Ammonia; Metabolic DisorderNH4 infNCT04585672
Ammonia Metabolism Assessed by Ammonia Infusion
A study testing Ammonia infusion in people with Ammonia; Metabolic Disorder and Liver Failure, Chronic, run by Aarhus University Hospital at 1 site in Denmark.
Trial summary
The present study will develop a method to assess ammonia metabolism by ammonia infusion and investigate ammonia production and clearance in healthy individuals and in patients with liver cirrhosis. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Ammonia; Metabolic Disorder, Liver Failure, Chronic
- What is being tested?
- Ammonia infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 19 Aug 2020to 31 Dec 2022
- 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 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Alcohol < 40g/day
- BMI < 30
- Diseased or medicated
- Child-Pugh A or B cirrhosis
- BMI < 30
Who cannot join
- Child-Pugh score C
- Kidney failure (eGFR < 60 mL/min/1.73m2)
- Overt hepatic encephalopathy or more than one previous 1 episode of overt hepatic encephalopathy
- Acute bacterial infection
- Cancer
- Diabetes
- Ammonia-targeted treatment of hepatic encephalopathy other than lactulose (including Rifaximin and branched-chain amino acids)
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Department of Hepatology & Gastroenterology
Aarhus, 8200
Marie Fagerlund, +45 23715703, mf@clin.au.dk
About this study
The present study will develop a method to assess ammonia metabolism by ammonia infusion and investigate ammonia production and clearance in healthy individuals and in patients with liver cirrhosis.
- Being tested
- Ammonia infusion
- Medical subject headings
- Metabolic Diseases, End Stage Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ammonia infusionOther
Ammonia metabolism investigated in healthy individuals and patients with cirrhosis with and without ammonia lowering agent: glycerolphenylbutyrat (healthy) and Lactulose + Rifaximin (Cirrhosis)
| Study group | Role | What they receive |
|---|---|---|
| Healthy and Cirrhosis | Other | Ammonia infusion with and without ammonia targeting Receives: Other: Ammonia infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of clearance (L/min) and production (micromol/min) of ammonia
A physiological parameter
Measured: 2 years
Secondary outcomes (1)
Change in clearance (L/min) and production (micromol/min) of ammonia when measured while on ammonia modulating agents
Proof of concept
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start19 Aug 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ammonia; Metabolic DisorderStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04585672
- Sponsor's protocol ID
- 1-16-02-297-20
- Acronym
- NH4 inf
- Status last verified
- Aug 2020
- First submitted
- 23 Sep 2020
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ammonia Metabolism Assessed by Ammonia Infusion
- ClinicalTrials.gov ID
- NCT04585672
- Acronym / sponsor ID
- NH4 inf / 1-16-02-297-20
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Study start
- 19 Aug 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 14 Oct 2020 (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.
The present study will develop a method to assess ammonia metabolism by ammonia infusion and investigate ammonia production and clearance in healthy individuals and in patients with liver cirrhosis.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy and Cirrhosis | Other | Other: Ammonia infusionAmmonia infusion with and without ammonia targeting |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Alcohol < 40g/day
- BMI < 30
- Diseased or medicated
- Child-Pugh A or B cirrhosis
- BMI < 30
Key exclusion criteria (7 listed)
- Child-Pugh score C
- Kidney failure (eGFR < 60 mL/min/1.73m2)
- Overt hepatic encephalopathy or more than one previous 1 episode of overt hepatic encephalopathy
- Acute bacterial infection
- Cancer
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 |
|---|---|---|
| Ammonia infusionAmmonia metabolism investigated in healthy individuals and patients with cirrhosis with and without ammonia lowering agent: glycerolphenylbutyrat (healthy) and Lactulose + Rifaximin (Cirrhosis) | Other | Healthy and Cirrhosis |
Primary outcome
Rate of clearance (L/min) and production (micromol/min) of ammonia
Time frame: 2 years
A physiological parameter
1 secondary outcome
Change in clearance (L/min) and production (micromol/min) of ammonia when measured while on ammonia modulating agents
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- Individual participant dataSharing planned: No
Related trials for Ammonia; Metabolic Disorder
RecruitingObservational study
Long-term Follow-up (LTFU) Study of Participants in Any iECURE Protocol Using an Investigational Product (IP)
Ornithine Transcarbamylase Deficiency, Ornithine Transcarbamylase Deficiency Disease
Not yet recruitingObservational study
Impact of AI-Based Breath Ammonia Kidney Function Results on Clinical Pharmacist Medication Recommendations
Diabetes Mellitus, Type 2, Diabetic Nephropathies
Active, not recruitingObservational study
Wearable NH₃ Sensor for Remote Non-invasive Monitoring and Diagnosis of Diabetic Kidney Disease
Diabetic Nephropathies MeSH:D003928, Diabetes Mellitus, Type 2
RecruitingPhase 1/2
Phase 1/2 Study of KRRO-121 in Healthy Volunteers and Patients With UCD
Urea Cycle Disorders, Inborn, Urea Cycle Disorders
Active, not recruitingPhase 3
An Open-label Study to Investigate ECUR-506 in Male Babies Less Than 9 Months of Age With Neonatal Onset OTC Deficiency
Ornithine Transcarbamylase Deficiency, Ornithine Transcarbamylase Deficiency Disease
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ammonia infusion in people with Ammonia; Metabolic Disorder and Liver Failure, Chronic, run by Aarhus University Hospital 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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 14 Oct 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peter Lykke Eriksen, MD PhD (+45 23715703, ple@clin.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of clearance (L/min) and production (micromol/min) of ammonia (time frame: 2 years). 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 14 Oct 2020.