The Intravenous Amino Acid Therapy for Vascular Rigidity in End Stage Renal Disease (NCT07392697) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
The Intravenous Amino Acid Therapy for Vascular Rigidity in End Stage Renal Disease
Norway120 participantsStarted 2026-02-01
Plain-language summary
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.
Who can participate
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* Administration of parenteral amino acids or intravenous nutrition within the past 90 days.
* 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.
* Current participation in another interventional study or within the past 30 days.
* Pregnant or breastfeeding women.
* Psychiatric or cognitive impairment that interferes with informed consent or study compliance.
* Life expectancy \<12 months due to unrelated comorbidities.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.