Amino acids during dialysis to test effects on stiff blood vessels in kidney failure
Tests amino acids given during dialysis in adults with kidney failure and stiff blood vessels.
Plain-language title generated from the registry record
Registry title: The Intravenous Amino Acid Therapy for Vascular Rigidity in End Stage Renal Disease
Key facts
- Where
- Bergen, NorwaySee the site
Where in Norway
- Haukeland Central HospitalBergen, NorwayNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Haukeland University Hospital
- Trial code
- NCT07392697
- Record updated
- 6 February 2026
- Original description
The goal of this study is to learn if giving amino acids through the dialysis machine can help protect the blood vessels and heart in people with kidney failure. Patients on dialysis often have problems with stiff blood vessels, which increases their risk of heart attacks, strokes, and other cardiovascular diseases. A chemical change called carbamylation is thought to make blood vessels age and stiffen faster. Amino acids may block this process and improve blood vessel health.Read full original descriptionShow less
The Intravenous Amino Acid Therapy for Vascular Rigidity in End Stage Renal Disease
The goal of this study is to learn if giving amino acids through the dialysis machine can help protect the blood vessels and heart in people with kidney failure. Patients on dialysis often have problems with stiff blood vessels, which increases their risk of heart attacks, strokes, and other cardiovascular diseases. A chemical change called carbamylation is thought to make blood vessels age and stiffen faster. Amino acids may block this process and improve blood vessel health.
The main questions are:
* Does amino acid treatment reduce the risk of death in dialysis patients? * Does it improve the health of the heart and blood vessels? * What side effects or medical problems happen when patients receive amino acids during dialysis?
In this study:
* Participants will be randomly assigned to receive either amino acids (Synthamin 9®) or a placebo (saline). * The infusion (250 ml) will be given twice a week during dialysis sessions for 12 months. * After 12 months of treatment, patients will be followed for another 6 months.
During the study, patients will:
* Have regular blood tests to measure markers of blood vessel health, inflammation, and protein carbamylation. * Undergo heart and vessel tests, including echocardiography, CT scans, and pulse wave velocity measurements. * Complete quality-of-life questionnaires about symptoms and daily living.
By comparing the amino acid group with the placebo group, researchers will see whether amino acid therapy can make dialysis patients live longer and have healthier hearts and blood vessels.
Inclusion: Age ≥18 years; Diagnosis of end-stage renal disease (ESRD) and undergoing maintenance hemodialysis (HD) or online hemodiafiltration (HDF); On a stable dialysis regimen for a minimum of 90 consecutive days prior to enrollment; Serum albumin level ≥30 g/L; Documented dialysis adequacy: single-pool Kt/V (spKt/V) > 1.2; Able to understand study procedures and provide written informed consent.
Exclusion: Severe hypertension (e.g., SBP >180 mmHg despite antihypertensive therapy); Advanced liver disease classified as Child-Pugh class C; Diagnosis of active malignancy or cancer treatment within the last 5 years; Psychiatric or cognitive impairment that interferes with informed consent or study compliance; Administration of parenteral amino acids or intravenous nutrition within the past 90 days; Current participation in another interventional study or within the past 30 days; Pregnant or breastfeeding women; Life expectancy <12 months due to unrelated comorbidities.