The Intravenous Amino Acid Therapy for Vascular Rigidity in End Stage Renal Disease

NCT07392697 | Not Yet Recruiting

• 1 other identifier: NASCAR HV
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Kidney Disease Requiring Chronic Dialysis; Cardiovascular Calcification

Keywords

carbamylation; chronic kidney disease

Outcome Measures

Primary Outcomes (1)

• All-cause mortality over a 12-month period.

  This outcome is selected due to the low sample size in each group and the expectation that there may not be many hard cardiovascular events within the 1-year follow-up. The use of all-cause mortality provides a robust endpoint that captures overall patient survival. data will be analyzed with Cox proportional hazard regression, Kaplan -Mayer survival curves and log rank test.

  12 month from enrollment

Secondary Outcomes (8)

• CVD

  12 months from enrollment

• CVD 2 - PWV

  12 months from enrollment

• CVD - Alx

  12 months from enrollment

• CVD 3 - CAC

  12 months from enrollment

• CVD 4 - SIS

  12 months from enrollment

Study Arms (2)

Amino Acid Supplementation

EXPERIMENTAL

* Product: Synthamin 9® (Baxter), a sterile, pyrogen-free solution of amino acids for injection (5.5%). * Dose: 250 ml per administration, providing approximately 13.7 g of free amino acids. * Administration: Intravenously during the first hour of hemodialysis. * Frequency: Twice weekly (preferably on the two longest HD sessions) for 12 months.

Dietary Supplement: Amino Acid Supplementation

Placebo

PLACEBO COMPARATOR

* A sterile, pyrogen-free saline solution * Administration: Intravenously during the first hour of hemodialysis. * Frequency: Twice weekly (preferably on the two longest HD sessions) for 12 months.

Other: Sterile Saline Arm

Interventions

Amino Acid Supplementation DIETARY_SUPPLEMENT

* Product: Synthamin 9® (Baxter), a sterile, pyrogen-free solution of amino acids for injection (5.5%). * Dose: 250 ml per administration, providing approximately 13.7 g of free amino acids. * Administration: Intravenously during the first hour of hemodialysis. * Frequency: Twice weekly (preferably on the two longest HD sessions) for 12 months.

Amino Acid Supplementation

Sterile Saline Arm OTHER

Product: Isotonic saline solution (0.9% NaCl), 250 ml. • Administration and frequency: Identical to the intervention arm.

Placebo

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Haukeland University Hospital: lead

Study Sites (1)

Haukeland Central Hospital

Bergen, Norway

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Piotr M Mydel, Md Phd

CONTACT

0047 466 10 782; piotr.mateusz.mydel@helse-bergen.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Neither participant nor investigator and outcomes assesor will be aware if patient recived amino acid solution or saline solution. That knowledge will be only available to care provided and coded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, Double-Blind, Placebo-Controlled Trial

Study Record Dates

• First Submitted: September 22, 2025
• First Posted: February 6, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: February 6, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)