Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT05076318
Status:
UNKNOWN
Last Update Posted:
2021-10-13
First Post:
2021-08-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dysregulated Urea-synthesis at Terminal Uremia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056806', 'term': 'Urea Cycle Disorders, Inborn'}, {'id': 'D014511', 'term': 'Uremia'}], 'ancestors': [{'id': 'D020739', 'term': 'Brain Diseases, Metabolic, Inborn'}, {'id': 'D001928', 'term': 'Brain Diseases, Metabolic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000592', 'term': 'Amino Acid Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000596', 'term': 'Amino Acids'}], 'ancestors': [{'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 16}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-10-12', 'studyFirstSubmitDate': '2021-08-26', 'studyFirstSubmitQcDate': '2021-10-12', 'lastUpdatePostDateStruct': {'date': '2021-10-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Urea synthesis rate during alanine infusion', 'timeFrame': '4 hours. 1 hour of blood sample measuring of baseline urea-synthesis rate and 3 hours of urea-synthesis rate during alanine-infusion', 'description': '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.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Urea Cycle Disorder', 'Uremia']}, 'descriptionModule': {'briefSummary': 'This project will examine the dysregulation of the urea cycle in patients with terminal uremia using a validated method named "Functional Hepatic Nitrogen Clearance"'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> or equal to 18 years\n* Chronic hemodialysis during 3 months\n* Patients with functioning arteriovenous-fistula assigned to "Center-Hemodialysis" at "Nyresygdomme, AUH Skejby"\n\nExclusion Criteria:\n\n* Active infection\n* Conditions with vomiting or diarrhea\n* Diabetes\n* Active disease being treated with chemotherapy, radiationtherapy, biologic- or similar treatments. Disease under observation can be included.\n* Liver disease\n* Vessels on the upper extremities not suited for cannulation\n* Prednisolone treatment during the last 8 weeks\n* Pregnancy\n* BMI \\> or equal to 30 or \\< or equal to 18\n* Physically or mentally condition that does not allow the project to be completed\n* Language-difficulties that does not allow the project to be completed'}, 'identificationModule': {'nctId': 'NCT05076318', 'briefTitle': 'Dysregulated Urea-synthesis at Terminal Uremia', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Dysregulated Urea-synthesis at Terminal Uremia', 'orgStudyIdInfo': {'id': 'Dysregulated urea-synthesis'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Alanine-infusion', 'description': 'Alanine infusion taking place over a 3 hour period while monitorering metabolic changes in blood samples before and after dialysis', 'interventionNames': ['Other: Aminoacid, alanine-infusion']}], 'interventions': [{'name': 'Aminoacid, alanine-infusion', 'type': 'OTHER', 'description': 'During 3 hours, patient will receive alanine-infusion, while amino-acid and urea will be monitored by blood samples.', 'armGroupLabels': ['Alanine-infusion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8200', 'city': 'Aarhus N', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Rasmus Eriksen, MD', 'role': 'CONTACT', 'email': 'raerik@rm.dk', 'phone': '30264691'}], 'facility': 'University Hospital Aarhus', 'geoPoint': {'lat': 56.20367, 'lon': 10.17317}}], 'centralContacts': [{'name': 'Rasmus Eriksen, MD', 'role': 'CONTACT', 'email': 'rasmus.s.eriksen@hotmail.com', 'phone': '30264691'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}