Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2025-12-26 @ 10:49 AM
Study NCT ID:
NCT05266092
Status:
RECRUITING
Last Update Posted:
2022-11-15
First Post:
2022-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Activation of the Contact System and the Immune System in Patients With Chronic Kidney Disease.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], 'ancestors': [{'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'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': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood samples for collecting citrated and EDTA plasma'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-04-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2032-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-14', 'studyFirstSubmitDate': '2022-02-23', 'studyFirstSubmitQcDate': '2022-02-23', 'lastUpdatePostDateStruct': {'date': '2022-11-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma level of cHK', 'timeFrame': 'At enrollment', 'description': 'cHK is the final activation product of the contact activation system'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Contact system', 'Infection', 'Innate immune system', 'Coagulation', 'Chronic kidney disease', 'Hemodialysis', 'End-stage renal disease'], 'conditions': ['Chronic Kidney Disease Requiring Chronic Dialysis']}, 'descriptionModule': {'briefSummary': "Patients with end-stage renal disease undergoing hemodialysis (HD) are burdened with extremely high mortality rates (15% per year) and during the early stage (≤120days) the mortality rate is even higher (27% per year). Cardiovascular complications and bloodstream infections (BSIs) account for the vast majority of deaths in HD patients. In Denmark, BSIs occur in 14% of HD patients per year and is most frequently caused by Staphylococcus aureus (44%). The most frequent infectious complication is endocarditis that has fatal outcomes in ≈50% of the cases. Overall, 10% of HD patients die within 30 days after a positive blood culture for S. aureus. This project aims to answer key questions regarding HD patients' decreased ability to fight S. aureus BSIs and in particular the potential exacerbating effect of HD. We hypothesize that HD patients' blood is significantly compromised by the process of HD, to an extend that lowers immunoactivity against S. aureus. Moreover, we hypothesize, that contact activation promotes the coagulability of blood thus promoting biofilm formation by S. aureus which increases the overall risk of BSI. We will test these hypotheses by collecting blood and analyzing the inflammation and coagulation status in plasma samples from participants before and after HD. We will compare the level of the inflammatory markers in plasma from participants undergoing HD (n=180) to the level in plasma samples from three control groups: healthy volunteers (n=120), participants with renal disease not in dialysis (n=60) and participants undergoing peritoneal dialysis (n=40)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Blood samples and clinical information is collected from 180 participants with chronic kidney disease undergoing hemodialysis, before and after dialysis. Their levels of components from the innate immune system in plasma are compared to the levels in plasma samples from three control groups: 60 participants with chronic kidney disease not in dialysis, 60 participants with chronic kidney disease undergoing peritoneal dialysis and 120 healthy volunteers.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Participants with chronic kidney disease undergoing hemodialysis Inclusion criteria\n\n* Age \\>18 years\n* Chronic kidney disease\n* Hemodialysis\n\nExclusion criteria:\n\n\\- Acute kidney disease\n\nParticipants with chronic kidney disease, not in dialysis Inclusion criteria\n\n* Age \\>18 years\n* Chronic kidney disease (eGFR from \\<15 to 44)\n\nExclusion criteria:\n\n* Acute kidney disease\n* Hemodialysis\n* Peritoneal dialysis\n\nParticipants with chronic kidney disease undergoing peritoneal dialysis Inclusion criteria\n\n* Age \\>18 years\n* Chronic kidney disease\n* Peritoneal dialysis\n\nExclusion criteria:\n\n\\- Acute kidney disease\n\nHealthy volunteers Inclusion criteria\n\n* Age \\>18 years\n* Blooddonors\n\nExclusion criteria:\n\n\\- NA'}, 'identificationModule': {'nctId': 'NCT05266092', 'acronym': 'AKIM-CKD', 'briefTitle': 'Activation of the Contact System and the Immune System in Patients With Chronic Kidney Disease.', 'organization': {'class': 'OTHER', 'fullName': 'Odense University Hospital'}, 'officialTitle': 'Activation of the Contact System and the Immune System in Patients With Chronic Kidney', 'orgStudyIdInfo': {'id': 'OP_1579'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Participants with chronic kidney disease undergoing hemodialysis', 'interventionNames': ['Other: Observational study']}, {'label': 'Participants with chronic kidney disease, not in dialysis', 'interventionNames': ['Other: Observational study']}, {'label': 'Participants with chronic kidney disease undergoing peritoneal dialysis', 'interventionNames': ['Other: Observational study']}, {'label': 'Healthy participants', 'interventionNames': ['Other: Observational study']}], 'interventions': [{'name': 'Observational study', 'type': 'OTHER', 'description': 'Observational study', 'armGroupLabels': ['Healthy participants', 'Participants with chronic kidney disease undergoing hemodialysis', 'Participants with chronic kidney disease undergoing peritoneal dialysis', 'Participants with chronic kidney disease, not in dialysis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5230', 'city': 'Odense', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Katrine Pilely', 'role': 'CONTACT'}], 'facility': 'Odense University Hospital', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}], 'centralContacts': [{'name': 'Katrine Pilely, PhD', 'role': 'CONTACT', 'email': 'kapi@sdu.dk', 'phone': '0045 20963328'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Odense University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Southern Denmark', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Postdoc', 'investigatorFullName': 'Katrine Pilely', 'investigatorAffiliation': 'Odense University Hospital'}}}}