MalnutitrionNCT07881627
Nutritional Status in Patients With Chronic Kidney Disease Receiving 7.2% Amino Acids During Hemodialysis
An observational study of Malnutitrion and Chronic Kidney Disease on Hemodialysis, run by PT Otsuka Indonesia at 1 site in Indonesia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malnutitrion, Chronic Kidney Disease on Hemodialysis, Anemia (Diagnosis)
- Type of treatment
- Injection or infusion
- How many people
- 90 participants
- Where
- 1 siteIndonesia
- Study dates
- 25 Jul 2026to 30 Dec 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with CKD undergoing maintenance hemodialysis at Bangli Medika Canti Hospital who have malnutrition and anemia
Who may be able to join
- Age ≥ 18 years.
- Outpatients undergoing maintenance hemodialysis at Bangli Medika Canti Hospital who are clinically stable and are not experiencing any acute condition.
- 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:
- Body Mass Index (BMI) less than 18.5 kg/m2
- Mid-upper arm circumference (MUAC) less than 24.5 cm
- Serum pre-albumin level less than 16 mg/dL
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- Confirmed anemia, defined as a hemoglobin (Hb) concentration below the normal reference range within 1-7 days, specifically an Hb level of less than 13.0 g/dL in male patients or less than 12.0 g/dL in female patients.
- At least 3 months of maintenance haemodialysis with duration of 3-4 hours per session, 2-3 times per week.
- Provision of written informed consent prior to enrollment in this study (patient is available, can be contacted and approached).
Who cannot join
- Patients who are hospitalized at the time of data collection or who require hospitalization during the observation period.
- History of acute bleeding at the time of admission or requiring blood transfusion.
- Patients with clinically evident edema or fluid overload.
- Patients receiving other enteral or parenteral nutritional support concomitantly during observation period.
- Patients who had received IDPN before observation period
- Patients who have received IDPN in other dialysis clinic/facilities before transferring to Bangli Medika Canti Hospital will be excluded from the study.
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- Patients for whom the data required to evaluate the primary endpoint are unavailable.
- Patients with duplicate enrollment in the same study protocol.
- Patients who receive albumin administration during study period.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Indonesia1 site, 1 recruiting
- Recruiting
Bangli Medika Canti Hospital
Bangli, Bali, 80661
I Made Rama Putra, MD, PhD, +62217654466, darini@ho.otsuka.co.id
I Made Rama Putra, MD, PhD
About this study
Official title: The Role of 7.2% Amino Acids in Improving Nutritional Status in Patients With Chronic Kidney Disease Undergoing Hemodialysis: A Retrospective Study
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.
Read the detailed description
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.
- Keywords
- amino acids, Intradialytic Parenteral Nutrition, Nutritional Status, hemodialysis
- Medical subject headings
- Anemia, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| IDPN Group | 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. | |
| Control Group | Patients undergoing maintenance hemodialysis who do not receive IDPN. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to month 3
Secondary outcomes (6)
Serum Albumin Level at Follow-up
Serum albumin levels (g/dL) at follow-up, compared between IDPN and control groups.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to end of study (Months 3-6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study start25 Jul 2026
- Primary completion31 Oct 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutitrionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PT Otsuka Indonesia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07881627
- Sponsor's protocol ID
- 2024_PTOI_KD_02
- Status last verified
- Oct 2026
- First submitted
- 20 Aug 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided