Analyzing urea production in healthy individuals and patients with urea cycle disorders
Official title: Ureagenesis Analysis in Healthy Subjects and in Urea Cycle Disorder Patients
Run by University Children's Hospital, Zurich · NCT05671666 · Data updated 2026-11-12
This study is testing how well the body makes urea in healthy people and those with urea cycle disorders to better understand these conditions and improve treatments.
Quick facts
| Study type | Interventional |
|---|---|
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | University Children's Hospital, Zurich Academic / other |
| Locations | 1 site (Zurich, Canton of Zurich) |
| Status | Recruiting |
| Started | October 31, 2019 |
| Main results expected | December 31, 2035 |
| Study ends | December 31, 2035 |
| Registry record updated | January 8, 2026 |
| Trial ID | NCT05671666 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include healthy individuals of any age and patients with a confirmed diagnosis of urea cycle disorders.
✕Probably not a fit
Patients with acute or chronic diseases requiring treatment, as well as pregnant or lactating women, may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study focuses on measuring ureagenesis, the production of urea, in both healthy subjects and patients diagnosed with urea cycle disorders (UCDs). By utilizing a stable ammonium chloride isotope as a tracer, researchers aim to evaluate the overall function of the urea cycle, which is crucial for assessing the efficacy of current and future therapies for UCDs. The study seeks to provide a more comprehensive understanding of UCDs compared to traditional methods that analyze individual metabolites or enzymes. Participants will include healthy individuals and UCD patients who meet specific inclusion criteria.
Why it matters
Potential benefit: If successful, this study could lead to improved evaluation methods for novel therapies targeting urea cycle disorders.
How similar studies have gone: While the approach of measuring ureagenesis is innovative, similar studies have not been widely reported, indicating this may be a novel approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * healthy subjects at any age and given written informed consent * subjects with a UCD confirmed by genetic or enzymatic diagnostics at any age and given written informed consent Exclusion Criteria: * healthy subjects with acute and chronic disease requiring treatment of any kind * pregnant or lactating women. * UCD patients with acute and chronic (other than her/his UCD) disease requiring treatment * UCD patients in which intake of carglumic acid cannot be stopped for 24 hours prior to the test
Where it's running
-
University Children's Hospital
Zurich, Canton of Zurich, Switzerland Recruiting
Study contacts
- Study coordinator: Johannes Häberle
- Email: Johannes.haeberle@kispi.uzh.ch
- Phone: 0041-442495988
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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KRRO-121 for hyperammonemia in urea cycle disorders: a first-in-human study
This study tests KRRO-121, a treatment designed to help clear ammonia, in adults with urea cycle disorders and in healthy volunteers to see if it is safe and how it acts in the body.
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LNP.UCD.ABE for severe urea cycle disorders in young children
This trial tests a single IV dose of LNP.UCD.ABE in five young children with severe urea cycle disorders to see if it is safe and may help reduce ammonia buildup.
-
Home Ammonia Monitoring for People with Metabolic Ammonia Disorders
This study tests whether people with certain ammonia metabolism disorders can successfully measure their ammonia levels at home every day.
-
Glycerol phenylbutyrate for Chinese children and teens with urea cycle disorders
This project will try glycerol phenylbutyrate in children and teens in China who have urea cycle disorders to see if it lowers ammonia and reduces hyperammonemic crises over five years.
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Long-term follow-up for participants in an iECURE protocol
This study looks at the long-term safety and effectiveness of a treatment for people who have already been part of an earlier study, while also tracking the health of those who didn’t receive the treatment.
-
Brain mapping of UCD patients during simulated driving
This study tests how brains function in people with urea cycle disorders while they do driving tasks in a simulator, compared with healthy controls.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.