided
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