NCT07881627Recruiting
Nutritional Status in Patients With Chronic Kidney Disease Receiving 7.2% Amino Acids During Hemodialysis
The Role of 7.2% Amino Acids in Improving Nutritional Status in Patients With Chronic Kidney Disease Undergoing Hemodialysis: A Retrospective Study
Source: ClinicalTrials.gov · Last updated 19 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 90 (estimated)
- First submitted
- 20 Aug 2026
- Start date
- 25 Jul 2026
- Primary completion date
- 31 Oct 2026
- Lead sponsor
- PT Otsuka Indonesia
- Diseases
- Chronic kidney disease
- NCT number
- NCT07881627
What you commit to
- Study type: Observational
- Planned participants: 90
- From 25 Jul 2026 to the primary completion date, 31 Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- History of acute bleeding at the time of admission or requiring blood transfusion.
Lab values
- Patients who receive albumin administration during study period.
Other
- Patients who are hospitalized at the time of data collection or who require hospitalization during the observation period.
- Patients with clinically evident edema or fluid overload.
- Patients for whom the data required to evaluate the primary endpoint are unavailable.
- Patients with duplicate enrollment in the same study protocol.
Who the study is looking for
- 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
- 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).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Bangli Medika Canti Hospital Coordinator of this site? Confirm its status | Bangli | Indonesia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.