Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-25 @ 9:30 PM
Study NCT ID:
NCT04562051
Status:
RECRUITING
Last Update Posted:
2023-11-29
First Post:
2020-09-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Stratified vs Routine Prophylaxis in Living Kidney Transplantation From HBsAg+ Donors to HBsAg- Recipients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-09-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-27', 'studyFirstSubmitDate': '2020-09-11', 'studyFirstSubmitQcDate': '2020-09-17', 'lastUpdatePostDateStruct': {'date': '2023-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'composite outcome: prevention failure of HBV transmission from HBsAg+ donors to HBsAg- recipients', 'timeFrame': '2020.9-2025.10', 'description': 'The primary outcome is the incidence of prevention failure of HBV transmission from HBsAg+ donors to HBsAg- recipients, which is a composite endpoint. The composite outcome includes HBsAg - → +, HBV DNA - → +, HBeAg - → +, HBeAb - → +, HBcAb - → +, active liver function damage and death in the recipients. Liver function damage is defined as postoperative abnormal liver dysfunction (ALT \\> 60IU/L for females, and \\>75 IU/L for males; or total bilirubin \\> 34 umol/L); or postoperative ultrasonography reported hepatic cirrhosis in the recipient.'}], 'secondaryOutcomes': [{'measure': 'Graft loss', 'timeFrame': '2020.9-2025.10', 'description': 'Graft loss was defined as re-establishment of long-term dialysis or estimated glomerular filtration rate (eGFR) of \\<15 ml/min.'}, {'measure': 'biopsy-confirmed acute rejection', 'timeFrame': '2020.9-2025.10', 'description': 'biopsy-confirmed acute rejection was diagnosed clinically based on a significant increase in serum creatinine levels of 50% or more within 3 days, which was not explained by other reasons and confirmed by biopsy.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Kidney Transplantation', 'HBV']}, 'descriptionModule': {'briefSummary': "This is a multicenter, prospective, observational study to compare the efficacy and safety of stratified prophylaxis based on donors' and recipients' risk factors vs routine prophylaxis bases on clinical experience in living kidney transplantation from HBsAg+ donors to HBsAg- recipients. The follow-up period was 2 years after renal transplantation. The primary outcome was prevention failure of HBV transmission (any one of HBsAg - → +, HBV DNA - → +, HBeAg - → +, HBeAb - → +, HBcAb - → +, active liver function damage and death in the recipient)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Kidney transplantation from HBsAg+ donors to HBsAg- recipients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. patients diagnosed with end-stage renal diseases and suitable for living kidney transplantation;\n2. HBsAg+ donor was the only donor;\n3. age and sex of donors and recipients were unrestricted;\n4. ABO compatible or incompatible between the donor and recipient;\n5. The living donor voluntarily donates one of their kidneys to the recipient free of charge;\n6. The donor and recipient can understand the purpose and risk of living KT and sign informed consent;\n7. Ethics committee approved.\n\nExclusion Criteria:\n\n1. preoperative abnormal liver dysfunction in the donor or recipient (ALT \\> 60IU/L for females, and \\>75 IU/L for males; or total bilirubin \\> 34 umol/L); or preoperative ultrasonography in the donor or recipient reported hepatic cirrhosis;\n2. positive complement-dependent cytotoxicity cross-match test;\n3. combined HCV or HIV infection in the donor or recipient;\n4. diagnosed with malignancy or had a history of malignancy in the past 5 years;\n5. non-kidney transplantation history.'}, 'identificationModule': {'nctId': 'NCT04562051', 'briefTitle': 'Stratified vs Routine Prophylaxis in Living Kidney Transplantation From HBsAg+ Donors to HBsAg- Recipients', 'organization': {'class': 'OTHER', 'fullName': 'West China Hospital'}, 'officialTitle': 'Stratified vs Routine Prophylaxis in Living Kidney Transplantation From HBsAg+ Donors to HBsAg- Recipients', 'orgStudyIdInfo': {'id': 'WestChina-KT'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'stratified prophylaxis group', 'description': "The process of stratified prophylaxis was as follows. 1) If the recipient's HBsAb level is more than 100 IU/L and the donor is HBV DNA-, the recipient will not receive any preventive measures; 2) If the recipient's HBsAb is more than 100 IU/L and the donor is HBV DNA+, the recipient receives antiviral treatment for 1 month; 3) If the recipient's HBsAb is between 10 and 100 IU/L, the recipient is treated with single dose HBIG and antiviral treatment for 1 month regardless of the donor's HBV DNA status; 4) If the recipient's HBsAb is less than 10 IU/L, the recipient will receive single dose HBIG and antiviral treatment for 1 month regardless of the donor's HBV DNA status.", 'interventionNames': ['Other: prophylaxis regimen']}, {'label': 'Routine prophylaxis group', 'description': 'Transplant centers adopted routine prophylaxis based on clinical experience', 'interventionNames': ['Other: prophylaxis regimen']}], 'interventions': [{'name': 'prophylaxis regimen', 'type': 'OTHER', 'description': "All recipients were divided into two groups: stratified prophylaxis group based on donors' and recipients' characteristics and routine prophylaxis group based on clinical experience", 'armGroupLabels': ['Routine prophylaxis group', 'stratified prophylaxis group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '610041', 'city': 'Chengdu', 'state': 'Sichuan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Tao Lin, MD', 'role': 'CONTACT', 'email': 'kidney5@163.com', 'phone': '+8618980602093'}], 'facility': 'Tao Lin', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}], 'centralContacts': [{'name': 'Tao Lin, PhD', 'role': 'CONTACT', 'email': 'kidney5@163.com', 'phone': '+8618980602093'}], 'overallOfficials': [{'name': 'Xianding Wang, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Organ transplant center, Department of Urology, West China Hospital'}, {'name': 'Turun Song, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Organ Transplant Center, Department of Urology, West China Hospital'}, {'name': 'Yu Fan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Organ Transplant Center, Department of Urology, West China Hospital'}, {'name': 'Zhongli Huang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Organ Transplant Center, Department of Urology, West China Hospital'}, {'name': 'Saifu Yin, MB', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Organ Transplant Center, Department of Urology, West China Hospital'}, {'name': 'Hongtao Liu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital of USTC, University of Science and Technology of China'}, {'name': 'Wenjun Shang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital of Zhengzhou University'}, {'name': 'Honglan Zhou, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Hospital of Jilin University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'West China Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Tao Lin', 'investigatorAffiliation': 'West China Hospital'}}}}