Urea Cycle DisorderNCT05076318
Dysregulated Urea-synthesis at Terminal Uremia
A study testing Aminoacid, alanine-infusion in people with Urea Cycle Disorder and Uremia, run by University of Aarhus at 1 site in Denmark.
Trial 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" Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Urea Cycle Disorder, Uremia
- What is being tested?
- Aminoacid, alanine-infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Mar 2022to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age > or equal to 18 years
- Chronic hemodialysis during 3 months
- Patients with functioning arteriovenous-fistula assigned to "Center-Hemodialysis" at "Nyresygdomme, AUH Skejby"
Who cannot join
- 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
Show all 11Show fewer
- Prednisolone treatment during the last 8 weeks
- Pregnancy
- BMI > 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
Trial locations and contacts
1 site in 1 country.
About this study
This project will examine the dysregulation of the urea cycle in patients with terminal uremia using a validated method named "Functional Hepatic Nitrogen Clearance"
- Conditions
- Urea Cycle Disorder, Uremia
- Being tested
- Aminoacid, alanine-infusion
- Medical subject headings
- Urea Cycle Disorders, Inborn, Uremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aminoacid, alanine-infusionOther
During 3 hours, patient will receive alanine-infusion, while amino-acid and urea will be monitored by blood samples.
| Study group | Role | What they receive |
|---|---|---|
| Alanine-infusion | Experimental | Alanine infusion taking place over a 3 hour period while monitorering metabolic changes in blood samples before and after dialysis Receives: Other: Aminoacid, alanine-infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 hours. 1 hour of blood sample measuring of baseline urea-synthesis rate and 3 hours of urea-synthesis rate during alanine-infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2021
- Study start1 Mar 2022
- Primary completion1 Dec 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urea Cycle DisorderStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05076318
- Sponsor's protocol ID
- Dysregulated urea-synthesis
- Status last verified
- Jan 2022
- First submitted
- 26 Aug 2021
- Last updated
- 4 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dysregulated Urea-synthesis at Terminal Uremia
- ClinicalTrials.gov ID
- NCT05076318
- Acronym / sponsor ID
- Dysregulated urea-synthesis
- Conditions
- Urea Cycle Disorder, Uremia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 13 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project will examine the dysregulation of the urea cycle in patients with terminal uremia using a validated method named "Functional Hepatic Nitrogen Clearance"
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alanine-infusion | Experimental | Other: Aminoacid, alanine-infusionAlanine infusion taking place over a 3 hour period while monitorering metabolic changes in blood samples before and after dialysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > or equal to 18 years
- Chronic hemodialysis during 3 months
- Patients with functioning arteriovenous-fistula assigned to "Center-Hemodialysis" at "Nyresygdomme, AUH Skejby"
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aminoacid, alanine-infusionDuring 3 hours, patient will receive alanine-infusion, while amino-acid and urea will be monitored by blood samples. | Other | Alanine-infusion |
Primary outcome
Urea synthesis rate during alanine 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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aminoacid, alanine-infusion in people with Urea Cycle Disorder and Uremia, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urea synthesis rate during alanine 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.