Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2026-02-27 @ 4:33 PM
Study NCT ID:
NCT02230202
Status:
COMPLETED
Last Update Posted:
2018-02-28
First Post:
2014-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endothelial Microparticles: A Novel Marker of Vascular Dysfunction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'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': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'plasma and urine biospecimens to be retained.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-26', 'studyFirstSubmitDate': '2014-08-25', 'studyFirstSubmitQcDate': '2014-08-29', 'lastUpdatePostDateStruct': {'date': '2018-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-09-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Vascular Function', 'timeFrame': 'percent change from baseline over 2 minutes', 'description': 'This will be measured with flow-mediated dilation and evaluate percent change from baseline over minutes.'}], 'secondaryOutcomes': [{'measure': 'Characterization of Microparticle source from blood analysis', 'timeFrame': 'Single time point', 'description': 'A single blood draw to distinguish micro particle source characterization based upon protein, lipid and cholesterol composition.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Kidney Disease']}, 'referencesModule': {'references': [{'pmid': '30006493', 'type': 'DERIVED', 'citation': 'Jalal D, Renner B, Laskowski J, Stites E, Cooper J, Valente K, You Z, Perrenoud L, Le Quintrec M, Muhamed I, Christians U, Klawitter J, Lindorfer MA, Taylor RP, Holers VM, Thurman JM. Endothelial Microparticles and Systemic Complement Activation in Patients With Chronic Kidney Disease. J Am Heart Assoc. 2018 Jul 13;7(14):e007818. doi: 10.1161/JAHA.117.007818.'}]}, 'descriptionModule': {'briefSummary': 'The primary hypothesis of this proposal is that chronic kidney disease (CKD) and treatment with calcineurin inhibitors (CNIs) are each associated with the release of endothelial microparticles into the plasma.', 'detailedDescription': 'The primary hypothesis of this proposal is that chronic kidney disease (CKD) and treatment with calcineurin inhibitors (CNIs) are each associated with the release of endothelial microparticles into the plasma. These injury-associated microparticles have a different molecular/protein composition than those released from endothelial cells in healthy patients, and their abundance correlates with vascular injury. To test this hypothesis the investigators propose a 3 arm case-controlled study including normal controls, individuals with stage III and IV CKD not receiving CNI therapy, and individuals with stage III and IV CKD post kidney transplantation receiving a CNI. The goal of this study is to measure the amount of microparticles in patients with kidney disease who have had a kidney transplant. Another goal of this study is to see if the measurements of microparticles are related to poor function of the vessels (endothelial dysfunction).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '90 volunteers from the Anschutz Medical Campus', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFor Healthy controls:\n\n* BMI less than 40 kg/m\\^2\n* Able to give informed consent\n\nFor Stage III or IV CKD patients:\n\n* BMI less than 40 kg/m\\^2\n* Able to give informed consent\n* An estimated Glomerular-Filtration Rate (GFR) of 20-60 mL/min/1.73m\\^2\n\nFor Post-kidney transplant and stage III or IV CKD patients:\n\n* BMI less than 40 kg/m\\^2\n* Able to give informed consent\n* An estimated Glomerular-Filtration Rate (GFR) of 20-60 mL/min/1.73m\\^2\n\nExclusion Criteria:\n\nFor Healthy controls:\n\n-Women pregnant or breastfeeding\n\nFor Stage III or IV CKD patients:\n\n* Women pregnant or breastfeeding\n* Adults with a life expectancy of less than one year\n* A history of significant liver disease or congestive heart failure\n* Hospitalization within the last three months\n* Active infection on antibiotic therapy\n* Uncontrolled hypertension (\\>140/90)\n* Immunosuppressive therapy within the last year\n\nFor Post-transplant stage III or IV CKD patients:\n\n* Women pregnant or breastfeeding\n* Adults with a life expectancy of less than one year\n* A history of significant liver disease or congestive heart failure\n* Hospitalization within the last three months\n* Active infection on antibiotic therapy\n* Uncontrolled hypertension (\\>140/90)'}, 'identificationModule': {'nctId': 'NCT02230202', 'briefTitle': 'Endothelial Microparticles: A Novel Marker of Vascular Dysfunction', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Endothelial Microparticles: A Novel Marker of Vascular Dysfunction', 'orgStudyIdInfo': {'id': '14-1209'}, 'secondaryIdInfos': [{'id': 'UL1TR001082', 'link': 'https://reporter.nih.gov/quickSearch/UL1TR001082', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy control', 'description': 'Healthy control that meets inclusion/exclusion criteria. Single blood draw and flow-mediated dilation (FMD).', 'interventionNames': ['Other: Flow-mediated dilation', 'Other: single blood draw']}, {'label': 'Stage III or IV CKD patients', 'description': 'Stage III or IV CKD patients that meets inclusion/exclusion criteria. Single blood draw and flow-mediated dilation (FMD).', 'interventionNames': ['Other: Flow-mediated dilation', 'Other: single blood draw']}, {'label': 'Post-transplant patients', 'description': 'Stage III or IV CKD Post-transplant patients that meets inclusion/exclusion criteria. Single blood draw and flow-mediated dilation (FMD).', 'interventionNames': ['Other: Flow-mediated dilation', 'Other: single blood draw']}], 'interventions': [{'name': 'Flow-mediated dilation', 'type': 'OTHER', 'description': 'Flow-mediated dilation used to measure vascular function. The test is minimally invasive, with only a slight discomfort due to the inflation of the arm cuff.', 'armGroupLabels': ['Healthy control', 'Post-transplant patients', 'Stage III or IV CKD patients']}, {'name': 'single blood draw', 'type': 'OTHER', 'description': 'single blood draw of approximately 45 mL.', 'armGroupLabels': ['Healthy control', 'Post-transplant patients', 'Stage III or IV CKD patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Anschutz Medical Campus; CTRC', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado School of Medicine', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}], 'overallOfficials': [{'name': 'Joshua M Thurman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}