Clinical trials: Ammonia Metabolism
Ornithine Transcarbamylase Deficiency
A Study to Assess Plasma Ammonia Time-Normalized Area Under the Curve and Rate of Ureagenesis in Healthy Adult Subjects
The objective of the study is to characterize 24-hour plasma ammonia levels, characterize urea production rates in healthy normal subjects.
- Trial name
- NCT04269122
- Testing
- No Intervention
- Where
- United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Ultragenyx Pharmaceutical Inc
Urea Cycle Disorder
Observational Study That Will Collect Information on Patients With Urea Cycle Disorders (UCDs)
THRIVE is an observational study that will collect information on patients with UCDs. THRIVE will follow enrolled participants for up to 10 years.
- Trial name
- THRIVE (NCT01948427)
- Where
- United States
- Volunteers
- 203 people
- Sponsor
- Amgen
Urea Cycle Disorder
Study of Glycerol Phenylbutyrate & Sodium Phenylbutyrate in Phenylbutyrate Naïve Patients With Urea Cycle Disorders (UCDs)
This is a randomized, controlled, open-label parallel arm study to assess the safety, tolerability, pharmacokinetics and ammonia control, of RAVICTI® as compared to Sodium phenylbutyrate (NaPBA) in urea cycle disorder subjects…
- Trial name
- NCT03335488
- Testing
- RAVICTI, NaPBA
- Where
- 11 sites in United States, Italy and 2 more
- Volunteers
- 16 people
- Sponsor
- Amgen
Acute Liver Failure, Acute on Chronic Liver Failure (ACLF)
Continuous Renal Replacement Therapy Intensity in Hyperammonemia
Acute liver failure (ALF) and acute-on-chronic liver failure (ACLF) are life-threatening conditions often associated with hyperammonemia, hepatic encephalopathy, and multi-organ dysfunction.
- Conditions
- Acute Liver Failure, Acute on Chronic Liver Failure (ACLF), Acute Kidney Injury, Ammonia Metabolism
- Trial name
- CRITICAL (NCT06987604)
- Testing
- High-dose continuous renal replacement therapy, Conventional-dose continuous renal replacement therapy
- Where
- Brazil
- Volunteers
- 152 people
- Sponsor
- Hospital de Clinicas de Porto Alegre
Hepatic Encephalopathy, Acute on Chronic Liver Failure (ACLF)
A Study to See if an Investigational Medicine Called VS-01 Can Help and How Safe it is in the Treatment of Patients With Overt Hepatic Encephalopathy
A Phase 2, Randomized, Controlled, Open-Label, Adaptive Dose Design, Proof-of-Concept Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Two Different Dwell Times of VS-01 on Top of Standard of Care versus Standard…
- Conditions
- Hepatic Encephalopathy, Acute on Chronic Liver Failure (ACLF), Decompensated Cirrhosis
- Trial name
- NCT06987968
- Testing
- VS-01 on top of SOC (Active Treatment Group), SOC
- Where
- 6 sites in United States, France and 1 more
- Volunteers
- 3 people
- Sponsor
- Genfit
Diabetes Mellitus, Type 2, Diabetic Nephropathies
Impact of AI-Based Breath Ammonia Kidney Function Results on Clinical Pharmacist Medication Recommendations
This retrospective study evaluates whether providing clinicians with artificial intelligence (AI)-based kidney function results from a breath ammonia test can improve the quality of medication recommendations made by clinical…
- Trial name
- NCT07888855
- Where
- China
- Volunteers
- 380 people
- Sponsor
- Shanghai Pudong Hospital
Liver Cirrhosis, Hepatic Encephalopathy
Cerebral Oxygen, Blood Flow and Ammonia Uptake in Patients With Cirrhosis and an Acute Episode of Hepatic Encephalopathy (HE)
We wish to study patients with liver cirrhosis during and 2 weeks after an acute episode of liver coma (hepatic encephalopathy).
- Trial name
- NCT01151475
- Where
- Denmark
- Volunteers
- 10 people
- Sponsor
- University of Aarhus
Hepatic Encephalopathy
The Effects of Nitazoxanide in Hepatic Encephalopathy
Evaluating the efficacy and safety of nitazoxanide in comparison to standard treatment in patients with grade II-III hepatic encephalopathy (HE).
- Trial name
- NCT02334163
- Testing
- Nitazoxanide, Oral lactulose, Metronidazole
- Where
- Egypt
- Volunteers
- 36 people
- Sponsor
- Ain Shams University
Brain Diseases, Metabolic, Inborn, Urea Cycle Disorder
Neurologic Injuries in Adults With Urea Cycle Disorders
Urea cycle disorders (UCDs) are a group of rare inherited metabolism disorders. The purpose of this study is to evaluate how UCD-related neurologic injuries affect adults with one of the most common types of UCD.
- Conditions
- Brain Diseases, Metabolic, Inborn, Urea Cycle Disorder, Ornithine Transcarbamylase Deficiency
- Trial name
- NCT00472732
- Where
- 2 sites in United States
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Andrea Gropman
Ammonia Metabolism
L-carnitine Corrects Ammonia Metabolism in Hepatectomized Patients
L-carnitine is synthesized from lysine and methionine. Postmortem concentrations of carnitine in liver, muscle, heart, kidney, and brain averaged only one-fourth to one-third those in corresponding tissues of eight normally…
- Trial name
- NCT03021876
- Testing
- L-carnitine, usual intake
- Where
- Japan
- Volunteers
- 80 people
- Sponsor
- Kochi University
Urea Cycle Disorders, Organic Acidemias
Pilot Study For Hypothermia Treatment In Hyperammonemic Encephalopathy In Neonates And Very Young Infants
This is a pilot study which will test the safety and feasibility of hypothermia treatment as adjunct therapy to conventional treatment of hyperammonemic encephalopathy (HAE) in neonates versus conventional treatment (dialysis…
- Trial name
- NCT01624311
- Testing
- Therapeutic Hypothermia, Standard of Care Therapy
- Where
- 3 sites in United States
- Volunteers
- 5 people
- Sponsor
- Uta Lichter-Konecki
Liver Diseases, Hepatic Encephalopathy
Effects of Branched-Chain Amino Acids on Muscle Ammonia Metabolism in Patients With Cirrhosis and Healthy Subjects
The purpose of this study is to determine whether Branched chain Amino Acids enhances the uptake of ammonia in muscle tissue.
- Conditions
- Liver Diseases, Hepatic Encephalopathy, Hepatic Insufficiency
- Trial name
- NCT00931060
- Testing
- Branched chain amino acids
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- University of Aarhus
Urea Cycle Disorders
Clinical Food Study to Evaluate the Effect of KB195 on Gut Nitrogen Metabolism in Patients With Urea Cycle Disorders
This clinical food study aims to explore the effect of KB195, a novel mixture of oligosaccharides, on the metabolism of nitrogen by the microbiome in patients with urea cycle disorders (UCDs).
- Trial name
- NCT03797131
- Testing
- KB195 (a novel mixture of oligosaccharides)
- Where
- Switzerland
- Volunteers
- 4 people
- Sponsor
- Kaleido Biosciences
Malnutrition
Breath Analysis & Malnutrition
The purpose of this research study is to understand how breath is related to nutritional status. The procedures involved in this study include blood and breath sampling, questionnaires about health history, medications…
- Trial name
- BAM-S (NCT06115148)
- Testing
- Feeding, Fasting
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Pennington Biomedical Research Center
Hepatic Encephalopathy
MNK-6105 for Patients With Cirrhosis and High Ammonia Levels Affecting Brain Function
This study is for patients with cirrhosis and hepatic encephalopathy who are in the hospital. This means they have a high ammonia level which is affecting their brain function.
- Trial name
- NCT04128462
- Testing
- MNK-6105, Standard of Care
- Sponsor
- Mallinckrodt
Liver Cirrhosis
Probiotics for the Prevention of Major Complications of Cirrhosis
The purpose of this study is to determine whether probiotics are effective in the prevention of the complications of liver cirrhosis.
- Trial name
- NCT00312910
- Testing
- Probiotics-Bio-plus
- Where
- Israel
- Volunteers
- 50 people
- Sponsor
- Meir Medical Center
Ammonia; Metabolic Disorder, Liver Failure, Chronic
Ammonia Metabolism Assessed by Ammonia Infusion
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.
- Trial name
- NH4 inf (NCT04585672)
- Testing
- Ammonia infusion
- Where
- Denmark
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Aarhus University Hospital
Urea Cycle Disorders, Organic Acidemias
At Home Ammonia Monitoring of Inborn Errors of Ammonia Metabolism
The goal of this observational study is to learn if people with certain ammonia metabolism disorders will measure their ammonia levels at home.
- Conditions
- Urea Cycle Disorders, Organic Acidemias, Fatty Acid Oxidation Disorder, Ammonia; Metabolic Disorder
- Trial name
- NCT06953505
- Testing
- Ammonia Study Device
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Sequitur Health Corp.
Diabetic Nephropathies MeSH:D003928, Diabetes Mellitus, Type 2
Wearable NH₃ Sensor for Remote Non-invasive Monitoring and Diagnosis of Diabetic Kidney Disease
This observational study aims to validate whether a novel wearable sensor can non-invasively and remotely assess the renal health status of patients with diabetes by detecting the concentration of ammonia (NH₃) in exhaled breath…
- Conditions
- Diabetic Nephropathies MeSH:D003928, Diabetes Mellitus, Type 2, Kidney Diseases
- Trial name
- NCT07875010
- Where
- China
- Volunteers
- 380 people
- Sponsor
- Shanghai Pudong Hospital
Fulminant Hepatic Failure
Cerebral Microdialysis in Patients With Fulminant Hepatic Failure
Patients with fulminant hepatic failure (FHF) often develop cerebral edema, high intracranial pressure (ICP)that may result in fatal brain damage.
- Trial name
- NCT00836420
- Testing
- no intervention
- Where
- Denmark
- Volunteers
- 50 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet