Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-26 @ 2:33 AM
Study NCT ID:
NCT04984902
Status:
UNKNOWN
Last Update Posted:
2021-12-17
First Post:
2021-04-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Reduction of BK Viremia in Kidney Transplant Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007674', 'term': 'Kidney Diseases'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The primary objective is to demonstrate the reduction of BK viremia by treating kidney transplant patients with the Seraph 100 Microbind® Affinity Blood Filter from ExThera Medical.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2023-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-12-16', 'studyFirstSubmitDate': '2021-04-21', 'studyFirstSubmitQcDate': '2021-07-29', 'lastUpdatePostDateStruct': {'date': '2021-12-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'N (%) of patients with treatment emergent adverse events', 'timeFrame': '2 months', 'description': 'N (%) of patients with treatment emergent adverse events'}, {'measure': 'Laboratory data', 'timeFrame': '2 months', 'description': 'Laboratory data (Blood test, Hematology, chemistry and coagulation)'}, {'measure': 'Vital signs score', 'timeFrame': '2 months', 'description': 'Vital signs score'}, {'measure': 'Physical examination score', 'timeFrame': '2 months', 'description': 'Physical examination score'}], 'primaryOutcomes': [{'measure': 'Change in log 10 viral load', 'timeFrame': 'At day 0 and the following 3 treatments within five days after beginning with the first treatment.', 'description': 'Time-weighted change from baseline in log10 viral load within five days after first treatment.'}], 'secondaryOutcomes': [{'measure': 'Number of participants with leukopenia', 'timeFrame': 'At day 0 and the following 3 treatments within five days after beginning with the first treatment.', 'description': 'Number of participants with leukopenia'}, {'measure': 'Number of participants with increase in serum creatinine', 'timeFrame': 'At day 0 and the following 3 treatments within five days after beginning with the first treatment.', 'description': 'Number of participants with increase in serum creatinine between the treatment days'}, {'measure': 'Number of participants with inoperative hypotension', 'timeFrame': 'At 0 and the following 3 treatments within five days after beginning with the first treatment.', 'description': 'Number of participants with inoperative hypotension per treatment period'}, {'measure': 'Number of participants with decreasing haemoglobin measurements', 'timeFrame': 'At day 0 and the following 3 treatments within five days after beginning with the first treatment.', 'description': 'Number of participants with decreasing haemoglobin measurements per treatment period'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['BK Virus'], 'conditions': ['Kidney Diseases', 'Kidney Transplant Infection', 'Kidney Transplant; Complications']}, 'descriptionModule': {'briefSummary': 'Reduction of BK Viremia by treating kidney transplant patients.', 'detailedDescription': 'a clinical investigation plan (CIP) for the "Reduction of BK viremia in kidney transplant patients using the Seraph 100 Microbind® Affinity (Seraph 100) Blood Filter" clinical study, where BK is an abbreviation of the name of the first patient whom the virus was isolated from in 1971. This clinical study is intended to evaluate the reduction of BK viremia by treating kidney transplant patients with the Seraph 100 Microbind® Affinity Blood Filter from ExThera Medical. This clinical study is sponsored by ExThera Medical Corporation.\n\nThis clinical study will be conducted in accordance with this CIP. All parties involved in the conduct of the clinical study will be qualified by education, training, or experience to perform their tasks and this training will be documented appropriately.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Kidney transplant patients with a BK-viraemia ≥ 10,000 IU/ml.\n2. Be ≥ 18 years old and ≤ 90 years old\n3. Existing hemodialysis access\n\nExclusion Criteria:\n\n1. Subject is currently participating in another clinical investigation\n2. Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period\n3. Presence of comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results\n4. Have Child-Pugh Class C cirrhosis\n5. Have platelet count \\<30.000/uL\n6. Contraindications for heparin sodium for injection\n7. Subjects demonstrating any contraindication for this treatment as described in the IFU\n8. Patients without existing hemodialysis access"}, 'identificationModule': {'nctId': 'NCT04984902', 'acronym': 'CP026', 'briefTitle': 'Reduction of BK Viremia in Kidney Transplant Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'ExThera Medical Europe BV'}, 'officialTitle': 'Reduction of BK Viremia in Kidney Transplant Patients Using the Seraph 100 Microbind® Affinity (Seraph 100) Blood Filter', 'orgStudyIdInfo': {'id': 'CP026'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'Treatment with Microbind® Affinity Blood Filter', 'interventionNames': ['Device: Extracorporal therapy']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Antibiotics'}], 'interventions': [{'name': 'Extracorporal therapy', 'type': 'DEVICE', 'description': 'Extracorporal therapy', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Essen', 'country': 'Germany', 'contacts': [{'name': 'Bartosz Tyczynski, Dr.', 'role': 'CONTACT'}, {'name': 'Kristina Boss, Dr.', 'role': 'CONTACT'}, {'name': 'Bartosz Tyczynski, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Kristina Boss, Dr.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University Hospital Essen', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}], 'centralContacts': [{'name': 'Carla Kikken-Jussen', 'role': 'CONTACT', 'email': 'carla@extheramedical.com', 'phone': '+31 43 8200 399'}], 'overallOfficials': [{'name': 'Bartosz Tyczynski, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Essen'}]}, 'ipdSharingStatementModule': {'infoTypes': ['CSR'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ExThera Medical Europe BV', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University Hospital, Essen', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}