Ignite Creation Date:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2026-02-25 @ 6:44 PM
Study NCT ID:
NCT05325008
Status:
RECRUITING
Last Update Posted:
2025-07-01
First Post:
2022-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial to Treat Polyomavirus Infections (BKPyV) in Kidney and Simultaneous Kidney Pancreas Transplant Recipients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012059', 'term': 'Rejection, Psychology'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}], 'ancestors': [{'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D007239', 'term': 'Infections'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016756', 'term': 'Immunoglobulins, Intravenous'}], 'ancestors': [{'id': 'D007074', 'term': 'Immunoglobulin G'}, {'id': 'D007132', 'term': 'Immunoglobulin Isotypes'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 280}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2029-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-29', 'studyFirstSubmitDate': '2022-01-10', 'studyFirstSubmitQcDate': '2022-04-04', 'lastUpdatePostDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite ordinal outcome based on all cause death, allograft loss, eGFR decline, acute allograft rejection or BKV load > 1000 copies/mL, and immunosuppression load.', 'timeFrame': '11 - 13 weeks', 'description': 'All participants will be allocated a rank at 12 weeks between rank 5 (worst) and rank 1 (best). The primary comparison of interest is between participants randomised to intravenous immunoglobulin (IVIG) and participants randomised to the control arm.\n\nOutcome measures include: Rank 5 - all cause death, allograft loss, eGFR decline ≥10mls/min 1.73². Rank 4 - acute allograft rejection or BK viral load to \\>1000 copies/mL. Ranks 3, 2, and 1 - the degree of immunosuppression reduction relative to baseline immunosuppression.'}], 'secondaryOutcomes': [{'measure': 'BKPyV final viral load', 'timeFrame': '12 weeks', 'description': 'Compare the number of participants in the intervention and control groups with a BK Polyomavirus viral load to \\<1000 copies/mL'}, {'measure': 'eGFR decline', 'timeFrame': '12, 24 & 48 weeks', 'description': 'Compare the number of participants in the intervention and control groups with an estimated glomerular filtration rate (eGFR) decline ≥ 10 ml/min/1.73 m2'}, {'measure': 'All cause death', 'timeFrame': '12, 24 & 48 weeks', 'description': 'Compare the mortality rate in the intervention and control groups.'}, {'measure': 'Graft loss', 'timeFrame': '12, 24 & 48 weeks', 'description': 'Compare the number of graft survival and death-censored graft survival participants in the intervention and control groups.'}, {'measure': 'Acute rejection of kidney and/or pancreas allografts', 'timeFrame': '12 & 48 weeks', 'description': 'Compare the number of acute rejections (cellular and antibody mediated) episodes between the intervention and control groups.'}, {'measure': 'Donor Specific Anti-HLA Antibody', 'timeFrame': '12 & 48 weeks', 'description': 'Compare the number of participants that develop de novo donor-specific antibodies between the intervention and control groups'}, {'measure': 'Infusion reactions and/ or venous thromboembolism events', 'timeFrame': '12 weeks', 'description': 'Compare the incidence rate (number) of infusion reactions and venous thromboembolism between the intervention and control groups'}, {'measure': 'Hospitalisations due to infection events', 'timeFrame': 'Baseline,1,2,3,4,5,6,7,8,10,12,24,48 weeks', 'description': 'Compare the number of hospitalisation due to infection between the intervention and control groups.'}, {'measure': 'Number of infectious events requiring antimicrobial (antibacterial, antiviral, antifungal, antiprotozoal) therapy.', 'timeFrame': 'Baseline,1,2,3,4,5,6,7,8,10,12,24,48 weeks', 'description': 'Compare the number of infectious events requiring antimicrobial therapy between the intervention and control groups'}, {'measure': 'EuroQol-5 Dimension-5 Level for adults/ Health Utilities Index-3 for children', 'timeFrame': 'Baseline, 12, 24 & 48 weeks', 'description': 'Compare the outcomes of health-related quality of life between the intervention and control groups.'}, {'measure': 'BK polyomavirus associated nephropathy events', 'timeFrame': '12 & 48 weeks', 'description': 'Compare the number of participants that develop BK polyomavirus associated nephropathy between the intervention and control groups'}, {'measure': 'Any cancer diagnosis or cancer related death', 'timeFrame': '24 & 48 weeks', 'description': 'Compare the incidence rate (number) of cancer outcomes between the intervention and control groups.'}, {'measure': 'Composite ranked outcome', 'timeFrame': '24 & 48 weeks', 'description': 'Compare the long-term composite ranked outcome between the intervention and control groups'}, {'measure': 'Adverse events of special interest and serious adverse events', 'timeFrame': 'Baseline,1,2,3,4,5,6,7,8,10,12,24,48 weeks', 'description': 'Compare the incidence rate (number) of safety related events between intervention and control group.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Kidney transplantation', 'Intravenous immunoglobulin', 'Virus', 'Nephropathy', 'Clinical trial', 'Nephrology'], 'conditions': ['BK Viremia', 'Kidney Transplant Infection', 'Kidney Transplant Failure and Rejection']}, 'referencesModule': {'references': [{'pmid': '39352862', 'type': 'DERIVED', 'citation': 'Helle F, Aubry A, Morel V, Descamps V, Demey B, Brochot E. Neutralizing Antibodies Targeting BK Polyomavirus: Clinical Importance and Therapeutic Potential for Kidney Transplant Recipients. J Am Soc Nephrol. 2024 Oct 1;35(10):1425-1433. doi: 10.1681/ASN.0000000000000457. Epub 2024 Jul 9.'}]}, 'descriptionModule': {'briefSummary': 'BEAT-BK will see the effect of immunosuppression reduction/modification with and without IVIG on BKPyV infection, allograft function, allograft loss, acute transplant rejection, immunosuppression load and death in kidney and simultaneous kidney pancreas transplant recipients with polyomavirus infections (BKPyV).', 'detailedDescription': "BKPyV infection is a rare but also devastating disease in kidney and SPK transplant recipients. Immunosuppression used in transplantation minimises the risk of acute rejection and eventual graft loss, but suppression of the immune system increases the risk of opportunistic infections and reactivation of latent viruses causing disease, such as BKPyV infection. Therefore, balancing the complications of excessive versus inadequate immunosuppression is a key priority for patients and health professionals. The BEAT-BK trial is designed through a structured, consensus process, and informed by the pilot observational data generated by the investigators. The conventional immunosuppression reduction approach may include judicious reduction in the doses of calcineurin inhibitors and anti-proliferative agents, or conversion to less potent immunosuppression therapy such as a switch from tacrolimus to cyclosporine, or mycophenolate to azathioprine. While adjuvant therapy is not commonly used, 63% of participants would consider IVIG as a 'rescue', when conventional therapy has failed, or the graft function is deteriorating rapidly. IVIG is a nondepleting agent containing natural antibodies with potential antiviral and immunomodulatory properties. It is used against some chronic infections (Epstein-Barr virus) and the treatment of antibody-mediated rejection in kidney transplantation. In BKPyV infection, the certainty of the evidence for IVIG is very low due to imprecision, and high risk of bias (small, case series, retrospective cohorts), but it holds promise based on findings from our observational data (n = 50). Recipients with BKPyV-DNAemia who received IVIG as adjuvant therapy were more likely to achieve complete viral clearance at 12 months (77.3% vs. 33.3%, p \\< 0.01) and less likely to relapse (11% vs. 27.3%, p=0.01) compared to recipients who received conventional therapy alone."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged 2 years or above\n2. Have received a kidney or simultaneous pancreas-kidney transplant\n3. Have BKPyV-Viremia (detected by RT-PCR) with a viral count ≥ 5,000 copies per mL, or histological confirmation of BKPyVAN, within 3 weeks prior to randomisation.\n4. Be able to provide informed consent or consent given by a parent or guardian (if age \\<18 years) or other authorised person\n\nExclusion Criteria:\n\n1. Contraindications to receiving IVIG as a treatment\n2. Current active acute rejection (≤ 3 months prior)\n3. Treating clinicians would regard as unsafe to be enrolled\n4. Limited life expectancy (\\< 12 months)\n5. Receiving Belatacept as part of their immunosuppression protocol\n6. Currently undergoing or who have previously received, viral-specific T-cell therapy for BK viremia\n7. Prior infection and treatment for BKPyV-Viremia\n8. Received IVIG treatment in the past with last IVIG treatment \\< 4 weeks prior to randomisation'}, 'identificationModule': {'nctId': 'NCT05325008', 'acronym': 'BEAT-BK', 'briefTitle': 'A Trial to Treat Polyomavirus Infections (BKPyV) in Kidney and Simultaneous Kidney Pancreas Transplant Recipients', 'organization': {'class': 'OTHER', 'fullName': 'The University of Queensland'}, 'officialTitle': 'An Adaptive Randomised Controlled Trial to Treat Polyomavirus Infections (BKPyV) in Kidney and Kidney Pancreas Transplant Recipients', 'orgStudyIdInfo': {'id': 'AKTN 20.07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Immunosuppression reduction/modification + Intravenous Immunoglobulin', 'description': 'Receives Immunosuppression reduction/modification + Intravenous Immunoglobulin', 'interventionNames': ['Drug: Immunosuppression reduction/modification + intravenous immunoglobulin']}, {'type': 'OTHER', 'label': 'Immunosuppression reduction/modification', 'description': 'Receives Immunosuppression reduction/modification as part of standard of care.', 'interventionNames': ['Other: Immunosuppression reduction/modification']}], 'interventions': [{'name': 'Immunosuppression reduction/modification + intravenous immunoglobulin', 'type': 'DRUG', 'otherNames': ['Human immunoglobulin'], 'description': 'Participants will receive intravenous immunoglobulin along with immunosuppression reduction/modification.', 'armGroupLabels': ['Immunosuppression reduction/modification + Intravenous Immunoglobulin']}, {'name': 'Immunosuppression reduction/modification', 'type': 'OTHER', 'description': 'Participants will receive immunosuppression reduction/modification.', 'armGroupLabels': ['Immunosuppression reduction/modification']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2605', 'city': 'Canberra', 'state': 'Australian Capital Territory', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Andrea Blanco', 'role': 'CONTACT', 'email': 'Andrea.Blanco@act.gov.au', 'phone': '02 5124 2146'}, {'name': 'Lizanne Mackintosh', 'role': 'CONTACT', 'email': 'Lizanne.Mackintosh@act.gov.au', 'phone': '02 5124 2526'}, {'name': 'Krishna Karpe', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Canberra Hospital', 'geoPoint': {'lat': -35.28346, 'lon': 149.12807}}, {'zip': '2305', 'city': 'New Lambton Heights', 'state': 'New South Wales', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Denise Jones', 'role': 'CONTACT', 'email': 'Denise.jones@health.nsw.gov.au', 'phone': '02 4921 4332'}, {'name': 'Melissa Mulholland', 'role': 'CONTACT', 'email': 'Melissa.Mulholland@health.nsw.gov.au', 'phone': '02 4921 4332'}, {'name': 'Thida Myint', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Eswari Vilayur', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'John Hunter Hospital', 'geoPoint': {'lat': -32.92466, 'lon': 151.69364}}, {'zip': '2031', 'city': 'Randwick', 'state': 'New South Wales', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Sophie Cheng', 'role': 'CONTACT', 'email': 'Sophie.Cheng@health.nsw.gov.au', 'phone': '(02) 9382 4444'}, {'name': 'Hannah Kim', 'role': 'CONTACT', 'email': 'Jong.Kim1@health.nsw.gov.au', 'phone': '(02) 9382 4418'}, {'name': 'Kenneth Yong', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Prince of Wales Hospital', 'geoPoint': {'lat': -33.91439, 'lon': 151.24895}}, {'zip': '2050', 'city': 'Sydney', 'state': 'New South Wales', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Sophie Cheng', 'role': 'CONTACT', 'email': 'sophie.cheng@health.nsw.gov.au', 'phone': '+61 2 9382 4444'}, {'name': 'Kate Wyburn', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Royal Prince Alfred Hospital', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'zip': '2145', 'city': 'Sydney', 'state': 'New South Wales', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Siah Kim', 'role': 'CONTACT', 'email': 'siah.kim@health.nsw.gov.au', 'phone': '+61 421454723'}, {'name': 'Siah Kim', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Childrens Hospital Westmead', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'zip': '2145', 'city': 'Westmead', 'state': 'New South Wales', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Penelope Murrie', 'role': 'CONTACT', 'email': 'Penelope.Murie@health.nsw.gov.au', 'phone': '02 8890 6848'}, {'name': 'Sana Hamilton', 'role': 'CONTACT', 'email': 'sana.hamilton@health.nsw.gov.au', 'phone': '02 8890 3883'}, {'name': 'Germaine Wong, Professor', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Dharshana Sabanayagam, Doctor', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Western Sydney Local Health District (Westmead Hospital)', 'geoPoint': {'lat': -33.80383, 'lon': 150.98768}}, {'zip': '4101', 'city': 'Brisbane', 'state': 'Queensland', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Sophie Anderson-James', 'role': 'CONTACT'}, {'name': 'Anna Francis', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Queensland Children's Hospital", 'geoPoint': {'lat': -27.46794, 'lon': 153.02809}}, {'zip': '4102', 'city': 'Woolloongabba', 'state': 'Queensland', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Rachael Hale', 'role': 'CONTACT', 'email': 'Rachael.Hale@health.qld.gov.au', 'phone': '07 3176 6325'}, {'name': 'Diana Leary', 'role': 'CONTACT', 'email': 'Diana.leary@health.qld.gov.au', 'phone': '07 3176 6325'}, {'name': 'Samantha Ng', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ross Francis', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Princess Alexandra Hospital', 'geoPoint': {'lat': -27.48855, 'lon': 153.03655}}, {'zip': '5042', 'city': 'Adelaide', 'state': 'South Australia', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Merin Kuriakose, CN', 'role': 'CONTACT', 'email': 'Merin.Kuriakose@sa.gov.au', 'phone': '(08) 8204 6281'}, {'name': 'Fleur Tuthill, CN', 'role': 'CONTACT', 'email': 'Fleur.Tuthill@sa.gov.au', 'phone': '(08) 8204 6281'}, {'name': 'Rajiv Juneja', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Flinders Medical Centre', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'zip': '3168', 'city': 'Melbourne', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Rita Barbis', 'role': 'CONTACT', 'email': 'rita.barbis@monashhealth.org', 'phone': '03 9594 3523'}, {'name': 'Laura Chen', 'role': 'CONTACT', 'email': 'laura.chen2@monashhealth.org', 'phone': '03 9594 3049'}, {'name': 'John Kanellis', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Monash Health', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '6009', 'city': 'Perth', 'state': 'Western Australia', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Nick Larkins', 'role': 'CONTACT', 'email': 'Nicholas.Larkins@health.wa.gov.au', 'phone': '+61 8 6456 2222'}, {'name': 'Nick Larkins', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Perth Children's Hospital", 'geoPoint': {'lat': -31.95224, 'lon': 115.8614}}, {'zip': '6009', 'city': 'Perth', 'state': 'Western Australia', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Wai Lim', 'role': 'CONTACT', 'email': 'wai.lim@health.wa.gov.au', 'phone': '+61 8 6457 3333'}, {'name': 'Wai Lim', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sir Charles Gairdner Hospital', 'geoPoint': {'lat': -31.95224, 'lon': 115.8614}}], 'centralContacts': [{'name': 'Peta-Anne Paul-Brent', 'role': 'CONTACT', 'email': 'beat-bk@uq.edu.au', 'phone': '+61 411 397 776'}, {'name': 'Pushparaj Velayudham', 'role': 'CONTACT', 'email': 'beat-bk@uq.edu.au', 'phone': '+61 438 077 278'}], 'overallOfficials': [{'name': 'Germaine Wong, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Sydney'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Queensland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}