NCT07392697Not yet recruiting
The Intravenous Amino Acid Therapy for Vascular Rigidity in End Stage Renal Disease
Source: ClinicalTrials.gov · Last updated 6 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 22 Sept 2025
- Start date
- 1 Feb 2026
- Primary completion date
- 1 Aug 2028
- Lead sponsor
- Haukeland University Hospital
- Diseases
- Chronic kidney disease
- NCT number
- NCT07392697
What you commit to
- Study type: Interventional
- Planned participants: 120
- From 1 Feb 2026 to the primary completion date, 1 Aug 2028
- 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.
Other illness
- 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.
Other
- 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.
Who the study is looking for
- 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.
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 |
|---|---|---|---|
| Haukeland Central Hospital Coordinator of this site? Confirm its status | Bergen | Norway | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.