ClinicalTrials.gg
CompletedNCT05076318Updated May 4, 2026

Dysregulated Urea-synthesis at Terminal Uremia

An interventional study of Aminoacid, alanine-infusion in Urea Cycle Disorder and Uremia, sponsored by University of Aarhus. Completed at 1 site in Denmark. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-04.

Sponsored by University of Aarhus · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This project will examine the dysregulation of the urea cycle in patients with terminal uremia using a validated method named "Functional Hepatic Nitrogen Clearance"

02

Conditions studied

  • Urea Cycle Disorder
  • Uremia
03

In context

Urea Cycle Disorders, Inborn

66 studies on the registry are indexed under Urea Cycle Disorders, Inborn; 14 are open to participants now.

This study's enrollment of 10 is below the median of 17 across 39 interventional studies indexed under Urea Cycle Disorders, Inborn.

Browse Urea Cycle Disorders, Inborn studies →

Lead sponsor

University of Aarhus is the lead sponsor of 1,300 studies on the registry; 189 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age > or equal to 18 years
  • Chronic hemodialysis during 3 months
  • Patients with functioning arteriovenous-fistula assigned to "Center-Hemodialysis" at "Nyresygdomme, AUH Skejby"

Exclusion criteria

Exclusion Criteria:

  • Active infection
  • Conditions with vomiting or diarrhea
  • Diabetes
  • Active disease being treated with chemotherapy, radiationtherapy, biologic- or similar treatments. Disease under observation can be included.
  • Liver disease
  • Vessels on the upper extremities not suited for cannulation
  • Prednisolone treatment during the last 8 weeks
  • Pregnancy
  • > or equal to 30 or \< or equal to 18
  • Physically or mentally condition that does not allow the project to be completed
  • Language-difficulties that does not allow the project to be completed
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    Alanine-infusion

    Alanine infusion taking place over a 3 hour period while monitorering metabolic changes in blood samples before and after dialysis

    Other: Aminoacid, alanine-infusion

Interventions

  • OtherAminoacid, alanine-infusion

    During 3 hours, patient will receive alanine-infusion, while amino-acid and urea will be monitored by blood samples.

06

What researchers measure

Primary outcomes

  1. Urea synthesis rate during alanine infusion

    Change in the synthesis of urea during a 3 hour period of alanine-infusion in pre and post hemodialysis patients. We will use a validated method named functional hepatic nitrogen clearance (FHNC) to evaluate the synthesis of urea. FHNC is calculated using the linear relation between urea nitrogen synthesis rate and blood-amino acid which is measured every hour. An estimated group of 10 dialysis patients will be included and compared to a clinical healthy group. The healthy group has also received alanine infusion and blood samples of urea and amino-acids has likewise been measured for every hour of infusion.

    Time frame: 4 hours. 1 hour of blood sample measuring of baseline urea-synthesis rate and 3 hours of urea-synthesis rate during alanine-infusion

07

Study locations

1 site
  • University Hospital Aarhus
    Aarhus N, 8200, Denmark
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2022 to primary completion in Dec 2024, 33 months.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 26, 2021
First posted
Oct 13, 2021
StartActual
Mar 1, 2022
Primary completionActual
Dec 1, 2024
CompletionActual
Dec 1, 2024
Last update
May 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05076318
Responsible party
Sponsor
First posted
Oct 13, 2021
Start date
Mar 1, 2022
Primary completion
Dec 1, 2024
Completion
Dec 1, 2024
Last update
May 4, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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