Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2025-12-26 @ 2:13 AM
Study NCT ID:
NCT00696605
Status:
COMPLETED
Last Update Posted:
2017-02-27
First Post:
2008-06-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessment of Circulating Copeptin Levels in Healthy Subjects and Patients With Renal Insufficiency After Oral Water Load and Hypertonic Saline Infusion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D003919', 'term': 'Diabetes Insipidus'}], 'ancestors': [{'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'}, {'id': 'D010900', 'term': 'Pituitary Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-23', 'studyFirstSubmitDate': '2008-06-10', 'studyFirstSubmitQcDate': '2008-06-11', 'lastUpdatePostDateStruct': {'date': '2017-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-06-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hypoosmolality', 'Hyperosmolality', 'Copeptin', 'Vasopressin'], 'conditions': ['Hypoosmolality', 'Hyperosmolality', 'Renal Failure']}, 'referencesModule': {'references': [{'pmid': '21289257', 'type': 'DERIVED', 'citation': 'Balanescu S, Kopp P, Gaskill MB, Morgenthaler NG, Schindler C, Rutishauser J. Correlation of plasma copeptin and vasopressin concentrations in hypo-, iso-, and hyperosmolar States. J Clin Endocrinol Metab. 2011 Apr;96(4):1046-52. doi: 10.1210/jc.2010-2499. Epub 2011 Feb 2.'}]}, 'descriptionModule': {'briefSummary': 'The are 2 principal goals in this study:\n\n1. To measure plasma copeptin levels in healthy subjects and to correlate them with plasma AVP concentrations and urine osmolalities in iso-, hypo-, and hyperosmolar states.\n2. To measure plasma copeptin concentrations in patients with chronic renal failure under the same conditions described above, in order to characterize the impact of renal function on circulating copeptin levels in correlation to plasma AVP and urine osmolality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy volunteers; patients with chronic renal failure', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* chronic renal failure grade I through IV\n* healthy age-matched controls\n\nExclusion Criteria:\n\n* chronic renal failure grade V\n* heart failure\n* liver disease\n* nephrotic syndrome\n* anemia (hemoglobin level \\< 100 g/L)\n* uncontrolled hypertension (systolic BP \\> 160 mmHg; diastolic BP \\> 95 mm Hg)\n* coexisting severe disease\n* known thyroid disease\n* known hypocortisolism\n* known hypercortisolism\n* known diabetes insipidus\n* pregnancy\n* lactation'}, 'identificationModule': {'nctId': 'NCT00696605', 'briefTitle': 'Assessment of Circulating Copeptin Levels in Healthy Subjects and Patients With Renal Insufficiency After Oral Water Load and Hypertonic Saline Infusion', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Centre Biel/Bienne'}, 'officialTitle': 'Assessment of Circulating Copeptin Levels in Healthy Subjects and Patients With Renal Insufficiency After Oral Water Load and Hypertonic Saline Infusion', 'orgStudyIdInfo': {'id': 'Swiss AVP-Copeptin Trial'}}, 'contactsLocationsModule': {'locations': [{'zip': '2501', 'city': 'Biel/Bienne', 'country': 'Switzerland', 'facility': 'Clinic of Internal Medicine, Hospital Center', 'geoPoint': {'lat': 47.13713, 'lon': 7.24608}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Centre Biel/Bienne', 'class': 'OTHER'}, 'collaborators': [{'name': 'Brahms AG', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Jonas Rutishauser', 'investigatorAffiliation': 'Hospital Centre Biel/Bienne'}}}}